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Europe’s drug regulator set out guidelines for copying some of the most expensive biotechnology medicines, giving companies such as Novartis AG and Teva Pharmaceutical Industries Ltd. access to a $36.4 billion market.
New Bio-similars Monoclonal antibody copies would be a new type of bio similar, a copy of a medicine designed to mimic substances found in the body such as hormones. Conventional generic drugs are copies of treatments for high blood pressure or pain, and often don’t resemble biological compounds. Bio similars have been sold in Europe since 2005. Companies use genetically engineered cells to make bio similars, and conventional generics are manufactured by chemical reactions in large vats. The guidelines released today establish the kinds of tests and studies needed to show the copy is similar to the branded drug. Companies will have to submit their products to human trials, though they will usually be less extensive than those needed for the approval of a branded antibody. The agency may accept trials that forgo the use of a control group, and compare the generic with the original. The regulator also may accept data gathered to support the application of a treatment in one illness to support approval for other uses.
As the 20th Partnerships in Clinical Trials approaches next April, we wanted to you get to know the staff behind the event. Every two weeks, a Partnerships Team Member will share some of their memories and experiences with the event. Today, we have Allison Rigels Nilsen, the Senior Marketing Manager of this year's event.
1) What do you do for Partnerships in Clinical Trials? How long have you been working on the Partnerships Event? I am the Senior Marketing Manager for the Partnerships event and I have been working on the event for the past 4 years.
2) What is your favorite part of working on this event year after year? Year after year the industry around us is changing and it’s exciting for me to see how this event has continued to grow. Our relationships with the speakers and partners have strengthened and become an integral part of the success of this event.
3) Which conference has stood out in your mind and why? Who has been your favorite speaker at Partnerships? My favorite year was 2008 when it was held at the Mandalay Bay in Vegas. Attendance was at an all time high and everyone there just had positive things to say. That year Magic Johnson was one of the keynote speakers. His message was inspiring and hit home for many of the people in the room.
4) What’s your favorite food? Pizza! I love trying new pizza places in New York. I even heard about a Pizza Tour in Brooklyn that I have to try!
5) What are you looking forward to the most for our 20th Anniversary? For the 20th Anniversary celebration we have some surprises in store that I can’t give away. You’ll just have to attend the event to see! I have enjoyed delving into the content development for the 2011 program in order to bring forth more advanced sessions as well as many new topics for the meeting. I am working closely with speakers to develop innovative interactive formats for our conference sessions. I am also excited for some of the "surprises" we are developing for our 20th Anniversary celebration, and for building a more active and engaged Partnerships community.
The length and complexity of consent forms for people enrolling in clinical trials don't affect the ability of the participants to understand the key points of the study.
This is true for Bio equivalence studies in USA as well.
In this new study, U.S. researchers had volunteers read either a standard or a concise consent form for a low-risk phase 1 study of a marketed drug. The participants' comprehension levels were similar with both forms, and the shorter form didn't appear to harm the quality of informed consent, the study authors found. The researchers also noted that paid participants had slightly higher comprehension than unpaid participants. This challenges a common assumption that people who are paid to enroll in research may be "blinded by money" and thus ignore important details about the study when reading the consent form.
Partnerships in Clinical Trials is taking place this March 30-April 1, 201a in Phoenix, Arizona. Every Friday leading up to the 20th anniversary of the event, we'll be recapping one session from Partnerships in Clinical Trials.
Workshop Presenters: Rikki Bouchard, President and CEO, RH BOUCHARD AND ASSOCIATES Jessica Bowler, Associate Director, Worldwide Procurement, PFIZER Wendy Chapman, COO and Vice President, Clinical Operations, VIVENTIA BIOTECHNOLOGIES INC Cindy Markham MPH, Executive Director, Business Development, PPD, INC
In the outsourcing environment prevalent in the pharma industry, selecting a component Contract Research Organization (CRO) is crucial. The RFP process is the most common way to find a suitable partner that fits. But the outcome of an RFP is only as good as what goes into it. This was the topic of the afternoon workshop titled, “Provider Selection and the Request for Proposal Process.”
The speakers walked us through the main steps, best practices and most common failure points of RFPs. As with most things, good upfront preparation pays big dividends. Determining strategy (Why outsource? Who? How?), interviewing internal stakeholders and making sure the strategy aligns with your business model are key. Also, being honest about your company’s core competencies will help decide whom you should partner with to fill in the holes.
The actual selection process begins with the Request for Information (RFI) to gather enough information to pare down to a short list of providers. It should identify key criteria for selection, probe for information beyond sales speak, utilize open communication throughout the process and be graded with a weighted scorecard for optimal results. The short list that comes out of this RFI will be a list of a handful of companies that will then respond to the more detailed RFP for a specific study.
Clinical study RFPs are often riddled with inconsistencies and errors which can tilt the playing field and hamper an accurate analysis of responses. Table format is easiest to collect succinct, focused responses in an easily-analyzed fashion. Roles and responsibilities must be sharply defined. Working collaboratively with the responding CROs in the RFP process sets the stage for a future relationship. Remember, one of these companies will be trusted with your company’s product and future. So move past the vendor selection mindset and towards a more transformative partner development. Starting with a good RFP is a great place to begin.
Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!
52 Perspectives: “ePatients. Hot or not”?
This contribution to ’52 Perspectives’ comes to us from Dan Sfera, the Site Liaison for South Coast Clinical Trials. Dan is also responsible for the business development at the South Coast Clinical Trials, a specialized research company widely recognized as one of Southern California’s premier providers of clinical trials for Central Nervous System disorders and conditions such as bipolar disorder, schizophrenia, depression, Alzheimer’s Disease among many others. Dan runs a popular blog called The Clinical Trials Guru, which does a great job at discussing clinical trials in plain English.
Introduction
An industry hot topic that has began surfacing over the past few years, and seems to be picking up steam is the concept of the epatient. Websites such as patientslikeme.org, curetogether.com and iguard.org let you store your personal health info as well as collaborate with other individuals who may be taking the same medications as you or share similar symptoms, illnesses, etc. From a non-clinical trial perspective, the benefits of keeping records of your personal medical history are obvious. You can now inform your physician of your current condition and keep him updated in almost real time on your progress. An excellent blog I recently discovered that covers this topic, and is written by a guy who started keeping a history of his own medical records is http://epatientdave.com.
From a clinical trials perspective, study participants keeping track of their own medical records and being able to retrieve them when required for study participation is an Investigator’s dream come true. One of the biggest factors attributed to clinical trial study delays are slow enrollment rates by Investigative Sites. Slow enrollment rates are often due to Investigators being unable to obtain adequate medical records for the individuals who have an interest in joining the studies. If this problem is eliminated by more individuals keeping up to date records of their medical histories, enrollment rates can be rapidly enhanced. From this perspective, you can see why Big Pharma is pushing for this epatient movement to overlap itself right into the clinical trials space. However, as with all things Pharma, the real reason for their support for this movement may very well be less about patient empowerment and more about dollars and cents.
One of the natural assumptions is that this epatient can, with assistance from pharmaceutical companies and a small group of physicians, conduct their own clinical trials without having a research clinic responsible for collecting data from the patient himself. We have already started seeing this with patient diaries and other types of data collection devices that the patients themselves are solely responsible for keeping. While one can certainly see how Pharma can save a lot of money by gradually shifting more and more responsibility away from the Investigative Site and simultaneously giving more of this responsibility to the patients themselves, the truth of the matter is, study protocols are becoming increasingly more complex as the FDA is getting stricter on adverse event reporting and safety data needed before they are willing to approve a new drug. Good luck getting that epatient to give himself an EKG! However, you can bet that Pharma will do what it can to reduce costs required to conduct clinical trials, so the idea of the epatient study participant will become more and more prevalent. We have already seen Pharma begin to outsource more clinical trials in countries such as China and India, and we at TheClinicalTrialsGuru.com believe that this trend will continue. Combine Pharma’s need for reducing drug development costs along with Health Care Reform and you have the perfect storm necessary to make a push for further integrating epatients into clinical trials while eliminating some responsibilities from the Investigative Site level.
Should Investigators be alarmed?
The rise of the epatient in clinical trials should not alarm Investigator Sites, but they should be aware of this movement. For the time being, the idea of completely eliminating the Research Clinic from the clinical trials process is still a long way from actually happening. Furthermore, studies in certain therapeutic indications such as Alzheimer’s, Cancer, Diabetes and other chronic diseases or life threatening conditions can never be conducted by the epatient himself. However, in some clinical trials such as Depression, Pain, or Hypertension, the epatient can actually collect much of the data that Investigator used to collect and record. The general rule can be that the less complex the protocol is for a particular clinical trial, the more likely it will be for a group of epatients, supervised by a small group of physicians to conduct and implement the majority of the study procedures required for that particular clinical trial. In these cases, drugs can potentially be brought to market faster, cheaper, and perhaps safer. For the more complex protocols, these types of clinical trials would be impossible to conduct without the Research Center’s heavy involvement. In my humble opinion, the epatient movement into clinical trials is inevitable, but not necessarily a movement to turn this industry upside down as some may fear.
SCCT was founded in 2001 by Dr. Adonis Sfera, M.D. who has been serving the community in his general and geriatric pyschiatry private practice for more than 15 years, and who continues to do so at our principal trial site in Anaheim. Dr. Sfera created SCCT in hopes of aiding in the discovery of new and more effective treatments for the very challenging disorders and conditions he encountered daily in his practice. He has since assembled a team of highly experienced professionals to assist in bringing these promising treatments to the people who need them.
Dan Sfera, BS, MBA, is a regulatory and contract specialist, is responsible for business development and is the Anaheim Site Director. In addition, Mr. Sfera is the Site Liaison for the company and is in charge of obtaining new studies as well as handling all of the necessary study start-up activities for our multiple sites. Dan serves as the liaison between South Coast Clinical Trials and SCCT’s pharmaceutical sponsors or Contract Research Organizations, ensuring that each and every facet of the trials are in full compliance with the Food and Drug Administration and Institutional Review Boards.
About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com
Deal Consequence EU-India deal could threaten access to essential HIV drugs. As Indian and European officials meet in Brussels to thrash out the details of a Free Trade Agreement (FTA), civil society activists are concerned the deal could mean tighter intellectual property protections that could reduce access to cheap Indian generic drugs.
"The European Union is pushing for data exclusivity, which means Indian generics manufacturers would no longer be able to use existing studies to make identical drugs, a practice recommended by WHO [UN World health Organization] – they would have to conduct their own clinical trials, which would be unethical and redundant since we already have evidence that the drug works, but also, the data exclusivity could last anywhere between five and 10 years, delaying poor countries' access to these drugs for long periods," Michelle Childs, director of policy and advocacy for Médecins Sans Frontières' campaign for access to essential medicines, told IRIN/PlusNews.
More than 80 percent of all donor-funded antiretroviral drugs used in developing countries are Indian generics; the availability of cheap ARVs has enabled more than five million people globally to access essential HIV treatment. Until 2005, the country did not grant patents on medicines, but World Trade Organization (WTO) rules now require India to grant patents. Indian law only grants patents on drugs that show a therapeutic benefit over existing ones; activists fear that trade agreements like the EU-India one could override these public health concerns.
The 20th Annual Partnerships in Clinical Trials agenda is now available! In this time of transformational change, Partnerships is your opportunity to meet face to face with nearly 2,000 peers and over 200 solutions providers ready to help meet your trial needs. We invite your to review our agenda for 2011 and choose from a wide array of 6 in-depth workshops, 6 customized tracks and 3 co-located events that drill down into the issues most challenging to outsourcing, development/operations, business, safety, and CRO professionals today.
Did you know the 20th Annual Partnerships in Clinical Trials Offers: • 150+ Intermediate and advanced sessions • 75 Brand new sessions and workshops • 15 Sessions back by popular demand • 12 Sessions on globalization and emerging markets • 3 New events for investigators, site management professionals, medical device professionals and biotech executives
Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!
10 Steps to Clinical Study Startup: Step 5 – The Pre-Study Visit (PSV)
Step 5: This is the fifth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!
Introduction
There has been a lot of discussion about the topic of the pre-study visit over the years. Much of this discussion has come about due to a possible disconnect between sponsor or CRO objectives and expectations when compared to those of the research site.
It remains the case that in order for a sponsor or CRO to find the number of research sites they need for a given protocol, they must engage in discussions with sites with which they have no previous experience. And it remains the case that there is no other way to collect information about potential sites than to initially rely on the site’s own, self-reported metrics and information.
This necessitates that the sponsor or CRO will inevitably perform what is called the pre-study visit (PSV). If there is some previous experience with the site in question this visit may be foregone in favor of a pre-study phone call.
Some objectives (sponsor/CRO) of the PSV are:
Validate site claims made on SFQ and in previous discussions during site ID
Evaluate condition of site
Review essential study documents
o Protocol o Source Docs o ICF
Review patient recruitment strategies
Review advertising campaigns
Provide training
Special set-up
Meet PI to gain comfort regarding his/her ability and interest for the protocol
The PSV is oftentimes viewed as a necessary evil by the site. This is mostly due to the inconvenience in hosting a study monitor for what is often a full day (can be longer). This inconvenience translates to the site, a real expense in terms of resources required to adequately prepare for and conduct the PSV; resources which typically are not reimbursed. It is considered a cost of doing business. However, the PSV also is an excellent opportunity for a site to make a good impression and get off on the right foot with their sponsor and CRO customer.
Tips for a successful PSV:
-Be prepared!
*This goes for the site as well as the sponsor/CRO. It is not uncommon for sites to receive multiple calls rescheduling the PSV. Common complaints from sites include hosting ill-prepared monitors. Likewise, common complaints from sponsors/CROs, include lack of adequate preparation by site staff, including PIs.
-Be professional!
*This may seem elementary, but unfortunately, it is common for this concept to be lost on individuals when conducting PSVs. All parties from both sides should not have a mindset of this being an adversarial event; rather an approach that both parties are entering into a professional relationship of mutual benefit and interest.
*The site should be prepared to host this meeting, keeping in mind the responsibilities of any good host: make the environment comfortable and welcoming, accommodate, prepare, and maintain a pleasant and professional demeanor. Likewise, the company and person making the visit should do all in their power to take in consideration the inconvenience to the site and the resources they must expend to make it a successful meeting.
-Take advantage of face-to-face time to build a stronger business relationship.
*Often, this is the first meeting between a company as well as probably the individual with whom the site will work if they are chosen to participate in the trial. Keep in mind that the vast majority of sites hosting a PSV will be selected and activated on the study. Sponsors and CROs do not take the decision to spend their resources on PSVs lightly. From a business development angle, this meeting is an opportunity to make an excellent first impression; which will pay dividends in future business with the sponsor and CRO. This is a site and PI’s opportunity to show ability, expertise, and most of all, interest in the particular protocol. Conduct at a PSV will often set the stage for relationship management throughout the completion of the protocol in question. If it starts well, often that is the overall impression throughout the trial; likewise, if it begins with conflict – conflict can be predicted throughout.
A final and very biased opinion of this author on PSVs: strong consideration should be made by the collective participants in this industry (sites, sponsors, and CROs) to provide a monetary reimbursement to sites for PSVs. Something reasonable and more than nominal should be provided to the site/PI for this activity. It is common for study budgets to include line items such as non-refundable start-up fees, but it is also common for these fees not to be itemized and thus they fall short of providing comprehensive coverage for site start-up costs. I feel safe in voicing this opinion because there are far more PIs and sites in the world than sponsors and CROs, so I believe I am arguing for the “majority” and most readers will agree.
About the authors:
Allan Valmonte is a Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward.
Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley.
Dan Manak is a Senior Director of Business Development at goBalto and a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.
About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com
In a recent article at Outsourcing Pharma, ACRO Vice President called for more oversight from the FDA and EMA over the clinical trials in developing countries. John Lewis is calling for a $17 million increase to the budget for the FDA's Office of International Programs. This comes just days after a report called for more of the FDA’s international offices to ensure the quality of drug manufacturing.
Should the FDA contribute more to monitoring clinical trial sites around the globe? As an international enterprise that affects all around the globe, how can we make sure monitoring the quality of clinical trials is the same in the US as it is in developing countries?
Market Overview – ANDA submissions In the Year 2009, a record Breaking number of ANDA’s were filed by the by the world’s leading generic drug players. In the year 2009, 100 ANDA’s were filed by the top 10 companies. The top 10 companies account for more than 50% of the total filed ANDA’s. Some of the top Indian companies which have driven the growth of the ANDA market are Wockhardt, Glenmark, Dr. Reddy, Aurobindo and Ranbaxy to name a few. The Indian Pharmaceutical Industry accounts for nearly 32% of the total filed ANDA’s in the year 2009.
Based on these statistics, it can be definitely predicted that growth of the Indian Pharmaceutical companies is likely to achieve its desired milestones. This can only happen f the regulatory laws continue to support the submission rates. The Healthcare reimbursement policies highlighted by the US government clearly favour the use of generic drugs. However, the nature by which the Indian Pharmaceutical companies tackle the “Pay for Delay” / patent litigations, will decide the future of the ANDA submissions.
In order to you to connect with your Partnerships Community the way you want to, we've created the Partnerships in Clinical Trials Facebook Group. You can click here to join the Facebook group, and continue your Partnerships experience year round.
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Partnerships in Clinical Trials is taking place this March 30-April 1, 201a in Phoenix, Arizona. Every Friday leading up to the 20th anniversary of the event, we'll be recapping one session from Partnerships in Clinical Trials.
Workshop Presenters: Mike Tanguay, BPharm, PhD, VP, Scientific Affairs, Anapharm, Inc Eric Masson, PharmD, Director, Clinical Pharmacology, Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb
The first presentation (Dr Tanguay) covers first in human trials for novel chemical entities. Dr Tanguay explores the trends driving more complex Phase I studies, the application of creativity in Phase I study design to enhance the scope of data obtained, and specifically the increased interest in evaluating QT potential within First in Human studies.
Attention to Study Drug Formulation: A key issue can be formulation and particularly with the frequency we see poorly soluble compounds. The speaker explores appropriate formulation optimization in the face of the demand for expediting initial study timelines. Noteworthy is that about half the time the formulation is simply a powder in bottle at the time of study initiation.
Keeping the Primary Objectives in Mind: Objectives of Phase I trials are reviewed including the specific examination of dose and dose range suitability for future studies and covering such topics as how to determine the maximum recommended starting dose in light of the EMEA Guidance for FIH trials published in 2007. NOAEL safety factor of 10 was applied in approximately 40% of trials reviewed.
Subject Population and Cohort Size: Patient population selection including entry criteria for aged and gender specific populations are discussed including when to introduce cohorts of the appropriate disease target population. Factors for inclusion of females of childbearing potential are reviewed and covered areas such as drug half-life. It is reported that only 11% of studies are male only and about 2/3 of trials currently include women of childbearing potential.
Number of subjects per cohort for typical MAD studies is optimized as 6 on active drug and 2 placebos. Six subjects should be sufficient to detect an adverse event with a frequency of 25% using an 80% probability level.
Dose Escalation and Timing: Dose escalation in these types of studies is managed on a case-by-case approach and guided by drug class. Classical approaches include doubling the dose at each cohort, a Fibonacci approach, etc. Ninety percent of studies will follow a doubling protocol for the low dose ranges while higher dose ranges will observe a more conservative model.
Interim blinded PK data analysis is recommended here despite the potential for study timeline effect the case being made for allowing more precise determination of stopping criteria in escalating dose studies.
It is pointed out that dosing strategy is coming under more scrutiny by regulatory bodies and should be well defined and utilize conservative staggering models within the protocol.
Study Design: The advantages of parallel versus cross-over designs are reviewed. While parallel designs may be generally considered safer as an approach to escalating dose studies, cross-over studies limit the number of subjects that need to be recruited. Since PK is not generally considered a first priority within a FIH study the author reviews various hybrid approaches. Examples are given within the slide deck accessible on the Partners 2010 website. Currently, the author states that about 20% of trials employ some type of hybrid approach.
Integrating Studies to Obtain Efficiencies: Efficiency in a Phase I program is driven by the need for obtaining proof of concept data as well as sponsor requirements for more data per trial. Integrated Phase I protocols are becoming more common. Forty percent of the authors are studies are now integrated SAD/MAD studies or studies including an additional are to elucidate food effect or, more rarely, effects on CYP2D6 poor metabolizers.
The author presents several case studies of ‘integrated’ SAD/MAD studies stating that this type of integrated trial has increased 4-fold in his clinic over the past year. It is stressed that an SAD cohort should have been completed at a higher dose than any pending MAD dose cohort in order to maintain a conservative safety margin within the higher risk study design. Drawbacks to this type of integrated study include inability to fully evaluate the SAD study prior to initiating the MAD study.
TQT studies are discussed in the context of obtaining intensive cardiac data within the escalating dose or FIH study. Advantages would include evaluation of electrocardiograms at substantially high doses prior to a full TQT study. Since positive controls are not employed this will not substitute for a complete TQT study and may or may not support a waiver for future TQT analysis.
Conclusions: In concluding the author reviewed questions frequently asked by Institutional Review Boards and regulatory agencies including Health Canada in considering First in Human Studies as well as guidance documents available to study design teams.
The second (Dr Masson’s) presentation comprises a case study on the conduct of Phase I Oncology studies and explores the use of healthy and patients.
Cytotoxics: Cytotoxicity has generally dictated the use of patients, however, recently, the development of targeted therapeutics has opened the way for using healthy volunteers. About 6 products of this class are presented were enumerated. The type of studies and compounds suitable for use of normal healthy volunteers (NHV) were explored as well as those precluding their use.
The use of NHV is attractive from a costs and resource perspective as well as timing. The cases reviewed compared use of NHV versus patients across several types of studies and concluded that a 2 to 3 fold savings can be achieved if NHV can safely be employed.
Biologics: The use of biologics and specific considerations including cytokine release was reviewed and appropriate study design (starting dose, etc) in light of half-life was discussed.
SAD/MAD studies are employed to define maximum tolerated dose and minimum biologic effect. Within this context the author discusses the use of combination drugs and the danger of overlapping toxicity along with the utility of SAD/MAD studies to categorize these risks.
QT/QTc studies in oncology were discussed along with potential confounding factors including excluding patients at extreme risk, con-meds, and electrolyte imbalance precipitated by patient nausea and vomiting.
Case Study: The author presents an ‘in-depth’ case study of the studies employed in the development and subsequent approval including the initial SAD study, the MAD study in patients with solid tumors, Food effect, ADME, and hepatic impairment. Drug-Drug interaction studies were completed in NHV subjects at drug levels comparable to those achieved in patients.
Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!
52 Perspectives: “Insights into Patient Recruiting and Managing Clinical Trials”
Jae Chung
Picture 1This week’s contribution to ’52 Perspectives’ comes from Debbi Lindgren-Clendenen, APRN-BC, GNP and Vicki Carmack, both Principal Consultants at NaviGo Research, a full service contract research organization providing clinical trial guidance and resources to the Medical Device, Pharmaceutical and Biotech industries.
1. What are some steps your company takes to make the recruitment process go smoothly and successfully?
Recruitment starts with a good protocol inclusion/exclusion definition. This ensures that the inclusion and exclusion criteria of patient enrollment are very clear, precise, and applicable to your cohort for the desired data outcome. There are many different types of recruitment tools and novel approaches to this phase of a clinical trial. A common, successful approach is to request your investigator, during the qualification visit, to address an approximate number of patients he or she feel they may be able to approach at their site in screening for your trial and potential enrollment. This gives the Sponsor an educated guess for this site in relationship to its location and patient demographic,
Follow up and tracking of the site’s recruitment is critical. Ask these questions of each site: How well are they performing this task? Are they meeting their stated enrollment goals? Are they keeping up on patient recruitment or was it just an initial push at the kickoff of the trial? Do they revise strategies often if their initial plan is not working? Answering these questions for each site and tracking enrollment is key for the sponsor. Decide prior to the start of the trial, what different recruitment techniques may be implemented at sites that are struggling and ensure that they are allowed by IRB(Institutional Review Board)/EC(Ethics Committee) and individual site.
Printing small pocket sized cards of the inclusion/exclusion criteria is another common practice that sponsors will implement to help research coordinators in successful subject recruitment.
2. How do you ensure that the subjects in clinical trials have a good general understanding of the research being done to them?
The informed consent process is critical for any trial. Regulations for consent content and IRB/EC requests must be followed. Regulations at an international, national, regional and local level must be incorporated into the subject consent form. Proper consenting starts with the ability to understand the information within the consent form and the ability of the investigator to communicate to the subject the trial’s methodology, the instructions of how the investigatory product will be used, and the potential risks and benefits might be for inclusion into the study. The supportive information is typically contained in the IFU (Instructions for Use), Investigator’s Brochure and ROP information. The language used by the investigator and the supporting materials, including the informed consent document, must be at an educational level appropriate for the desired subject population. This level is typically targeted at a fifth/sixth grade reading level. A documented consent process of verbal information, which includes common subjects’ questions and the investigator center’s answers, must be obtained as well as the documented evidence that the consent form was reviewed and understood by the patient.
A witness or representative/guardian of course must be used as applicable in the situations needing this provision. Consenting prior to any trial activity is a must and must not be perceived as being obtained under any duress of decision. Researchers should give plenty of time for the subject to review prior to signing, ask questions, consult with family members or others in order to make proper determination of involvement and understanding of what they are about embark upon as part of the clinical trial.
3. Does the government in your country play a role in educating citizens who participate in clinical trials? How?
Yes. In the United States, there are many different websites and clinical trial information centers that are both sponsored by the government and/or from the private sector that can help answer research questions and educate subjects on the research process. FDA (Food and Drug Administration) regulations and EU (European) standards are specific to assuring subjects have pertinent information prior to trial participation. Subjects involved in global clinical research may now retrieve various technical support information as well as request mailed information on similar products and preliminary clinical trial information regarding safety and effectiveness.
4. Give me an example of a public-private partnership between your government and a contract research organization like yourself that really worked.
The FDA potentially publicly partners with all sponsors of medical device clinical trials in the sense of offering the opportunity to discuss the specifics of the company’s investigational product approach for marketing approval as well as reviewing the trials main objectives and statistical approaches prior to its submission to the FDA for formal review.
As a contract research organization, we have been involved in these partnerships on behalf of our customers (the sponsors) representing them in these discussions with the government. These partnerships are never private. Many of the customers that we have worked with in the past have placed high value on the FDA pre-trial discussions as it provides valuable insight into options that may provide a better or more efficient approach to marketing approval outcomes
5. What does your company do in clinical trial documentation and analysis that increases success for new drug approvals?
We work with both Device and Drug approvals using our proprietary data management software. Our data management services as well as trial management services have increased success in many trials for our clients by capitalizing on its built-in efficiencies. Our ability to have validated services with real time data entry, review, and reporting have helped many clients achieve their research data goals by reviewing the data at any given time during the trial. In addition, the valid and prompt reporting using real-time data analysis has been key. Compliant trial conduct using our clinical trial management software has been a highly requested service by our clients. We also offer management and set up of data review committees such as DSMB (Data Safety and Monitoring Board) and CEC (Clinical Events Committee) that real-time management of adverse event data during the trial as well as the ability to code it using MedDRA. This promotes speedy set-up times for these committee meetings, thus resulting in full adjudication, then assessment.
Using our services and systems for trial data management, trial development, management, and compliance maintenance can reduce common errors. We pride ourselves in achieving the most efficient process of trial set up and data collection, keeping in mind our clients resources and being efficacious with them. Ultimately, this should help in the process of reaching the desired trial endpoint(s). Our clients range from small start- up companies to large, well- established companies in need of extra help and services. Our combined years of experience and expertise help them to streamline trial goal paths in order to achieve their product marketing approval, whether it is providing the initial or further expanding the marketing indications. We use current technologies and industry knowledge to help our clients to achieve their desired outcome.
6. How is the current economy hurting or helping recruitment?
The clinical research subject-recruiting environment is stronger than ever, as many subjects are aware of clinical trials and what it might mean to be part of one. The current economy does not seem to affect the subject population in clinical trial recruitment except for a subjects’ savvy in requesting travel reimbursement and other compensations.
However, the current economic situation is noticeably impacting venture capital funding and private investing for small companies trying to get their product into clinical trials. Patients seem to be eager to involve themselves in trial related therapies or treatment, however companies are limited on their payments related to trial related expenses due to the lack of adequate funding or strict control of trial budgets. It appears to be a “Catch 22” due to the investor demands asking for clinical data prior to funding release or approval. Most small startup companies need the money to start their trials and usually do not have prior human data beyond preclinical testing to support further investigation. Investors are requiring more human data in order to secure funding (more human data to help determine if this investment will have positive outcomes). This cripples the small startup company that is depending on funding for any clinical expense, especially those that are introducing novel technologies of therapy and treatment. In addition, governmental agencies are astute in requesting more safety data then they had in the past, thus trials are taking longer or are not starting as quickly as they did in the past. Public opinion continues to support the role of the governmental agencies to be the strong “ enforcer” in order to protect the subjects. Right or wrong, companies, whether large or small, must be smarter, more efficient, and have a precise strategy to achieve the goal to market, and recruitment is a secondary issue.
NaviGo Research, Inc. is a full service contract research organization providing clinical trial guidance and resources to the Medical Device, Pharmaceutical and Biotech industries. Our comprehensive expertise, integrated approach and unique ability to find creative solutions provide our clients the peace of mind that their trial is in good hands.
About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com
As the 20th Partnerships in Clinical Trials approaches next April, we wanted to you get to know the staff behind the event. Every two weeks, a Partnerships Team Member will share some of their memories and experiences with the event. Today, we have Andrew Sinetar, the Sales Manager of this year's event.
1) What do you do for Partnerships in Clinical Trials? How long have you been working on the Partnerships Event? I am the Sales Manager for the Conference. I work with our sponsorship and exhibit team to insure that we bring the maximum value to each of our supporters of the conference. I have been working on the Partnerships team for the past 10 years.
2) What is your favorite part of working on this event year after year? It has been incredibly rewarding to have seen the growth in size and stature of the conference. Over the year’s we have built strong relationships with many of our exhibitors and sponsors. I always look forward to seeing all the people and companies that have supported us for so long. The best feeling is when I hear how the conference helped secure new business for an exhibitor or sponsor.
3) Which conference has stood out in your mind and why? Who has been your favorite speaker at Partnerships? My personal favorite was back in 2008 at the Mandalay Bay in Las Vegas. We had a huge turnout in attendance and received great feedback from all. One of the highlight’s from that year was a presentation from Magic Johnson. He packed the room and had a very powerful and inspiring message.
4) What’s your favorite food? That’s an easy one – Being from NYC – Pizza. My least favorite food is any lunch offered by DIA!
5) What are you looking forward to the most for our 20th Anniversary? As always I am looking forward to seeing all our supporters. I am very much looking forward to seeing all of our new initiatives designed to increase exhibit hall traffic. I am definitely looking forward to seeing Foreigner, Thank You RPS!
India is top AIDS drug supplier, but its own poor can't afford it.Second-line treatment costs `4 - 6K per month. Yet, only a handful of patients are 'eligible' to get it for free. Even as India emerges as the leading supplier of AIDS medicines globally, patients in the country can barely afford their monthly treatments. India supplied over 80% of all AIDS medicines between 2002 and 2008 to four million people across African countries such as Congo, Mozambique, Tanzania, Kenya and Nigeria, and developing countries in South America, a recent study by the Journal of International AIDS Society revealed. http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=351
The Indian "role" for South Africa- As a part of the 'Brand India Promotion' project, Pharmexcil had organised four events that included meeting of African Ambassadors in India, high-level delegation to Africa Health Ministers Conference in Ethiopia, Trade delegation to Southern African countries and Indo-Africa Pharma Business who met at Hyderabad in September 2009 last year. The brand building programmes are part of the Indian government's aggressive campaign against the MNCs' propaganda against generic drugs in the African countries. It will be a major platform for the Indian pharma industry and the government to allay any fears among the African countries about the quality of Indian generic drugs. http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=240
Clearstone Central Laboratories recently posted an audio podcast on their website with Patrice Hugo, PhD (Chief Scientific Officer) speaking about his participation in a panel discussion at the recent IIR Central Labs East Conference in Boston.
At the conference, Patrice and other industry experts discussed best practices for choosing a central lab for oncology services. The panel also looked at the advantages and disadvantages of centralized and decentralized central lab models, as well as potential risk sharing strategies between sponsors and central labs for novel biomarker development.
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A Billion Dollar Boost
