Solving the problem of clinical trial drift
Solving the problem of clinical trial drift
Planning, education, monitoring are key
Finding solutions to trial drift begins at the top with the sponsor, but also requires clinical trial staff to become more committed to good clinical practices and knowledge testing, experts say.
"No. 1, a sponsor needs to establish a strategic plan for every trial, on how they are going to communicate and train and maintain the knowledge level with every site before they ever start the trial," said Ruth Ann Nylen, PHD, lead consultant at the RAN Institute Inc. in Land O’Lakes, FL.
Nylen spoke about finding solutions to trial drift at the 2005 Association of Clinical Research Professionals (ACRP) North American Annual Conference held April 2-6 in Orlando. The written plan should outline when a sponsor or clinical research organization (CRO) will communicate with sites and how they will communicate, whether by newsletter, Internet training, etc., she said.
The next step is to provide training and education that can be measured to make certain investigators and clinical trial staff fully understand good clinical practices (GCP) and a particular protocol’s details, added Al Oviedo Pacino II, president of Hillicon Training and Assessment Campuses in Cedar Park, TX. Pacino also spoke about solutions for trial drift at the recent ACRP conference.
Sponsors and CROs could hold educational sessions via the Internet and use Internet-based assessment tools to make certain investigators and clinical trial staff are meeting expectations for knowledge about research and protocols, he continued.
"If you want to do this in real time, then you could do it as a web-based program, setting up a trial campus on a virtual university and have sites involved in the clinical trial around the world do training and assessments at each participant’s own convenience," Pacino said. "Then the system collects that information based on each specific module and measures those answers, and that gives the tools for the administration and managerial team to assess individuals who are involved in the clinical trial," he explained.
When test results show certain individuals performed poorly, then sponsors or CROs can target additional education to those individuals in an effort to improve their knowledge deficits, Pacino added.
Sometimes, an intervention could be as simple as a telephone call to clarify information; and sometimes, it might require a second test to ensure the individual has learned the material after the intervention, he said.
For clinical trials lasting 12 months or longer, which most of them are, there should be documented baseline training with a performance matrix that enables a sponsor or CRO to identify anyone who needs remedial training or whether there are any systemic weaknesses in the training program, Nylen said. "One huge solution is documenting what investigators know," she explained. "Train them up front and take the GCP out of the investigator meeting."
Instead, GCP should be taught as a 45-minute to one-hour training session on-line prior to the investigator meeting, and participants should be tested after they complete the session, Nylen added.
"Then when the investigator meeting happens, the sponsor can have face-to-face time with investigators to address any problems or areas of concern because they have documentation to show where the investigator and staff were strong or weak," she said.
"We’re doing that with some sponsors for protocol specific issues, so we can help the sponsor get the best quality knowledge in the hands of investigators, so they can conduct the trial accurately, efficiently, and properly," Nylen explained.
Another way to improve deficits is by sending research associates or coaches for additional training to sites that are having difficulty, Pacino said. "You can continuously do benchmarking and assessments in a clinical trial to better manage it, so if the trial starts drifting, you can figure out why."
An inadequately trained investigator might do a poor job planning, and this could have negative impact on a clinical trial.
For example, a trial protocol requires a subject to have a return visit 14 days + two from the first visit. The clinical trial staff schedule the first visit two weeks before a holiday, which means that when the subject comes in for the visit, the second visit automatically is pushed back by four or five days during the scheduling process, Nylen pointed out.
Well-trained investigators and clinical trial staff will have planned visits in such a way that there’s preparation for follow-up visits before the first visits are scheduled, so this problem, which would put the site in violation of the protocol, does not occur, she added.
"There are a lot of logistical problems that occur, and we can help investigators and investigative site staff better understand the logistics and help them with reminders on a regular basis, using the Internet," Nylen said.
(Editor’s note: For more information about trial drift or to report trial drift problems or solutions, visit a newly formed trial drift solutions community at www.trialdrift.org.)
Finding solutions to trial drift begins at the top with the sponsor, but also requires clinical trial staff to become more committed to good clinical practices and knowledge testing, experts say.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.