Tuesday, March 21, 2017

'We need to do better job of defining patient-centricity' - Virgil Simons, founder The Prostate Net

For Virgil Simons, the patient is central to everything in drug development, which is hardly surprising for the founder and president of The Prostate Net and Prostate Net Europa - a 'non-profit patient education and advocacy organization dedicated to prostate cancer victims and their caregivers'.

Speaking at Partnerships in Clinical Trials Europe 2016, he explains that at the most basic level, the industry as a whole needs to do a 'better job of defining patient-centricity'. Through his work, Simons attempts to get the pharma industry to 'understand the role of patient-centricity from initial drug development, to clinical trial recruitment initiation, to downstream care. The problem is we talk a lot about it, but we don't really know how to do it.'

Friday, March 17, 2017

What does disruptive innovation mean to the clinical trials industry?

We asked many clinical trials professionals from pharma, CROs, academia, and non-profits about what disruptive innovation means to the clinical trials industry.

Hear these exclusive insights by watching the video below.

To learn more about what disruptive innovation holds for the clinical trials industry, join us at T3: Trials, Tech and Transformation in Orlando, FL this May. Save $200 with the VIP code T3BLOG17 | Click here to learn more.

Tuesday, March 14, 2017

What do clinical stakeholders need to think about when wanting to ‘do digital’?

ClinTech Month

The opportunities for organisations and stakeholders using digital technology such as mHealth in the clinical setting are growing rapidly. Products such as Apple ResearchKit, Health Kit and Google Fit, and Microsoft’s HealthVault are all providing wider access to valuable consumer health data gathered from a variety of sources, including wearables and hardware sensors.

This article explores what technologies exist to enable mobile applications to interact with cloud servers and how these technologies can be deployed.

Friday, March 10, 2017

The Primary Issues of Data Ownership

Big data has been one of the hottest buzzwords across all industries over the last few years and that doesn't seem to be changing anytime soon. Generally speaking, big data refers to large data sets that are to be analyzed to reveal patterns, trends, and associations that relate human behavior/interactions.

Pharma and biotech companies are not the first to this space and there is a lot that can be learned from other industries and those who have gone before, especially in regulated industries. William Tannenbaum, Co-Head of Technology Transactions Practice at Arent Fox LLP sat down with us to explore many of the major issues surrounding data ownership, best practices, privacy, and how the pharma/biotech industry can learn from other companies who have already been through this data revolution.

Watch the full interview with William Tannenbaum above to hear his perspective on these key issues and how they relate to our industry;
  • What can companies in pharma/biotech learn from companies in other industries regarding data practices?
  • Regarding data practices, what differentiates best practices from best-of-breed?
  • What are the primary issues around data ownership that companies need to consider? How should companies address these issues?
  • Privacy is obviously another key consideration. What are the issues here around privacy and what do companies need to think about?
At the upcoming T3: Trials, Tech and Transformation on May 11-12 in Orland, FL - The next wave of clinical innovation is one of the conference streams, where we will dive into clinical trials data management, analysis, and more. Register today and save up to $600 off standard rates with the VIP code T3BLOG17. Rates increase Friday, 3/17. Learn more here.

Wednesday, March 8, 2017

Women in pharma

International Women's Day

With the world celebrating International Women’s Day, we take a look at women in pharma.

Despite being set to become Big Pharma’s first female CEO, Emma Walmsley at GSK doesn’t see her gender as a major issue: ‘I’ve never primarily defined myself by my gender. I’ve been lucky enough to always work for companies or in countries where being female hasn’t limited or restricted me.’

However, the numbers suggest there is still some way to go before equality in pharma. Prior to Walmsley’s appointment, none of the world’s top 25 drugmakers were led by a woman, and less than 3% of new pharma CEO positions globally were given to women in 2015.

At Boston Biotech Week last year we spoke to President and CEO of Biomedical Growth Strategies Susan Windham-Bannister about the lack of gender diversity in Life Sciences and why organizations should be trying to improve.

Tuesday, March 7, 2017

9 questions that still need to be answered about technology in clinical trials

ClinTech Month

Over the last six months we have spoken to dozens of industry experts about every aspect of technology in clinical trials. One thing that has stood out is that there are more questions than answers around the tech revolution at the moment. Here we have gathered some of the biggest questions and how industry leaders are attempting to answer them.

1) Which technology platforms are most shaping the way trials are run? We asked four leaders from different areas of clinical research about the platforms they are most excited about - including Matthew Zachary, Founder/CEO of Stupid Cancer, and Dr David Fajgenbaum, Executive Director of Castleman Disease Collaborative Network.

2) Are clinical trials ready for mHealth adoption in 2017? Technological implementation has been slower than many had hoped for. Will 2017 be the breakthrough year for integration?

3) How is mobile health aiding patient-centricity? Sarah Iqbal from Biotaware explores how mHealth and wearables are making the patient experience in research more positive, helping to improve recruitment and retention.

Friday, March 3, 2017

Clinical Trials of the Future: The Impacts of mHealth & Big Data

ClinTech Month

Few disagree that technology will have a profound impact on the clinical trials of the future. However, which aspects of technology will play the biggest role and how best to integrate them is still very much up for debate. We asked three industry leaders about the technologies they are most excited by and the benefits they hope they'll bring.

Anna Matranga, MD at AMC Alliances & Consulting, admits that currently 'we're not very good at adopting technology and supporting that technology', and she hopes that as we move forward, the human-to-human relationship is not forgotten.

KCR CEO Mike Jagielski offers a CRO perspective and is most excited by partnerships and mergers that are 'combining healthcare data more thoroughly with the service industry in the clinical research execution space'.

Oliver Timmis, AKU Society CEO, sees a 'greater reliance on real world data instead of doing a Phase III or IV trials' as solving one of the biggest problems in rare disease research; unreliable access to treatment.

Watch the full interviews in the video above or here.

This post is part of ClinTech Month - explore more here

The Next Wave of Clinical Innovation is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register before 3/17 and save up to $400 off standard rates, PLUS use the exclusive code T3BLOG17 to save an additional $200. Find out more here.

Wednesday, March 1, 2017

ClinTech Month: The implementation, benefits & challenges of technology in clinical trials

ClinTech Month

Technology is revolutionising clinical trials, impacting every aspect of research, but whilst wide-ranging challenges remain, the speed of implementation is slower than many had hoped. All this month we are focusing on these issues, bringing you exclusive video interviews, reports, case studies and views as part of ClinTech Month.

We’ll be exploring the ways in which technology is having a profound impact, the benefits it is bringing and the obstacles that need to be cleared.

Types of tech

The numbers around mHealth and wearables are pretty staggering - estimates suggest that by 2020 there will be 25 billion connected devices, 4 million patients using remote monitoring technologies and the Internet of Medical Things industry worth $117 million. These are the building blocks of the technology revolution in clinical trials.

With a vast amount of new data being created, the cloud and Big Data analytics are becoming increasingly important, whilst Electronic Medical Records (EMRs) are getting more complex, faster and smoother. Additionally, online social networks are being used for recruitment and to connect patients to one another.

Monday, February 27, 2017

End of study patient surveys and the future of patient-centricity

Exclusive interview: Adama Ibrahim, Senior Clinical Operations Lead, Biogen

'We are working in an evolving ecosystem where we are either intentionally or without much choice having to change the way we work with patients.'

For Adama Ibrahim, Senior Clinical Operations Lead at Biogen, taking a more patient-centric approach to clinical trials is no longer a choice, but instead central to the future of the drug development industry; 'For us to be successful we need to make sure the patient experience is optimal and we need to be able to address problems.' She goes on to describe:
‘We're dealing with people here, we're not talking about machines, so we need to make sure that we treat them like human beings…Try to be more collaborative, try to listen more, but in a way that will actually affect the way we work, not just pay lip service.'

Friday, February 24, 2017

Is Patient-Centricity at the Core of Clinical Trials?

Recruitment and retention of study subjects in clinical research is at an all-time low; the average retention rate in 2013 was 33% which is a 56% drop from 2003 levels. Patient centricity has to do with making the patient feel special, and therefore clinical trial participation attractive as well as more valuable to them. More importantly, an attitude of patient centricity helps with continuity of care, better diagnostic targeting and treatment outcomes, and thus retention.

We had the pleasure of sitting down with five leading clinical trial professionals to discuss how well clinical trials currently treat patients and to what extent patient-centricity is truly at the core of research. In this conversation, we look at the ways in which clinical research can be made more patient-friendly to enhance recruitment and retention, including wearable technology, social media, novel trial designs, data management, support groups and sensitivity to minorities.

Thursday, February 23, 2017

Clinical technology survey 2017 - complete for a chance to win a 2-day pass

Technology is changing the way clinical trials are run faster than ever before. There’s a huge amount of excitement and investment in mHealth, cloud-based tech, Big Data and Electronic Medical Records, yet there are also concerns over regulations, training and cost.

We are conducting one of the biggest surveys of its kind across our database of over 50,000 clinical trial professionals from within pharma, CROs, academia and patient groups. The final report will reveal unique insights into how companies view the challenges and benefits of different aspects of clinical technology, and to what extent they are implementing them.

Win a 2-day pass…

Completing the survey will take just 5 minutes and will give you exclusive early access to the final report. Plus everyone who completes the survey by 5th March 2017 will be entered into a prize draw for a free 2-day conference pass to T3: Trials, Tech and Transformation in Orlando, Florida on 11-12 May 2017 or to Partnerships in Clinical Trials Europe in Amsterdam on 28-29 November 2017. Full terms and conditions can be found here.

We’re excited to see the results of this unique study and we hope you are too.

Friday, February 17, 2017

'I'm a very big critic of the current approach towards research subject information sheets' - Dr Kieran Doran, Senior Healthcare Ethics lecturer

Patients as Partners Month

Dr Kieran Doran, Senior Healthcare Ethics lecturer at University College Cork, argues that one of the biggest failings of patient-centricity in clinical trials currently is patient consent. The information on consent forms is too often in very technical detail, whilst additionally there's often a 'telephone directory's worth of information'. For Dr Doran this is a major issue when 'the very basic concept of informed consent is that the patient can understand, retain and comprehend the information being given to them.'

Watch the full interview with Dr Doran above, where he also explores the benefits of a standardized approach to clinical trials across Europe, and the challenges of patient data confidentiality.

This post is part of Patients as Partners Month - explore more here

Patient-centricity is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register today and save up to $1,000 off standard rates and use the exclusive code T3BLOG17 to save an additional $200. Rates increase Friday, 1/27. Find out more here.

Tuesday, February 14, 2017

How is mobile health aiding patient-centricity?

Patients as Partners Month

As healthcare extends its ‘institutional’ role and becomes more personal and mobile, patient-centricity is becoming a significant strategic focus for healthcare stakeholders. The Institute of Medicine defines patient-centricity as a means of providing care that is transparent, respectful of and responsive to individual patient preferences, needs and values, ensuring that patient values guide all clinical decisions.  In other words, being truly patient-centric means that healthcare decisions are shared between patient and clinician.

More than any other aspect of drug development, patients are at the centre of clinical trials. Research has demonstrated that putting the patient at the heart of a clinical study by engaging them throughout the process, leads to greater compliance of patients' at-home medical care and results in more successful studies for all involved.

Driving greater patient engagement empowers the patient to take an active role in the decisions made about their own healthcare and the frequency of self-management behaviors increases. This not only drives improved patient participation in a clinical study, but also lowers the burden on the site. This is particularly critical in the clinical trial context because patient engagement is synonymous with compliance, which is vital to the progression of the trial.

Friday, February 10, 2017

Where can clinical trials most improve in their approach to patient-centricity?

Patients as Partners Month

As part of Patients as Partners Month, we spoke to six leading figures from pharma, CROs, academia and patient groups about the current state of patient-centricity in clinical trials. How can those running trials improve the treatment of patients and how big a difference does it truly make to research results?

The speakers include:
  • - Dr Richard Thompson: Scientific Officer at Findacure
  • - Rob DiCicco: VP, Clinical Innovation and Digital Platforms at GSK & Transcelerate
  • - Mike Jagielski: CEO at KCR
  • - Anna Matranga: Managing Director at AMC Alliances & Consulting
  • - Dr Kieran Doran: Senior Healthcare Ethics Lecturer at University College Cork
  • - Virgil Simons: President at Prostate Net Europa

Wednesday, February 8, 2017

7 case studies of patient-centricity in clinical trials

Patients as Partners Month

Patient-centricity is one of those terms that connects to so many different aspects of clinical trials and yet is so often discussed in broad, theoretical terms. Over the last six months, we have spoken to dozens of drug development professionals leading the way in putting the patient at the centre of clinical research. Here we have gathered seven examples of how they're doing it and where they are succeeding.

1) Taking a patient centric approach to pediatric clinical trials: 'We have more than 20 years of experience with adult patients, but far more limited experience with children and young patients.' Patient Advocacy Manager at Sant Joan de Déu Children’s Hospital in Barcelona, Begonya Nafria Escalera, explores strategies that put the patient at the core of research.

Monday, February 6, 2017

Are patient-centric initiatives working in drug development?

Interview with Stella Stergiopoulos, Senior Project Manager at Tufts CSDD 

As Senior Project Manager at Tufts Center for the Study of Drug Development, Stella Stergiopoulos manages multi-sponsored and grant funded research projects. Having led a 2016 study on patient-centric initiatives, Stergiopoulos is uniquely placed to assess how well the drug development industry is currently working with patients and how successful new strategies are proving. As part of our Patients as Partners Month, we spoke to Stergiopoulos about the state of patient-centricity in clinical trials today.

Friday, February 3, 2017

INDUSTRY OVERVIEW: Patient-centricity in clinical trials today

Patients as Partners Month

For February, we will be shifting our topical focus from Niche Outsourcing to Patients as Partners. Over the course of the month we’ll be bringing you a range of interviews, videos and opinions on patient-centricity in clinical trial outsourcing, procurement, operations, and innovation. 

The clinical trials industry has come a long way from where is once was, but there is plenty of room for growth and improvement. Many industry professionals know nearly 80% of clinical trials fall short of their recruitment targets and that an estimated 30% of participants will drop out of a trial before its completion.

As an industry, there is a general understanding that an advanced commitment to patient-centricity will shape the future of this space. However, two questions first need to be asked: what does patient-centricity really mean? And is it truly at the core of clinical trials?

Friday, January 27, 2017

Conducting Clinical Research in Eastern Europe

With an over-saturation of the Western European market, there has recently been a shift towards conducting clinical trials in Eastern Europe - which now consists of roughly 20 countries. A majority of which are now part of the European Union, and this is big change compared to 10 or 15 years ago. The region has really become active in clinical trials and today, nearly 60% of the data for registering a product in Europe is coming out of Eastern Europe.

As a Clinical Operations Director at OptimaPharm, Nikola Strumberger has met many U.S. based companies in the recent years and always hears the same thing when discussing moving clinical operations to Eastern Europe: 'We are a conservative company with a conservative approach'. But looking at the data coming from this region; the quality of the data received and the increased number of sites should prove that there is no reason for companies to worry about conducting their clinical research in Eastern Europe.

Monday, January 23, 2017

‘For rare diseases, clinical trials are too expensive and take too long' - Fiona Lawrence, Director at Duchenne UK

Niche Outsourcing Month

This month we are focussing on niche parts of the clinical trials industry, including rare disease research.

As Director of Research and Clinical Development at Duchenne UK, Fiona Lawrence helps find and evaluate research projects that can contribute to fighting Duchenne Muscular Dystrophy. She has a particular focus on ‘projects that have the potential to accelerate the development of new treatments so making them available to patients as soon as possible’.

We spoke to Lawrence about the challenges and innovations impacting rare disease research today.

What are the biggest challenges of running clinical trials for a rare disease?

FL: ‘Duchenne Muscular Dystrophy is a relatively common rare disease, it is caused by a mutation in the gene located on the X chromosome that codes for the protein dystrophin and it occurs in approximately 1:3500 to 1:5000 live born boys and has the same incidence worldwide. The main challenge of running clinical trials for Duchenne is in the design of the trial. The inclusion criteria and endpoints need careful consideration in order not to be confounded by the natural history of the disease.’

Friday, January 20, 2017

How the AKU Society recruited 50% of their patient population in 9 months

Niche Outsourcing Month

'All of our work is about focusing on patient-centricity...and this makes our trials run very, very smoothly. ' For Oliver Timmis, CEO of patient group AKU Society, treating patients as partners isn't simply a box ticking exercise - it is the key to successful research.

Setting out to find a cure for the rare genetic disorder Alkaptonuria, Timmis and his team gained funding from the European Commission and formed partnerships with a CRO and pharmaceutical company to launch their own clinical trials. Even before the trials began, they worked with patients to make sure the design was suitable; 'from the start patient-centricity was key'.

Monday, January 16, 2017

Are clinical trials ready for mHealth adoption in 2017?

by Sarah Iqbal

The mHealth industry has been making a strong case for its ability to optimize clinical trials and improve engagement with patients. This time last year the Mobile Health in Clinical Trials Survey Report showed that while 80% of respondents believe the industry’s use of mHealth technology is still in its infancy, 60% consider it to be very important. Let’s recap on where we are and the efforts needed to progress in the coming year.

Where are we in the mHealth industry now?

Innovative use of mobile health information and sensing technologies has been integrated in various clinical studies to reduce cost and improve research outcomes. These technologies can support continuous health monitoring at both the individual and population level, streamline clinical trial processes, engage patients to be more responsive in clinical research and provide on-demand interventions in ways previously unimaginable. In addition, mHealth is most useful when it comes to improving data quality and patient trial adherence through gamification.

Friday, January 13, 2017

'The rare disease research field is ahead of other areas in patient engagement' - Dr Richard Thompson, Head of Research at Findacure

Niche Outsourcing Month

Whilst the challenges facing clinical research today are numerous, running trials for rare diseases brings with it a whole different set of  problems. We interviewed Dr Richard Thompson, a man who, as Head of Research at Findacure, knows this better than most.

Recruitment is the obvious barrier to rare disease trials:
'Because there are so few patients and split around the world, it can be very hard to identify and recruit them for trials. Patient groups that form nationally or internationally can give you access to that network very quickly, making recruitment a much easier process.'

Away from recruitment, the lack of knowledge about many rare diseases means that 'it can be hard to know exactly how the disease should progress and that makes it difficult to understand the landmarks or endpoints you are looking for in a trial'.

Monday, January 9, 2017

VIDEO: The biggest challenges and changes expected in clinical trials in 2017

Clinical trials are going through a period of great challenges and change at the moment as the industry grapples with technology adoption, patient recruitment and innovative partnerships. We asked a number of leading professionals from pharma, CROs, academia and charities about the biggest challenges they are currently facing and the changes they expect to see in 2017.

Technology inevitably came up time and time again, with an emphasis on adopting new tech in faster, more efficient ways. Anna Matranga, MD at AMC Alliances & Consulting, insists 'there needs to be some investment in bringing technology on board and trying to make it compatible with the systems we have in place.' Similarly, Oliver Timmis, CEO at AKU Society, sees a 'much bigger reliance on real world data' replacing Phase III or IV trials.

Wednesday, January 4, 2017

The 10 most popular posts of 2016

Throughout 2016 we covered all the hottest topics that impacted clinical trials during the year, from patient-centricity to wearables, and strategic partnerships to regulatory changes. Here we have gathered together the ten most popular posts we published last year.

1) Whitepaper: Are strategic partnerships in clinical trials living up to what they promised?
The most popular post of the year was our in-depth whitepaper exploring how and why strategic partnerships are developing in the 21st century, as well as the reasons behind current trends, the pros and cons of partnerships, and the impact of partnerships on drug development.

2) The 8 biggest challenges facing clinical trial professionals
Based on interviews we did with dozens of clinical professionals, we gathered together a report on the biggest challenges you faced last year.

Wednesday, December 28, 2016

What is the typical partnership in the 21st century?

Traditionally clinical trials were conducted in-house by pharmaceutical companies. The pressure of market and economic forces combined with the dynamic changes in clinical trial demographics and the increasing complexity of conducting trials has lead sponsors (pharmaceutical, biotech and medical device manufacturers) to outsource clinical trials to Contract Research Organizations (CROs).

At the onset a partnership between a Sponsor and a CRO meant that the sponsor outsourced the drug development to the CRO and provided them with the experimental drug as well as medical oversight. The CRO carried out all the administrative work on a clinical trial, recruited and trained participating researchers, co-ordinated the study process, provided study material and the drug being studied, collected data from various study sites and ensured that the researchers complied with clinical protocols.

In the 21st century partnerships have evolved from transactional, tactical, ‘fee-for-service’ arrangements with price as a dominating factor, to strategic partnerships where both profits and risks are shared, and core competence is the dominant factor. Strategic partnerships entail larger amount of work commitment, longer timelines, broader scopes and building infrastructure to support the entire product development cycle.

The above excerpt is from our recent whitepaper "Are Strategic Partnerships in Clinical Trials Living Up to What They Promised?". This paper describes how and why strategic partnerships are developing in the 21st century, elaborates on the reasons behind current trends, the pros and cons of the partnerships, impact of partnerships on drug development, ensuring the success of partnerships and future trends. Access the complete whitepaper here.