In this exclusive interview Dr. Raphaela Schnurbus, Clinical Solutions Director at CRO OPIS, discusses how partnerships in clinical trials are evolving and the challenges that still need to be overcome, as well as the future of trial design.
Where do you see differing goals between Sponsors, CROs, patients and investigators? What issues does that cause?
It is obvious that there are differing goals simply due to the fact that we are mixing industries, public and private businesses, payers, profit makers and people/patients with often very different needs and issues due to the characteristics of their disease. I think that advancement of medical science for the benefit of people suffering from disease is something we all have in common but Sponsors/pharma, service providers, researchers and end-users/patients play such different roles in this enormously complex process that establishing common goals at all stages of the cycle, is almost impossible.
Unfortunately, when goals are translated into cost, staying within budgets and finding funding, there are still difficult issues with technologies and tools that aim to bring together all stakeholders for the full benefit of patients. These solutions require additional investment, but I do however see changes in collaboration or partnerships among players and some very inspiring situations are emerging.
Looking to the future how do you think these partnerships will evolve? How will that help optimize trials?
I would like to start from what is already happening. Compared to 10 years ago, pharma companies have really made an effort to be more transparent and are more willing to share research data. Researchers share data through therapeutic specific platforms, have access to, and possibilities to comment on, publications. Academic institutions have formed closer partnerships with healthcare institutions, and non-profit organizations and patient associations are very active in spreading information about latest R&D, development, trials and support to communities who participate with amazing initiatives.
Forming consortia is definitely the future and having looked at a few of the existing ones around, I have to say that interesting business models are emerging and in my opinion, participation towards achieving common goals are getting a step closer. A big advantage of such collaboration is the optimization of patient participation in trials. Having all stakeholders under one umbrella and establishing a model that clearly benefits all is wonderfully exciting.
Where do you see the future of trial design? How do you think it will change in the next two years? Next ten years?
It is clear that patient-centric trial design is here to stay. The FDA has already released several draft guidance documents to favor a patient-centric approach.
When it comes to designing processes for modern trial execution, Artificial Intelligence has the potential to streamline these processes, from matching eligible patients to studies, to medication adherence and data collection. Again, the FDA is definitely helping with guidance that lay the groundwork for advancements in digital health.
Virtual trials and decentralized trials are already a reality in the US. Pragmatic trials, basket trials and umbrella trials are the future. With precision and personalized medicine, patient selection for trials have become very specialized. As a result, “wasting” patients on control groups in trials will have to be replaced by smarter options such as randomizing against real world patient data.
In 10 years? Who knows. Would the gold standard RCT (randomized controlled trials) and the enormous multi-country phase III trials still exist as we know them today? I guess it depends on how smartly we start to use the enormous quantity of data we are generating and how preciously we view patient contribution in medical research.
Collaboration, trial design and new technologies are some of the key topics at Partnerships in Clinical Trials Europe in Barcelona on 27 - 29 November 2018. Explore the full agenda or register for a pass.