Call to Transcend the “One and Done” & Associated Challenges with PIs & Associated Trial Site Organizations

Call to Transcend the “One and Done” & Associated Challenges with PIs & Associated Trial Site Organizations

Pharmaceutical sponsors need to do a better job of cultivating more long-term, holistic partnerships with principal investigators (PIs) and their trial site organizations. After all, with the well-known industry problem of “one and done,” the established pool of clinical investigators must perform, at times, heroic undertakings serving sponsors needs while running what are in many cases small businesses. COVID-19 only fuels a growing trend of economic pressure: a sort of squeeze on sites and their PIs leading to more consolidation and centralization of the trial site organizational landscape, not to mention the acceleration of private equity-driven M&A, which can lead to new clinical research market imbalances. Small, focused, boutique trial site organizations are also important and contribute to a dynamic ecosystem: one that emphasizes patient-centric community connection while maintaining flexibility and malleability along with personalized service that sponsors often favor.  

Michael Causey with ACRP updates the market on Christina Brennan’s, MD, MBA, CCRC, point of view in the matter of challenges to the research models forcing too much PI turnover and, of course, the “one and done” phenomena.

Dr. Brennan, vice president of clinical research at Northwell health, reminds stakeholders to consider collaborating on ways to not only work more seamlessly with existing PIs and sites, but also extend and diversify, embracing new PIs.  With only about 3% of the existing physicians in the United States conducting ongoing research, there is clearly a shortage of investigators yet at times some of the existing firms struggle with business development and client relationship management. Moreover, over the years, many PIs and associated sites report that the costs of conducting research outweigh the economic benefits. It doesn’t have to be this way. Many of these small firms must either team with networks or sell to private equity-backed consolidators as the emergence of a new kind of trial site organization will raise the competitive bar on the one hand, but possibly lead to even less choice for sponsors on the other hand. 

But with progressively worse turnover among principal investigators, Dr. Brennan is absolutely correct to call for a sort of industry intervention. Declaring that the sponsors must improve the “care and feeding” of new PIs, TrialSite could make the case that the same could be said for many existing sites. But for new PIs put in ‘sink or swim’ scenarios as they take on complicated research endeavors, perhaps new programs can create tiers so that the newly experienced can work as sub-PIs until they’re bought up to speed and sufficiently prepared.

But other problems have persisted, such as industry payment terms and onerous contracts, compliance costs, lack of experienced coordinators and what, at times, can be the sharp dealing by pharma sponsors. 

Improvement Pathways

One emerging PI and trial site organizational improvement paradigm involves site accreditation to prepare and train site organizations to perform at higher levels of productivity and quality while ensuring ever-growing commitments to patient safety. That’s the driver behind the Site Accreditation and Standards Institute (SASI) and the new, non-profit organization’s unwavering commitment to deliver to sites (and their PIs) a compelling accreditation program.

Of course, organizations such as Association for Clinical Research Professionals (ACRP) serve as a backbone foundation for certifications and myriad contribution to ongoing competency and training in the quest for improving monitor, coordinator, and investigator competencies. Meanwhile, the Society for Clinical Research Sites (SCRS) represents enormous potential as a focused site-based association representing collective engagement with industry and regulators to open up dialogues for innovative and creative new ways to raise industry standards, identify new PIs, and improve outcomes for all involved.

Additionally, what TrialSite refers to as the “super” IRB consolidation firms, such as WIRB-Copernicus Group and Advarra, these firms continue to develop and expand interesting and important offerings, driven either by internal investment or acquisition. These firms have accumulated tremendous capacity, capability and assets to help facilitate sponsor and site engagement while offering improvement programs for PIs.

TrialSite has showcased some other interesting efforts in China where industry is partnering and collaborating with trial site organizations and principal investigators to raise the bar for site performance, quality and patient safety. For example, TrialSite reported CRO PAREXEL and American pharmaceutical giant Eli Lilly initiated an exciting program to bring high-value training opportunities to China’s clinical trial sites and investigators.

With all of these organizations committed to trial site organizational and individual professional improvement, the outlook is bright for new breakthroughs targeting PI and site improvement.

Dr. Brennan brings a force of knowledge, presence and intelligence to the clinical trials industry—her call for tailored, customized professional learning, yet at scale, is important for all to hear.

Call to Action: Follow the link to read the article from ACRP