The Partnerships in Clinical Trials Blog focuses optimization intelligence, regulatory trends and globalization strategies for both as sponsors and CROs.It is an extension of the Partnerships in Clinical Trials Conference.
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We're taking some time off from our coverage of clinical trials to celebrate the season with our loved ones. We want to sincerely thank you for your readership, your comments and your participation. We look forward to returning to the world of clinical trials in 2011!
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 Michael Vidoni, one of the Business Development Managers for 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 started working with IIR in 2005 as a Business Development Manager and the 2011 event will be my 7th Partnerships in Clinical Trials.
2) What is your favorite part of working on this event year after year? What I like most about working on the Partnerships event, is working along side the great talents of the Partnerships team. In my 6 years working on Partnerships, I feel I have gained a great deal of knowledge and insight from my peers and especially enjoy working together to put on the best conference every year.
3) Which conference has stood out in your mind and why? I would have to say my first Partnerships event, which was in Dallas, TX in 2005. At the time, it seemed like a huge event and it is amazing to see how it has grown and evolved since then.
4) What’s your favorite food? It is tough to say just one, but Pizza and Wings are high on that list.
5) What are you looking forward to the most for our 20th Anniversary? I am looking forward to seeing everyone that I have worked with over the years as well as the many companies that are new to the conference.
So near but yet so far — could well describe the situation molecule-tweaking drug makers of India find themselves in. For years, they have been in the front and centre of the generics revolution — which is essentially about selling off-patent versions of expensive medicines invented by multinationals. While they remain good at the chemistry of molecular tweaking of patented drugs, they seem to have run into a high technology wall when trying to do the same with biologic medicines. Biosimilars — as off-patent biologics are called — are turning out to be a very closed opportunity for pharma firms that boast of a biotech products portfolio.
Industry estimates that by 2014, biologics worth $60 billion will go off patent in the US and Europe.That, experts say, is a massive opportunity for local companies such as Cipla, Biocon, Dr Reddy’s Laboratories and Lupin, which are in the process of developing biosimilars.
Recently posted interesting insights on the Veeda CR Corporate blog on are posted in the section titled Central Nervous System in blog titled:Generics "Glitter" or "Glittering" Generics
The debut segment of IIR’s new podcast series – “Inside Outsourcing: Spotlight on Clinical Trials” – has uncovered a happy disconnect between major sponsors and their CRO partners that may signal the end of a frustrating mindset common to clinical trial outsourcing partnerships.
CROs have long lamented Big Pharma’s reluctance to truly recognize the power of relationships.
But according to data from Avoca Group – a consultancy specializing in management of clinical trial partnerships – those days are over.
The problem is that apparently no one told the CROs!
In Part One of IIR’s four-part interview, Patty Leuchten, president and CEO of Avoca Group, shares some key learnings from Avoca's annual study on the state of the clinical outsourcing industry.
According to Leuchten, not only are big pharmas consolidating their spend withpreferred providers; they are investing in the quality of the relationships with CROs and they expect CROs to do the same – to devote particular time and attention to relationship management.
By contrast, CROs – who’ve always been highly vested in building relationships – have apparently not heard the good news and do not fully recognize that relationship management is becoming paramount in importance to their sponsors.
The findings seem to indicate a huge opportunity for CROs that are willing to 1) invest resources into structured relationship management programs and 2) dedicate more senior-level attention to their key client engagements.
Perhaps not surprisingly, Avoca also found a significant correlation between a sponsor’s investment in preferred partnerships and their perceived return on the investment.
Be sure to tune in to Part Two of our interview with Patty Leuchten, in which we’ll cover relationship dynamics in deeper detail and explore what sponsors are really looking for in a preferred CRO nowadays. We’ll also address common misconceptions about preferred provider relationships and look at some of the challenges facing biotechs and small pharma manufacturers.
Author’s notes: Patty Leuchten will moderate a panel of senior executives from Pfizer, Covance and Astellas on the topic of developing and maintaining efficiencies in CRO oversight at IIR’s Partnerships in Clinical Trials conference in Phoenix on Wednesday, March 30th.
AVOCA’s Denise Calaprice will also present a battery of key, preliminary findings from AVOCA’s 2011 industry report – an exclusive opportunity for Partnerships in Clinical Trials attendees!
For more information or to register for Partnerships in Clinical Trials – taking place March 30th thru April 1st in Phoenix, AZ – please visit www.iirusa.com/CROpartners
On a final note, Avoca is recruiting participants for their 2011 industry survey on the state of clinical outsourcing. To participate, please visit www.theavocagroup.com.
Participants will receive a complimentary executive summary of the results. The 2010 Avoca Report is also currently available for purchase on Avoca’s website.
Marc Dresner is an IIR communication lead with a background in trade journalism and marketing. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for market researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com
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 Start Up: Step 7 – Negotiating the CTA
This is the seventh 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
It is rare these days, for an original CTA template to be accepted, verbatim, by sites when they receive the first draft from the sponsor. This, in and of itself, is not a bad thing – quite the contrary: negotiation is a good thing, and when done properly the process should serve to meet the needs of all parties.
There are a multitude of complex and distinctly separate issues that arise when negotiating CTAs (e.g. indemnification, insurance, IP and publication rights, payment terms, etc.) and each of these topics merit their own discussion. Because of this, the scope of this article will cover the general concept of negotiation and not any specific clause or section of the CTA.
Preliminary actions to consider when approaching CTA negotiation include:
*Need identification
*Objective identification
*Scope of the problem
Speaking from Experience…
Dan Manak has negotiated over 1,000 CTAs and can count on one hand the number of instances in which mutually agreeable terms eluded him. In no instance did any of these agreements undergo legal challenge or law suits. In most cases, when it appears there is no middle ground it is because one or more parties either do not know their limitations or they do not accurately convey them up front. If you reach an apparent dead-end, do not give up hope before escalating as much as you need to with the parties with whom you are negotiating.
Often times, the sponsor or CRO person with whom a site is initially negotiating can only do so much in terms of altering their standard agreement. This does not mean that alternative terms are unavailable, but it may require more leg work to get to the right people that can help find that middle ground. Whether or not escalation is called for, never lose your poise or professionalism, or let the negotiation turn into an argument. Keep in mind that you would not be in negotiations in the first place if all parties did not want the same thing – a fully executed agreement outlining mutual involvement in the trial.
Helpful Tips
Part of the planning and preparing process is to define and rank priority interests. The key here is to understand that these negotiations are based on different interests of the different parties and the likely result will be concessions regarding these interests. Make certain that you are trading items or issues of less importance in order to gain substance of greater importance.
Access the priorities of the other parties. The better you understand the other perspectives, the greater likelihood of successful outcomes through negotiation. This may involve some guess work on your part; hopefully they are educated guesses. This exercise alone will foster thought and ideas regarding conflict resolution. As we don the shoes of the people across the negotiating table, our minds will begin to creatively think of possible solutions, while considering the other party’s respective positions.
If you are a site and have had to pass on multiple contracts due to a single internal policy, it may be a good idea to have a full review of that policy. For example, Dan has worked with sites that had such stringent insurance requirements they were precluded from most trials. The solution may be to find an alternate provider. When it comes to payment terms and monetary reimbursement – if suitable terms are not met; the best choice may be to walk away, rather than accept a contract which would be financially unreasonable for your site to perform. A win-win scenario is what everyone is shooting for and there is no ‘win’ if your site will lose money to perform a trial. Always make sure you are well-educated on the subject matter, persistent in your follow up, and courteous and professional in every respect.
In Closing…
“We cannot negotiate with those who say, “What’s mine is mine and what’s yours is negotiable.””… “Let us never negotiate out of fear. But, let us never fear to negotiate.” -JFKAllan 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
Dan Heath Innovation, Strategy, Marketing, Branding, Change Management, Communication
If there is something that characterizes the pharmaceutical environment today it is change. Whether it is because of new products, partnership models, delivery methods, technology, or the global economic landscape, pharmaceutical companies must be ready to learn new ways of doing things.
Your management of change is critical to the success of your company.
Why is it so hard to make lasting changes in your company? How do you get people to start behaving in a new way?
Join Dan Heath, Senior Fellow at Duke University's CASE center and co-author of Switch: How to Change Things When Change Is Hard, as he challenges the way you think about the framework need to create change. Dan will be drawing on case studies and decades of scientific research to help executives in the biopharmaceutical industry learn how to take small steps needed to create big changes.
Dan Heath will be presenting the keynote presentation, "Create and Manage Transformational Change – How Do We Make the Switch?" on Thursday, March 31, 2011 at the 20th Annual Partnerships in Clinical Trials Conference. He will explore a pattern in successful changes that you can apply to identify the critical moves needed to spark movement in a new direction. Download the conference brochure to find out more about his presentation and the rest of the agenda.
Dan previously co-wrote the critically acclaimed book Made to Stick, which was named the Best Business Book of the Year, spent 24 months on the BusinessWeek bestseller list, and was translated into 29 languages. The book explores why some ideas survive and others die to help transform the way you communicate ideas in order to make messages stick.
India's pharmaceutical industry exports cheap generics to many countries in Africa and Latin America. Generics are copies of drugs that no longer enjoy patent protection.
Some of the generics exported by India continue to enjoy patent protection in the European Union. The Customs authorities of some of these countries have therefore confiscated the consignment of such drugs on the way to other countries through European ports for violating their intellectual property rights.
The seizures took place following complaints by pharmaceutical giants holding patents to the medicines in Europe including Sanofi-Aventis SA , Novartis AG and Eli Lilly & Co. This had created uncertainty for India's Rs 40,000 crore generics export industry following at least 17 cases of seizures of consignments in the Netherlands, Germany and France over the last two years.
India protested strongly against the confiscations, which it termed illegal, as the generics were off patent in India and were not meant for sale in the EU. It also raised humanitarian concerns, arguing that countries in Africa and Latin America do not have the capability to manufacture these life-saving medicines and cannot afford the patented alternatives.
India even took the issue to the World Trade Organization (WTO), arguing that the seizures amounted to violation of the international intellectual property agreement, Trips, and asked the EU for consultations.
Share you opinion in the next Partnerships in Clinical Trials poll! We want to make the Partnerships in Clinical Trials an interactive, online network for you! Through our online Partnerships network, we have monthly polls for you to participate in. You can vote by visiting any of these sites in the Partnerships network: Partnerships in Clinical Trials blog, @PartnershipCROs Twitter, and our Partnerships with CROs LinkedIn group. The current poll closes in two weeks!
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: “Successful Leadership in Managing Sponsor and CRO Interactions
This week’s contribution to ’52 Perspectives’ comes to us from Johan Reinhoudt, the President and Principal Consultant of Collaborative Primacy Life Sciences Consulting. Johan is a practical business visionary with deep industry knowledge through more than two decades of experience in the healthcare and life sciences industries with demonstrated success in global executive leadership roles.
What impact does effective leadership have specifically in the interactions between a sponsor and a CRO?
It is the leadership’s role to clearly define for the organization the information and the details for the Request For Proposal and the subsequent Work Order (contract). It is important that the information be provided in a timely fashion and strategies should not change at mid-course. Otherwise huge costs have to be incurred for “change orders” and delays are highly likely.
Many organizations use the ‘dynamic’ life sciences drug development environment as an excuse to continuously change course, without a clear strategic reasoning. Usually this is more related to the inability to define what needs to be done, than to the necessity to change course based upon recent generated data.
A successful project with a CRO is clearly defined by leadership right from the start. It is also well managed i.e., excellent time, quality, human and fiscal resources and output oversight by both the CRO and the sponsor’s leadership. An outsourced project depends largely upon the specific staff that is allocated by the CRO. When leaders outsource, they factually in-source, they buy a team of resources. To ensure successful completion, the sponsor leader must ensure that the staff within the allocated team are well experienced, knows site and study management and have the right level of communication skills to manage this type of inter-action. In addition, the leader is required to have a clear definition of the contract and pay upon receipt of deliverables (milestones), directed by the project plan.
The leader will require regular operational and senior management meetings to keep in touch with the CRO organization and ensure on budget and within the projected time frame project completion.
Leaders who successfully manage Sponsor – CRO relationships, understand the collaborative nature, fundamental to a successful outcome. Using a CRO, does not allow for uncontrolled and unprofessional sponsor internal work, to be ‘fixed’ by the CRO. The collaborative partnership established by leadership needs to be modeled after the leader’s behaviors, hence will be visible in the team’s operational approach and project management.
About Collaborative Primacy Life Sciences Consulting: CPLS Consulting is a specialized management-consulting, leadership and innovation capability development firm, with a primary focus on the biotechnology, medical device and pharmaceutical industry. When business leaders need professional assistance for challenges facing their enterprise, they call on us – a collaborative, responsive and strategic partner focused on their industry and their needs.We strive to be the innovative source of the next generation life sciences consulting, maximizing client value through leadership development.To contact Johan, please Click Here
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 Megan Antonelli, the Managing Director 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 started with IIR in 1998 as a conference producer and became Managing Director of the Pharmaceutical Division in 2008. In this role, I work with the team to deliver provocative and compelling content and unparalleled networking at all of our events. This of course includes working closely with the team on Partnerships in Clinical Trials, the largest event in our portfolio.
2) What is your favorite part of working on this event year after year? Each year, we create the event from scratch. To keep the content fresh and ensure that the networking can’t be compared to any other event in the space, we have to approach the event with a fresh perspective every year and speak to brand new people in the market. I love working with all of the advisors and experts to shape the new program which new experiences and new perspectives.
3) Which conference has stood out in your mind and why? Who has been your favorite speaker at Partnerships? Last year’s event was second to none and the speakers as usual were phenomenal. However, I have to say Ethan Zohn really put everything in perspective by sharing his story as a Cancer survivor. There wasn’t a dry eye in the house. I’m also a bit of a healthcare IT geek so Chris Anderson’s look at how technology will shape clinical trials and how consumers will interact with their health data was also great. I can’t wait to hear Tom Goetz this year as he takes this discussion to the next level this year.
4) What’s your favorite food? Well I’m pregnant so I’m not sure we have the room.
5) What are you looking forward to the most for our 20th Anniversary? I can’t wait to see all of the hard work of our team, advisors, sponsors and speakers come together. There are so many great sessions including Emerging Markets Jeopardy with Bob Eubanks and Dan Heath’s talk on Change Management. Also I’ve seen Vijay Govindarajan speak before and he is just brilliant. Really there is no way I could pick just one so I have to go with….the whole thing!
“Pay-For-Delay” deals between Big Pharma and generic drug makers has been going on for years.
The EU Commission’s latest raids happened this week and focused on AstraZeneca’s top-selling heartburn and ulcer drug Nexium. The U.K.’s second-biggest drug maker had a number of its sites in Europe raided, while Switzerland-based Nycomed said two of its sites in Germany received visits. One source said the raids were related. It joins other antitrust investigations that EU regulators are conducting involving generics deals made by GlaxoSmithKline, Teva Pharmaceutical Industries, and other big-name drugmakers. Such raids focus on Pay-For-Delay settlements, where brand-name drug firms pay a potential generic competitor to abandon a patent challenge and delay entering the market. The practice is controversial and opaque as details rarely come to light unless exposed by regulators.
The U.S. Federal Trade Commission has repeatedly condemned Pay-For-Delay deals on grounds they keep lower-cost generics off the market, costing taxpayers and governments billions.
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: Mark A. Lanfear, Vice President, Worldwide Strategic Alliances, KFORCE CLINICAL RESEARCH, INC. Katie Margules, BS, MSc, Senior Director, Project Management, Latin America, Clinical Development Services, COVANCE INC Jacqueline Mardell, Formerly Senior Director of Clinical Operations, METABOLEX INC. Nagaraja Srivatsan, VP & Head of Life Sciences, North America, COGNIZANT TECHNOLOGY SOLUTIONS
Presentations were given by four panel members that covered all aspects of conducting clinical trials in emerging countries/regions. The specific regions discussed were Russia, Latin America and India. These detailed discussions included regulatory and ethical considerations when conducting studies in these parts of the world. The key points for each region is as discussed below.
Russia
The approval process in Russia includes both the ethical as well as the regulatory component that is sent to the Ministry of Health, State Pharmacological Committee.
Russia is attractive as a region to conduct clinical studies as there are 11 cities with from 1 to 10 million people with a significant number of patients for treatment purposes.
There have been Federal Laws that have been enacted in 7/93, 6/98, 12/98 and 6/03 that specifically discuss the Rules for Clinical Research.
Sponsors are going to Russia due to lower costs and readily available patients.
FDA results are good in Russia with respect to compliance issues.
Study start up times are comparable to US and other countries where the quality is good. Georgia is an emerging market for clinical trials and interested parties are encouraged to initiate these studies in this region sooner rather than later. A caveat to consider is that the approval process can be slow in Russia.
Latin America (LA)
The major markets in LA are Brazil, Mexico, Colombia, Argentina, Peru, Chile (17-190 million) Guatemala, Dom Republic, Nicaragua, Costa Rica, Panama Puerto Rico (4 – 13 Million).
There are numerous special populations for specific diseases in Central America as well as experienced key opinion leaders (KOL).
Advantages I -Conducting clinical trials in LA
Populations are concentrated in fewer and larger cities than US or Europe.
There are primarily two languages in LA and they are, Portuguese and Spanish.
There is a shorter development process of drugs treating seasonal diseases in LA. There can be a higher incidence of some diseases in some countries and one can have better access to naïve patient populations.
There are fewer competitive trials within a given country in LA.
Monitor’s academic credentials equal or better than in US or Europe.
Advantages II – Patients willing to participate in clinical trials
Frequent and easier communication between sites and monitors
Investigators eager to participate in clinical trials
Provides alternatives for financial support
Critical Success Factors – Sponsors are encouraged to speak with regulators frequently, to get a commitment from each country to work with sponsors and to implement what is needed to meet guidelines and changing environments.
Each country has unique cultures, doctor patient relationship, healthcare systems, standard of care, increased monitoring frequency and communication.
Critical Success Factors II – Numerous activities need to occur in order to be successful in LA. Among them are to have a clear development strategy (study designs), address issues associated with the importation of clinical supplies early in the process, obtaining the appropriate licenses, translations of key documents in the local language and addressing required safety reporting standards.
Some countries in the LA region may suffer from social, economical political unrest during clinical study. One needs to be diligent in knowing the cultural, social and political issues in the countries of interest.
LA has done about 5000 clinical trials BAM countries (Brazil, Argentina and Mexico) comprise the majority of activity (about 2600 trials combined).
Therapeutic areas (major) in LA include CNS, ID, Oncology, CV .
The LA regulatory process averages between 4 to 8 months.
FDA inspections are on par with other parts of the world with respect to compliance issues.
India
Sponsor Considerations – 2015, India is expecting a significant increase in patient population across most therapeutic areas. India has lower drop put rates and failures in screening of study subjects.
There is huge growth in good health care infrastructure Tier 1 cities with lesser growth in Tier II and III cities.
Cost Competitiveness – Only one of many factors to consider when placing a clinical trial. To date, India is the least expensive country to conduct clinical trials.
Clinical trial experience in India is very good. Relatively inexperienced as a country with the conduct of clinical studies but quality is very good. The share of global trials is expected to double in the coming years.
Sponsor Considerations –
Companies are establishing an Indian presence where it makes financial sense. Many companies are moving towards partnering in country. Leverage for global companies by having local presence.
Key factors – cost effective, rich genetic diversity, quick patient recruitment, English speaking Inv./Doctors, inherent advantage in IT skills & study set up, data management statistical programming.
Challenges – Only parts of clinical devlopment are outsourced, regulatory approvals takes about 90 days, The Drug Controller General of India (DCGI) is reluctant to approve FTIM studies to be done in India, there is a shortage of GCP trained investigators.
Supplier and Market Considerations- Breaking up a clinical trial into input/process/output would allow a sponsor to define a global strategy by utilizing different delivery locations for each activity which allows for flexibility in conducting. This approach also allows for flexibility in the distribution of work across different vendors.
Key points for setting up trials on a global basis – Multi-Sourcing strategy (clear strategy, cost benefits thru vendor competition, multiple vendors, scalability), get the right multi-sourcing tools (vendors performance management, service agreements, performance indicators, benchmarks, governance models, mutual beneficial agreements), promote innovation (push vendors to improve efficiency and satisfaction while driving costs down, create culture to generate new ideas.
Risks
Lack of appropriate knowledge transfer
Incomplete documentation
Communication
Inaccurate volumes projections
Infrastructure & Technology Issues
Staffing Gaps
Suggested Metrics for Clinical Operations Know what needs to be done when, best practice, benchmarks
Governance – Need monthly meetings to keep on top of all issues, daily/weekly status reviews and quarterly reviews are appropriate.
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 Start Up: Step 6 – The Clinical Trial Agreement (CTA)
This is the sixth 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!
The Clinical Trial Agreement (CTA):
This document which can go by other names, like any other document processed in the clinical trial start-up process, is mandatory and often proves to be responsible for substantial delays in site activation measured in days, weeks, or months.
The CTA is a legal binding agreement between the sponsor and the institution; whereas the sponsor typically provides the study drug or device, financial support, and proprietary information; and the institution provides data and results, publication or input into publication, and potential further intellectual property. The CTA achieves important functions between sponsor and site such as: allocation of: risk, responsibilities, obligations, and financial commitments. It also serves to protect both parties with regard to academic, legal, and intellectual property rights.
Typical sections of the CTA are: * Preamble * Acknowledgements & Responsibilities * Term & Termination * Payment/Reimbursement of Costs * HIPAA, Patient Privacy * Publication * Intellectual Property * Confidentiality/ * Proprietary Information * Indemnification * Insurance * Subject Injury * Waiver of Consequential Damages * Miscellaneous o Export Controls o Governing Law o Dispute Resolution/ Arbitration/Mediation * Exhibits (e.g. budget & payment terms)
Executing the CTA
The CTA will almost always include the sponsor and institution/site, and may also include a CRO as a third party; in which case the document will outline the same parameters for CRO involvement. Since ultimate responsibility at the institution rests on the principal investigator, it is almost always the case that the PI must sign the CTA.
Sponsors have template CTAs that they use with every site, though they may have different templates for different kinds of institutions with which they may work (independent research site, academic institution, site network, etc). The contracting process begins when the site receives the template contract from the sponsor. Following institutional review of the CTA template, one of two things may happen. They may either sign and return it to the sponsor for full execution, or they may redline their requested changes and return the edited version to the sponsor for approval.
Hurdles
As one can surmise by looking at the contents of a CTA, there are many potential points of contention outlined within this document, with indemnification, insurance, intellectual property, and budget being some of the hot spots. Again, each topic within the CTA merits its own study and the purpose of this blog will be to look at the bigger picture of road blocks and remedies in the CTA execution process.
Both parties (or all three if a CRO is also included) may present limiting factors in efficiently executing the CTA.
Beginning from when the CTA is first generated, most sites will want to see the budget and CTA prior to completing the regulatory package for the IRB. It is reasonable for the institution/site to want to confirm that the study will be equitable for them. Typically, sites are not compensated throughout the start-up process, so completion of regulatory work before they are certain they will be working on the study (i.e. they can afford to), would be a marked misuse of resources. Oftentimes; however, due to internal sponsor or CRO SOPs, the budget, CTA and regulatory pack are all delivered simultaneously. It is not uncommon for the CTA and budget to follow the regulatory pack weeks later.
Poor delivery of the CTA can include ill-thought out timing as discussed above, but the delivery method can also impede efficient CTA processing. The sponsor that sends the regulatory pack with 3 hard copies of executable CTAs when first delivering the CTA is making a big presumption – that is that the site will approve the language within the CTA as is, sign, and return all three copies. While it is still common place for sites to accept the initial language in the CTA as well as the budget offered, it’s baffling why so many variables within these documents are negotiable and site or state or country specific.
It would behoove all parties if the CTA was delivered in an editable, electronic format from the person with whom negotiations will eventually take place. Ideally, this would be done immediately after the site has been approved for initiation. Truthfully, it does not hurt to send them even earlier in the start-up process. It is not uncommon for sites to forgo initiation due to an inability to come to mutually acceptable terms in the budget or CTA. If delivery is done prior to the pre-study visit, and the site does not agree to the terms, at least the early identification of this eventuality will minimize the loss of dollars and time spent by the sponsor &/or CRO in the start-up process. Furthermore; recognizing the site’s need to negotiate these documents and facilitating that process for them will assure that sponsor and CRO teams have done what they can to minimize delays due to contracting.
Tips: * The site will be at a disadvantage if they have not spent adequate time and resources in developing their own internal CTA/budget SOPs and trainings. * Knowing well what the guidelines and restrictions are for your state and site will service sites well when red-lining the sponsor’s template * Basic negotiation skills are essential for the sites to facilitate an efficient completion of the CTA * A phone call, in tandem to the email with the edited CTA is a nice touch and helps pave the way for successful negotiations * Basic preparation such as having an up-to-date insurance policy to share should the sponsor require verification * 48-72 hours is a reasonable expectation in turnaround time for the first red-line draft to be delivered
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
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