Clinical Trials 2020 trends, as told by #SCRS19
My most favorite part of my job is getting to hear directly from site personnel and patients about how clinical research impacts them. Last month, I had the opportunity to do just that at the 2019 Society for Clinical Research Sites (SCRS) Site Solutions Summit. During the event, four key insights emerged from among the various topics of discussion. These themes are indicative of the future as we head into 2020.
Theme 1: We need to bring new sites into research.
Of course the conference sessions were geared towards informing existing sites of best practices in clinical research. However, I was surprised to hear how many of these sessions leaned towards making the processes simpler in order to attract new doctors and sites into clinical research.
The complexity of clinical trials can be a barrier to recruiting and sustaining new research sites. Simplifying systems and processes is believed to be one of the answers to help bring more people into research. There are already not enough sites available to meet the current demand for clinical trials. Trials are only getting more complicated, so how do we adjust and bring in new sites and site staff? How do we add support while staying simple?
In addition to the complexity of clinical trials, the aging of the existing generation of researchers is also a concern. Collectively, we need to work towards an ecosystem that is attractive to a new generation of physicians that are interested in participating.
In addition to simplifying research processes, many other solutions are being identified to help with this problem. Research networks are one solution that can bring infrastructure and experienced staff into medical systems and physician practices in order to reduce the burden of investing in the staff, equipment, and facilities needed to get started in research. These networks then have access to additional physicians within the system that can be educated and recruited to participate in a variety of ways.
Another systematic solution that was discussed was how to relieve the tension between the physicians who might want to do research and the medical reimbursement systems which may be a disincentive for participating in research. Can we build a new incentive model that encourages research and highlights the value that clinical research can bring to patients?
Theme 2: De-Centralized trials are coming (slowly).
Virtual, De-Centralized, Home-based, Digital… There were a variety of names given to this next generation of trials. This new wave of trials promises to be more convenient for patients and to provide access to clinical trials for populations that may not be able to participate given their proximity to a physical clinical research site.
I was not surprised that De-Centralized trials were a hot topic of interest. However, I was surprised in how slowly these trials are being implemented. With all the excitement and interest in this topic, it is shocking that only 15% of sites reported having been approached with a trial with some element of virtualization. In general, there is still a lack of maturity and readiness to go digital, and clinical trials are still very manual, paper driven, and connected to a physical clinic.
When we imagined life in 2020, didn't we all think we were supposed to be living like the Jetsons by now, with flying cars and hyperbaric chambers that would fix all our ails?
It wasn’t all bad news, however. There are many disruptive tech companies trying to change things for the better. We saw a "Google Glass" type solution to do site qualification with remote monitoring (nobody needs to fly to a site!). There are also a variety of solutions for capturing patient data at home using devices that do not require a patient to visit the clinic and connecting via tele-web solutions to talk “live” with clinical research personnel. These solutions are just a few examples in which companies are helping to decentralize clinical trials and, in doing so, making them more accessible to more people.
One key moment for me came when a patient on a panel said: "Clinical research has to fit into your life." De-Centralized trials are one way we can help patients navigate the complexities of these trials.
Theme 3: Awareness of clinical trials is still low.
You can't participate in something that you don't know about. Awareness is the first hurdle. The good news is that SCRS19 had a panel of patients talking about the difficulties in clinical trials and their awareness of clinical trials.
Learning about clinical trials can be difficult to do and finding a clinical trial that may be right for a patient is even more difficult. At SCRS19, the conversation around awareness was really bubbling. People are starting to learn about clinical trials through the efforts we and others have done, but awareness has not "overflowed" yet. I did enjoy seeing a variety of solutions aimed at putting clinical research in front of patients and physicians at the point of care – really making clinical research a care option.
The ability to get clinical research in front of patients is at an all-time high with the tools we have. How do we find the difficult-to-find patient populations? How do we continue to improve resources for patients to download?
These are questions we aim to answer now, with an eye towards their impact on the future.
Theme 4: Relationships are key to success.
Like most things in life, people are key to the success of clinical trials. Forming strong relationships between the sponsor, the site, the CROs, and the various vendors is critical.
With the complexity of clinical trials come a lot of people in the mix, both at the site as well as the sponsor. There are people seeing patients, scheduling visits, running the labs, delivering the investigational product, running recruitment campaigns, and on and on… Clear communication and simplified accountabilities is important to keep everyone aligned.
One area we discussed at length was getting more site input up front when designing the clinical trials. How can we better partner with sites on solutions and get them involved up front in decision making? How can we better help sites plan for recruiting the patients, and how can we be helpful to them? Could local solutions be better, cheaper, and more effective? Can we fund and empower the sites to run their own campaigns? Our own CoDESIGN service is aimed to get this type of feedback from sites, but I think we can do even more to connect early with sites and understand their needs.
Patients have strong relationships with their primary care or specialist doctors. Leveraging those relationships can be a key to unlocking access to clinical trials for patients. We know from previous research that patients want to participate in a trial that their doctor is running or at least stay connected to their doctor throughout the trial. This brings us back to one of the earlier themes: How do we enable more doctors to participate in clinical research by running trials or create a referral network that keeps them connected to their patients during the study?
The future of clinical trials is exciting. We have a care option in clinical trials that patients want and need that has a very important place in the healthcare ecosystem. Focusing our efforts in these four key areas in 2020 and beyond will ensure that we continue to move research forward.