Investigator training often lacks practical info
Investigator training often lacks practical info
Investigator turnover means too little experience
Studies continue to show a high turnover rate of investigators, which has resulted in a pattern in which only 10% of investigators have significant experience in clinical trials. Furthermore, there was a 1,000% increase in complaints to the FDA about investigators between 1998 and 2003.1
This translates into a need for improved training for new investigators and community practice physicians, who are recruited for clinical trials.
The problem is that investigator training for new scientists and community practice physicians often lacks practical information and commitment to helping them learn good clinical practice (GCP), experts say.
"Possibly the biggest thing lacking in current investigator programs is practical information," says Alicia Pouncey, Med, managing director of Aureus Research Consultants of Metairie, LA
"[Educators] could use lessons learned from scenarios within their own institutions," Pouncey suggests. "There are enough internal situations, issues, and scenarios that provide a great resource and application of the training."
Training means the most to investigators when it hits home, Pouncey adds.
Too often physicians who decide to become investigators have little knowledge of research regulations, GCP, and the required documentation, says J. Michael Dean, MD, MBA, a professor and vice chairman of the department of pediatrics at the University of Utah School of Medicine in Salt Lake City. Dean and Pouncey spoke about investigator education at the 2006 Global Conference and Exhibition by the Association of Clinical Research Professionals, which was held April 28 - May 2, 2006, in Phoenix.
"How do you take a network of investigators with highly variable skill levels and try to get across some of the basics of the regulatory aspects of clinical investigation," Dean says. "At a university, the task is very straightforward: you tell them to get IRB approval, and they have to take such-and-such training model." But this approach will only give them human subjects protection and research ethics training, he says.
The details essential to GCP in research should be provided as well, he adds.
Dean is involved with two networks of physicians, and they receive four hours of a generic discussion about different topics related to GCP, Dean says.
"We've exposed them to two hours of education on informed consent, which is a little bit more detail than they might get from their web-based training," Dean says.
Even this approach has drawbacks, such as it's difficult to reach everyone who will be involved in the research.
"The problem is you have investigators in the network who go to steering committee meetings and may have others to recruit for a study," Dean explains. "So getting the training across to that wider audience is almost impossible."
For instance, one physician investigator in a network will come to training sessions and then return home to share his information with five to 20 colleagues, Dean says.
"All of these people are going to be recruiting patients, but most networks don't have the money to bring 250 physicians together for a training session," Dean explains "It's the same thing for research coordinators and assistants."
Even convincing investigators that they need training is difficult, he notes.
"The first thing is to convince physicians in a network that there's a knowledge gap there," Dean says. "Once you've convinced them, then you have to put in an adequate budget in studies to handle training sessions."
NIH emphasizes the importance of investigator training in its NIH Roadmap for Medical Research, which includes several goals and strategies for improving education.
For example, the NIH has an interdisciplinary research training initiative with the goal of providing interdisciplinary training to investigators at all levels of their careers. Training programs include institutional training grants, curriculum development awards, and short training programs, according to the NIH Roadmap.
Also, the NIH Roadmap includes a focus on clinical research workforce training, which will address career development of clinical researchers at multiple points. Its stated goal is to attract individuals to clinical research and to enhance the careers of those already are engaged in research.
At the NIH Roadmap's inception in 2004, NIH officials said the future of research will be increasing numbers of clinical trials conducted in communities and away from large urban medical centers, so investigator training is a critical issue.
Buy-in, training key to making things work
In order for community physicians to participate more in research, they'll need more information about clinical trials, and the training needs to be simple and applicable to their particular setting, Pouncey says.
"The community physicians are very busy being community-based physicians, and their first priority is not clinical trials," Pouncey says. "So we need to increase our efforts with community-based physicians, going back to the practical application of GCP training."
For instance, training for community physicians should take clinical trial work and translate it to their everyday practice, Pouncey says.
"What are the responsibilities of the investigators, and how can they contribute?" Pouncey says. "We need to provide them with support structure staff."
For example, community physicians often cannot afford to hire trained research staff to support their work in a clinical trial, so that support staff should be made available by the sponsor, Pouncey says.
"That's a practice that has fallen out of favor, and certain sponsors do it and others don't," Pouncey says. "The idea is to provide an investigator with salary or part of a salary to pay for staff."
Staffing with community-based physicians is something that needs to be addressed because the training issue is about more than providing knowledge, Pouncey adds.
Investigator and clinical trials staff education can be ongoing through monitoring and feedback, Pouncey says.
For instance, an institution could use a "report card" to provide feedback to investigators about enrollment success, deviations to the protocol, and site performance, Pouncey says.
"I'm a huge fan of that approach," Pouncey says. "It's a great mechanism, and it generates an atmosphere of cordial competition."
Likewise, positive reinforcement would be more useful than the current system of providing negative checks and balances through regulatory warning letters, Pouncey says.
"We've set up an almost penal environment where we publish the Food and Drug Administration's warning letters and talk about noncompliant investigators," Pouncey says. "I'd much rather have us reward investigators who do it correctly, even giving them additional budget fees."
Current clinical trial budget practices rarely include rewards for quality, Pouncey notes.
"At the end of the day, sponsors benefit because they have quality data," she adds. "But there's no system in place to reward those investigators who are doing things correctly."
Instead of spending millions on audits and monitoring visits, the clinical trial industry should spend more time on educating and rewarding those who do a good job on studies, Pouncey says.
Pouncey is asked occasionally by investigators whether their undergoing certification would make a difference in their clinical trial contracts and reimbursement.
"I like to think it would, but I'm not aware that it would make a difference," Pouncey says.
It's possible the current trend of shortages of investigators and trial volunteers could lead to major changes in how clinical trials are monitored and funded, but, so far, there are few improvements, Pouncey notes.
The trend has increased competition for investigators, but when sponsors have to get a project completed, they sometimes are forced to look for investigators who are not at the top pier, and this is why more education is necessary, Pouncey adds.
Broad-ranged and generic curriculum is not ideal, so the goal now is to provide training about specific aspects of research, related to a specific trial, Dean adds.
Training should occur before the investigator and research coordinators begin the study, and then the research coordinators should be given additional training a month into the trial, Dean suggests.
"With this approach, you would have fewer inquiries and mistakes and phone calls," Dean says. "But most funding agencies don't put that kind of money up front into training, and the training materials have to be very specific so you won't waste people's time."
There's a learning curve in doing research, and the institution that fails to pay for training up front will end up paying for mistakes at the back end, Dean says.
"That lesson applies to drug companies and various sponsors of studies," Dean says. "They cut back on up-front training and think they'll get by, but then they end up paying for it later through errors and problems."
Practical education is training at a higher level, Pouncey says. Training provides the basic education and gives investigators a knowledge of some skills, but practical education shows them how to use what they've learned in the real life setting of a clinical trial, she explains.
For example, teaching an investigator or clinical trials professional how to conduct informed consent can only be done adequately with hands-on education or role-playing, she says.
"You have the physician take the staff and say, 'This is the trial we're conducting, so you consent me to the study,'" Pouncey suggests. "Or do it vice-versa, so both parties understand what their informed consent responsibilities are."
Physicians don't start out as investigators with the intention of being noncompliant, Pouncey says. "But a large number of these individuals aren't aware of the information and responsibilities they've signed up for," she says.
Reference
- Pouncey A. Training Phase IV physicians. GCP Journal. (www.gcpj.com); April 2006:16-18.
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