Clinical trial drift can cause high PI turnover, low patient recruitment
Clinical trial drift can cause high PI turnover, low patient recruitment
Education assessment and interventions are the solutions
The clinical trial industry continues to experience problems with investigator and patient recruitment, and experts say the cause is trial drift, defined as the gradual reduction in study knowledge as a clinical trial ages.
The Tufts Center for the Study of Drug Development in Boston released a report in May showing that the number of principal investigators conducting industry-sponsored studies in the United States declined 11.4% between 2001 and 2003, while the same period had a 10.6% decline in clinical trials.1
This study highlights the ongoing trend of researchers abandoning clinical trial work due to frustration that is caused by trial drift, said Al Oviedo Pacino II, president of Hillicon Training and Assessment Campuses in Cedar Park, TX. Pacino spoke about trial drift at the 2005 Association of Clinical Research Professionals (ACRP) North American Annual Conference held April 2-6 in Orlando.
"More than half of investigators choose never to conduct another clinical trial," he noted. "Basically, the main problem in medical research is the lack of communication and assessments between sponsors, clinical research organizations [CROs], investigative sites, and vendors doing a clinical trial."
Trial drift typically occurs when clinical trial investigators and staff’s interest in a clinical trial deteriorates over time and when the average knowledge base of all personnel involved in the clinical trial or study decreases as the trial extends its timeline, Pacino explained.
"What it simply means is the longer the trial is, the more the trial drifts, depending on the therapeutic area," he said.
Trial drift is a huge problem that contributes to the research industry’s No. 1 problem and challenge of patient recruitment and enrollment, said Ruth Ann Nylen, PhD, lead consultant at the RAN Institute Inc. in Land O’Lakes, FL. Nylen also spoke about trial drift at the recent ACRP conference. "I’ve been in clinical research for 24 years, and I’ve rarely ever seen a clinical trial enroll all of the subjects at each of the centers for a multicenter trial," she added. "It’s become a far greater challenge for the pharmaceutical industry to enroll the number of subjects required within the time frame."
The cause of trial drift is inadequate investigator and clinical trial staff training about the protocol and good clinical practices, Pacino and Nylen said.
Recently, there has been a trend for regulatory agencies to require additional documentation and proof that all personnel involved in clinical trial research are informed, trained, and assessed properly, Pacino noted.
However, it’s been left up to the clinical trial industry to decide how to do this, and so far, there are few who have solved the problem, which can cost the industry millions in money wasted on inefficient subject recruitment or on flawed studies, he said.
Typically, investigators will attend an investigative meeting that uses PowerPoint presentations and videos to explain the protocol but provides no tests to assess whether the attendees fully understand the exclusion/inclusion criteria and other features, Pacino explained.
The sponsors or CROs don’t benchmark the investigators’ knowledge because they’re not assessing it, so investigators often walk away with an incomplete understanding of trials, he added.
"We don’t know if any individual understood the specific areas of the clinical trial, safety regulations, and other topics," Pacino said. "There are no metrics or benchmarks collected."
Most of the time, investigators do not fully understand specifics of what’s presented. That leads to frustration because their inadequate understanding of a clinical trial’s inclusion/exclusion criteria often leads to problems in recruiting the right subjects and interest drifts, Pacino added.
In her more than two decades of working in the clinical trial industry, Nylen said she has never seen a multicenter protocol in which every subject enrolled was 100% compliant with the protocol and regulations. "There are some situations with protocol violations that are not in the control of the sponsor or investigator, such as the patient doesn’t take his medication on schedule. That’s a violation that the patient is responsible for."
However, that violation might be avoided if the subject is properly trained by a clinical trial team and investigator who also are properly trained, Nylen noted.
When subjects miss visits, those also are violations that sometimes could be avoided through proper training and education, she said.
Better education and training is one part of the solution, but the hardest part will be to change the traditional mindset among sponsors, CROs, and clinical trial sites and convince all parties to become more invested in improved clinical trial quality from the moment a protocol is presented, Nylen and Pacino said.
"Historically, what has happened at the beginning of a multicenter trial is there’s a review of the protocol, the study-specific issues, and invariably there’s a good clinical practice component," Nylen explained. "For most investigators, when the GCP [good clinical practice] training and review comes, that’s the time when they’re in the hallway on their cell phone, and they miss it."
Nylen has taught these GCP portions of investigator meetings, and said she’s convinced there is a better way to educate investigators on good clinical practice.
Reference
1. Number of Principal Investigators in the U.S. is Declining, According to Tufts CSDD [Press release]. Boston: Tufts Center for the Study of Drug Development; May 2005. Web site: http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=54.
The clinical trial industry continues to experience problems with investigator and patient recruitment, and experts say the cause is trial drift, defined as the gradual reduction in study knowledge as a clinical trial ages.Subscribe Now for Access
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