Clinical trials are quite a complex undertaking to say the least. There are the sites to establish, the principal investigators to hire, the patients to recruit, the protocol to follow, interactions between the trial sponsor and regulators. And even when all the work is done as expected, the principal investigators frequently face challenges in getting paid on time, even after dealing with arduous contract negotiations in the first place. All of that contributes to the annual 40 percent turnover rate for these site investigators, according to a new study by Tufts Center for the Study of Drug Development.
The fundamental problem, said Kenneth Getz, the director of sponsored programs for the Tufts Center, is the needlessly complicated design of clinical trials shaped by complex regulatory requirements from the U.S. Food and Drug Administration. Protocol design is an area the center has focused on for the past 10 years, according to Getz.
Other factors cited in the study that have an impact on turnover is the continued trend away from North American principal investigators in favor of regions like South America and Asia. There has also been a shift from using principal investors associated with academic research centers to independent, community-based investigators. At 27,294, the number of principal investigators participating in FDA-regulated studies is at an all-time high, according to the study. The reason is rising clinical trial volume coupled with each site conducting fewer trials.
Various groups have formed to address the problem like Transcelerate and accreditation group, the Alliance for Clinical Research Excellence and Safety. Today ACRES, which launched a Site Accreditation Standards Initiative in December, said in a press release that it has appointed to co-chairs of the initiative’s steering committee Linda Meyerson, who retired as chief operating officer at Icon CR, a Philadelphia-based pharmaceutical services company, and Tracy Harmon Blumenfeld, the co-founder, president and CEO of RapidTrials, to improve clinical trial efficiency. But movement has been slow. Meanwhile, there are 4,000 to 6,000 active trials going on at any one time, Getz estimates.
A number of companies and startups have taken innovative approaches to help principal investigators. Earlier this year, New York-based Transparency Life Sciences got approval from the FDA to proceed with the first clinical trial, which had a crowdsourced trial design. Other companies have sought to make clinical trials more efficient with tools to improve communication to minimize duplication and paperwork such as Philadelphia-based myClin led by founder James Denmark. DrugDev, a UK company with U.S. headquarters in Princeton, New Jersey, uses a network of more than 67,000 independently rated investigators to help clinical teams set up sites faster by collecting relevant documents in each region in advance. CTB Solutions’ Synsource software program integrate clinical operational data and financial data to give a real-time view of how much the study will cost and how long it will take.
But while these innovations are helpful they are not addressing the root causes of the problem, Getz says. “They are point solutions — they touch on areas downstream, but don’t touch on root causes like regulatory burden and performance inefficiencies, and it is that protocol or blueprint that needs to be improved.”