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Next Steps Toward Addressing Challenges at Study Sites – ACRP

Implementing trials at study sites is a process fraught with challenges. About 80% of clinical trials fail to achieve enrollment targets and timelines, with resulting delays costing up to $8 million per day in lost revenues for sponsors.{1}Contributing factors include avoidable protocol amendments. A Tufts Center for the Study of Drug Development study reported a 60% rise in the average number of amendments per protocol over the past seven years, with 80% of late-stage Phase III protocols averaging 3.5 substantial amendments.{2} Added to this, clinical research site numbers continue to fall, and around one-half of principal investigators (PIs) are “one and done,” meaning they don’t return to oversee a second study.{3}

“Clearly, there is scope to improve the environment for conducting trials at sites,” states Nancy Sacco, PhD, Vice President and Head of Clinical and Site Development Operations at SiteBridge Research Inc. “Promising sites are ones where a physician is enthusiastic about participating in clinical research. We put a lot of effort into these sites because with the necessary support, be it people or technology, they will perform best.”

“However, delays at the sponsor end—for example in providing an initial contract or the final protocol—can be disheartening for investigators,” notes Sacco. “We’ve seen some sponsors handle delays well and some not so well. In one example, a sponsor was ramping up sites for a new study when its development team learned that the program was not meeting its objectives. The sponsor quickly canceled all upcoming site meetings, and followed up with well-orchestrated communications to explain the decision to cancel the planned study. The physicians understood the decision and expressed willingness to work with this sponsor in future.”

“In a second example, the sponsor made a last-minute business decision to cancel a planned study, but failed to communicate this to sites,” Sacco continues. “Physicians at the sites were left wondering what was going on—and ultimately said they had no desire to work with this sponsor in future. The takeaway message is that study sponsors should keep in mind the impact of their decisions on others—especially the investigators who might be able to conduct future trials.”

“We often face the challenge of sponsors’ unwillingness to work with research-naïve PIs,” notes Nadia Aldhalimy, Director of Site Optimization/Engagement and Feasibility at SiteBridge. “Yet, these inexperienced investigators are often highly motivated to participate in clinical research, as well as having the patients and the therapeutic experience being sought. We can help resolve this challenge by supporting the new PIs. This may include preparing them for likely questions during a sponsor preselection visit to their site, and encouraging them to fully familiarize themselves with the study protocol and the results of [earlier trials on the product]. Sponsor questions may include the size of the investigator’s patient population, how they would approach recruitment and retention, how they would envisage handling any adverse events, and how familiar they are with current technologies. Overall, sponsors are looking for reassurance that the investigator is willing to embark on research and has the skill set, patients, time, and motivation to complete the journey successfully.”

“Overcoming the issue of PIs being ‘one and done’ is another major focus of our activities,” adds Micki Le, Director, Clinical Research Coordinators and Project Managers at SiteBridge. “We have developed a ‘trial-in-a-box’ toolkit designed to support research-naïve PIs [as they handle] study elements such as feasibility, contracts, budget negotiations, and staffing. We can also provide eSource technology, support study recruitment, and help with community engagement—supporting a positive experience for the PI and encouraging their future clinical research participation.”

“Tech overload remains a big issue, with sponsors having multiple platforms, each requiring specific training for study coordinators and participants,” notes Le. “This causes frustration that may lead to patient noncompliance and drop-out. I’ve seen studies [tracking] as many as 50 [electronic patient-reported outcomes], requiring high levels of competence from site staff and participants alike. Tech support takes up a great deal of site staff time, and yet often isn’t accounted for in budgets.”

Let’s Get Better at Conducting Trials at Study Sites

Join Nancy at ACRP 2024 [May 3–6; Anaheim, Calif.], as they present serious considerations for improving the environment for conducting trials at sites. View complete schedule.

“Another key element that requires attention is transparency, which is essential at all levels of the clinical research ecosystem—providing all stakeholders with a realistic picture of expectations and next steps,” says Aldhalimy. “Research is a journey, and is more likely to have positive outcomes if all parties have a clear understanding of the processes involved.”

“Looking ahead, one positive step would be for sites to be given more of a say in the choice of technology platforms for a particular study,” says Le. “Provided that site platforms are fully compliant, this flexibility from sponsors could yield efficiencies for coordinators and physicians, without negative impacts on the study. While no single stakeholder is responsible for the many challenges facing clinical research, we all need to be open to change, working together to build open dialogue and develop actionable and sustainable solutions.”

References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673977/
  2. https://www.appliedclinicaltrialsonline.com/view/shining-a-light-on-the-inefficiencies-in-amendment-implementation
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5936741/

Edited by Jill Dawson