One of the largest vendors providing regulatory review solutions, research quality, compliance consulting services, and clinical site technologies, recently shared the publication of The State of Clinical Trial Activation at Sites, a report providing actionable solutions to streamline study activation and maximize operational efficiency. The report is based on a survey Advarra conducted in late 2020. Industry data suggest that it can take over 180 days to activate a clinical research study, and the process continues to get longer. The longer it takes for a new therapy to reach the market, the more time and resources research sites use, and these delays potentially hinder their chances of being selected for future trials. Additionally, sponsors are trying to solve mission-critical challenges to bring life-changing therapies to patients faster. In the meantime, the site world faces growing pressures, from competitive forces due to consolidation to growing demands for investment in sophisticated technology infrastructure.
The Advarra Trial Site Survey
In an attempt to learn more about study activation challenges, Advarra surveyed clinical research professionals from academic and commercial sites. In the survey, clinical research site professionals examined the industry’s current study activation process and identified key processes it impacts and associated resource constraints.
- 35% of survey respondents reported activation timelines of 91 days or more.
- Only 19% indicated their study activation process is completed in 30 days or less.
- Investigative sites (including independent, private practice, and dedicated research sites) were more likely to report shorter activation timelines (80% reported 60 days or fewer) than hospital/health system-based sites (34%) or AMCs and universities (21%).
Five Key Success Factors Mentioned but Not Disclosed
The report illustrates five key success factors affecting study activation and suggests solutions to sites wanting to improve their study activation process. While activation timelines have continued to lengthen, hindering protocol startup goals, there are tactics sites can implement that will help make protocol activation more efficient.
“Through this survey, we were able to identify specific pain points sites face during study activation,” said Dr. Wendy Tate, Director of Research Operations at Advarra. “This report gives researchers a bird’s-eye view of trends in the industry and provides specific ways to improve study activation at the site level. By leveraging the right resources, sites can find efficiencies in a connected clinical trial ecosystem to perform safer, smarter, faster research.
But Do Sites Feel Pressure from Sponsors?
TrialSite has reported several sites contacting the site-oriented media and engagement platform to discuss the state of affairs between sponsors and trial sites. Of course, contract research organizations (CROs) do much of the operational lifting during a clinical trial and often the CROs must crank work out at breakneck speed due to competitive commitment in the request for proposal process.
With the onset of the COVID-19 pandemic sponsors and their CRO vendors have stepped up the pace in moving toward more agile and accelerated models of clinical research delivery, from embrace of various technologies and processes when and where feasible.
TrialSite has chronicled over the past couple years since launching the trend toward consolidation in the trial site space—despite the fact that there are probably 30,000 or so trial site locations in the United States alone. A range of factors and forces drive consolidation, concentration and sophistication at the trial site level from growing complexity of drugs and underlying protocols to of course adhering to a plethora of regulations and guidelines to escalating costs and the need for serious technology investment. Accessing patients is considered to be a primary problem and many trial sites struggle to find and retain study participants. Other issues include talent sourcing and retention and even administrative and financial considerations such as contracts and payment terms which believe it or not continue to represent a problem for some sites. TrialSite continues to learn of cases where a research site has unfavorable payment terms. In most cases, these are not heavily capitalized organizations. On the contractual front, its not a secret that industry often prefers independent trial site organizations as the contracting process all things being equal goes faster than say the large academic medical center.
All of these dynamics help drive the trend toward consolidation, suggesting that sites become exposed to growing competitive pressures. Successful trial sites will increasingly look more sophisticated with investment in systems, tools, and processes. Of course, this presupposes access to capital, managerial sophistication, and industry know-how not ubiquitous at the trial site level.
Advarra is a leading vendor providing services and products to help trial sites and investigators—ranging from the independent organization all the way up to the largest academic medical centers—CROs and sponsors advance the way clinical research is conducted focusing importantly, on delivering value at the intersection of safety, technology and collaboration. The firm offers trusted IRB and IBC review solutions (their roots), a range of technology products including a number of site level tools, as well as managed consulting with expertise in research and the trial site organization. TrialSite can attest that its network includes impressive professionals employed by both Advarra and WCG. These organizations are investing heavily in advancing services and products—competition is healthy for the market.
As TrialSite has chronicled, Advarra has an arch-competitive called WCG, which has similar roots in the IRB space. Both are backed by private equity and both have been in a tit for tat battle, buying services and product companies targeting the research space.
Call to Action: As the research world becomes ever more sophisticated, competitive and complex, companies such as Advarra and WCG or smaller competitors with tailored offerings become increasingly important part of the ecosystem. TrialSite is an objective, unbiased digital media, information exchange and engagement platform dedicated to clinical trials accessibility and transparency. The advancement of biomedical research for the benefit of society as the primary goal. Trial sites must understand strategically where research is headed so they can be ready to accommodate and support for the betterment of the research. Feel free to send us questions on any of these topics.