According to Kenneth Getz, the Deputy Director of the Tufts Center for the Study of Drug Development (CSDD), “It can be quite challenging to imagine what the future might look like while we are still living in a fluid and changing environment.” However, by looking at the world of drug development prior to the pandemic, we can understand our responses to the crisis and have a framework that can guide our predictions about the future.
Over the past 10 years, the CSDD has been monitoring clinical research characteristics and Getz points out four main trends.
1. Study designs are becoming increasingly complex
According to Getz, the clinical trial complexity is related to the number of study procedures, endpoints, methods of data collection and patients that need to be randomized. Overall, there has been a drastic increase in all areas, except for the required number of randomized participants (as studies are targeting uncommon diseases), and indicates that designs are only becoming more complex with time.
2. The clinical research industry is fragmented
Historically, the industry has been composed of individual organizations working to achieve their own goals and this has led to difficulties in directing and coordinating research efforts.
3. There is currently mixed public and patient engagement in clinical research
Typically, patients will express high willingness to get involved in research (roughly 84% in a CSDD survey), but this does not translate into actual participation. Due to the discrepancy between willingness and actual participation, enrollment periods must be increased by 94% to achieve target enrollment levels. The same survey revealed that nearly 60% choose not to enroll due to the amount of procedures that studies require. Getz also notes that racial and ethnic disparities still exist within clinical research.
4. The clinical trial industry is highly risk averse
Because the industry as a whole is highly risk averse, we are frequently stuck in piloting mode and have created a barrier to progress in clinical research. Most notably, 84% of sponsor companies have indicated that they are unlikely to adopt new solutions without pilot studies or proof of concept. As a result, failure to achieve drug approval is at an all time high.
Clinical research can be divided into three areas: Planning & design, clinical trial execution and data analysis & reporting. While COVID has affected all areas of clinical research, clinical trial execution has suffered the most impact (i.e., delays to trial starts, enrollment holds, interruptions to supply chains, lack of access to data and travel restrictions).
In response to these challenges, there has been a dramatic increase in…
- Communication between industry players (research sites, clinical research organizations, sponsors, IRBs, FDA)
- Use of simulations and modeling to make well-informed decisions
- Adoption of technologies for virtual visits, data collection and limited forms of remote monitoring
- Flexibility from regulatory authorities including the FDA and IRBs
By reflecting on historical trends in clinical research and identifying what we have learned during the pandemic, Getz says we can form a picture of drug development in the future. He also remains optimistic that the changes will be for the long term.
So, what does clinical research look like in the future?
1. Study protocols will have even greater scientific and operative complexity
2. The research community will be less fragmented and more collaborative
3. Study participation will increase because trials will adopt hybrid models (a combination of virtual and in person visits) and move away from site centered trials, effectively increasing options for participants
4. CROs and sponsors will be more open to challenging and modifying the typical trial model. Regulatory authorities will be more flexible and communicative.
- Kenneth Getz, Deputy Director and Professor at the Tufts Center for the Study of Drug Development at Tufts University School of Medicine; Founder and Chairman of CISCRP; Member of the WCG Board of Advisors
- Lindsay McNair, Chief Medical Officer of WCG (Moderator)
To hear more from Kenneth Getz, watch WCG’s full webinar on the future of clinical research.