A significant number of trial investigators are abandoning the field of clinical research, sometimes after only a single study. When the Clinical Trials Transformative Initiative (CTTI) noted this high investigator turnover, they decided to issue guidance on how to tackle the issue. Established by the FDA and Duke University, CTTI is an organization dedicated to improving the clinical trial industry—the trials themselves, the safety of participants and the obligation to stakeholders. Their focus is on clinical trials performed for regulatory submission.
Pamela Tenaerts, executive director of CTTI, said, “The issue of investigator attrition and the potential risks that this presents to the clinical trial enterprise has often been cited over the last decade, but particularly over the last few years by Tufts University and others. ... In 2014, based on many discussions and membership input, it became evident that we needed to conduct a project on site quality. Initial research and findings evolved the project to focus more specifically on improving investigator longevity as a way to improve the quality of clinical trials.”
The “one and done” phenomenon was described in a CTTI study at Duke University by Corneli et al, who noted that more than half of the investigators who responded to their survey participated in only a single trial. The burdens cited as affecting the decision to participate in further studies were workload balance issues, time constraints, data and safety reporting issues and financial concerns. A study conducted by Tufts University had similar findings, noting that half of global investigators were new to the field. Both active and less active investigator groups experienced turnover, with rates increasing in the former group.
Investigators must manage their time wisely and balance the demands of running a clinical trial with their preexisting workload. Many investigators in the Duke survey cited long work hours and a lack of time to perform other clinical or non-clinical activities as a reason for stepping away from research. They noted the amount of safety data reporting, and the methods of reporting, as additional burdens.
There may also be significant financial burdens associated with conducting a clinical trial. Liz Christianson, client engagement manager at PFS Clinical, said, “What sponsors often fail to recognize are the time-associated costs for both the site and the principal investigators (PI), in particular. Much of the time spent cannot feasibly be linked to a specific patient or visit, yet sponsors rigidly attempt to stick to this type of reimbursement format.”
She continued, “Reimbursement for the time spent should not be entirely dependent on patient visit completion; most of that time will be incurred regardless.” There are also financial burdens to investigator attrition, however, as it costs money to train investigators.
Having a high number of inexperienced investigators also has the potential to negatively affect the trials themselves. “The phenomenon [of investigator attrition] is believed to be linked to inefficiency, instability, increased costs and possibly lower quality clinical trials,” said Tenaerts.
Investigators in the Duke/CTTI survey noted that the budgeting and contracting processes for clinical trials were suboptimal. Administrative hurdles also exist. Christianson noted, “Lack of administrative backing from their institution and supportive manpower can be a huge deterrent for PIs. … Poor trial design and onerous data reporting requirements feed this ‘one-and-done’ phenomenon.”
Christianson continued, “As with any other industry, funds are needed to employ a sufficient number of staff and to keep wages competitive enough to attract top candidates. ... Without support staff, the time burden falls on the PI. This is not good for their on-trial or off-trial patient care. Without appropriate manpower, patients suffer.”
The Tufts study found that logistical concerns had an effect on recent clinical trials, with significant variation seen in study-site infrastructure and experience levels. It also noted decelerating growth in the number of PIs globally and an absolute decrease in the number of active investigators in China and India.
Many investigators participating in the Duke study noted that they would actually like to participate in more than one trial but did not know of available opportunities. Others were truly “one and done”—one participant was quoted as saying that studies involved “too much effort, without enough help, with too much bureaucracy, for no recognition.”
Christianson agreed. She said, “Protocol amendments, sponsor query responses, monitoring visits, etc., are all time suckers. At the risk of sounding too money focused, I conclude with the motto ‘time is money.’”
The new guidelines attempt to address the administrative, financial and logistical difficulties faced by investigators. The recommendations describe the development of site-based infrastructure and staff (e.g., using experienced research coordinators, providing training, using standard operating procedures, acknowledging the contributions of PIs). They also discuss improving study design, recruitment and protocols and selecting sites appropriately to reduce the changes of a failed or flawed trial influencing an investigator to quit the field. The guidelines bring attention to budgeting issues and offer suggestions for how to involve researchers in additional studies.
“The role of investigators is complex and difficult, and there is a need to create a system that supports a successful and sustainable investigator network to secure clinical trial execution,” said Tenaerts. “CTTI ... has developed new recommendations for many groups—clinical research organizations, sponsors, health systems, investigators and others—to collectively address this gap and, ultimately, help the clinical trial enterprise mitigate this ‘one and done’ investigator phenomenon.”
This article was reprinted from Volume 21, Issue 42, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »