Accreditation of PIs may be the answer

Soon certification exams may be required

Clinical research experts say the industry is beginning to recognize the need to hold clinical investigators to similar standards for practice and accreditation as physician specialists by requiring them to become certified in the practice of clinical research.

Within the past few years, research organizations have initiated or expanded clinical trial certification to include principal investigators (PIs).

The organizations that offer certification programs for PIs include the Drug Information Association of Horsham, PA; the American Academy of Pharmaceutical Physicians (AAPP) of Apex, NC; and the Association of Clinical Research Professionals (ACRP) of Alexandria, VA. Also, several other organizations offer certification for clinical research professionals or associates.

Clinical trial administrators and research managers should embrace the certification trend because it ultimately will mean more knowledgeable investigators and improved safety for clinical trials, experts say.

For example, a worst-case scenario in the clinical research field involves the all-too-common scene in which physicians get involved with clinical trials only to decide after finishing one or two trials that this is not them, says Greg Koski, PhD, MD, CPI, senior scientist for the Institute for Health Policy and an associate professor of anesthesia at Massachusetts General Hospital, Partners HealthCare System of Harvard Medical School in Boston.

"They suddenly realize this is hard work and so they do one trial and say, That’s it for me,’" Koski says. "That means people who have perhaps the least level of training experience and commitment are doing a large number of trials."

Requiring clinical investigators to become certified would be a good first step in the direction of weeding out the dabblers and improving the skills level among the remaining clinical researchers, he notes.

Certification is a positive move to enhance the conduct of clinical studies and further safeguard the protection of individuals participating in clinical studies, say Jeffrey W. Sherman, MD, FACP, chief medical officer and executive vice president of NeoPharm Inc. of Lake Forest, IL, and Irwin G. Martin, PhD, acting executive director of the Drug Information Association.

The driving concern behind certification is subject/patient safety, says Joan L. Drucker, MD, CPI, medical director of AAPP.

"We consider an adequate education ultimately is what’s best for patients and subjects in clinical trials," she says.

AAPP started its certified physician investigator program (CPI) in 2003 in response to the nation’s need for training of clinical investigators, Drucker notes.

"In the late 1990s, the Institute of Medicine was holding a number of clinical research roundtables to see what were the needs of clinical investigation in the United States, and they developed a number of recommendations, and some are similar to what you see in the National Institutes of Health research road map," she explains. "But one area that caught our attention was a sense that there is a greater need for training of clinical investigators in the future."

The AAPP certification program offers only one designation, the CPI, and it’s available only to MDs or the equivalent, Drucker says. (See chart on researcher certification programs.)

ACRP, which began certifying clinical research coordinators (CRCs) in 1992 and clinical research associates (CRAs) in 1995, first offered a certifying exam for investigators in North America in 2002, says Carol D. McCullough, RN, MBA, director of certification, credentialing & accreditation of ACRP.

"To date, ACRP has certified almost 15,000 clinical research professionals, including 245 investigators worldwide, with 206 from the U.S. and Canada," she reports.

All three PI certification programs require successful completion of an examination that demonstrates mastery of good clinical research practices, research ethics, regulatory affairs, study design, and other areas that a clinical investigator should know, says Koski, who helped write the exam for AAPP and was involved in the early stages of developing the ACRP’s examination process.

Physician investigators who are actively involved in clinical research would probably be able to pass the exam with 30 hours or fewer of study, Koski estimates.

There are several courses offered on-line and also by these various organizations to prepare people, particularly in good clinical practices and regulatory affairs, he says.

"One of the great benefits of an examination and certification process like this is it gets people to take the time to look at things they might not otherwise have looked at," Koski says. "They may come across new information they didn’t know, and just preparing for the exam helps to improve the knowledge base for those involved in the clinical trials process."

National standard on the horizon?

As momentum builds for research physician certification, there has been some discussion about creating a national certification standard, and, eventually, moving toward one certification process, Koski says.

"There have been some very early discussions among representatives from the three organizations to explore various ideas and opportunities," Koski says. "We’re moving in that direction, and my personal view is that a failure to do so would potentially undermine the acceptance of the investigator certification because people will be less likely to know what it means."

"ACRP does favor having one investigator designation that would become a standard for the clinical trials industry," McCullough says.

"Historically, ACRP had discussions with several organizations prior to anyone having an investigator certification program for just that reason," she adds. "Just recently, we have participated in a conversation with other organizations and agreed that we would begin to explore the possibility of moving toward a single investigator certification."

From the perspective of investigator training, it really should be a national standard, Drucker says. "We support the idea that there should be a common standard for everyone to be measured against. We’re having some very preliminary discussions with the other organizations we know of and some outside third parties to see what it would take."

DIA has not endorsed nor dismissed the idea of a single designation for clinical investigators, Sherman and Martin say.

However, they note that a single standard already is in place for physician specialty areas, such as internal medicine, for certification, which is done by the American Board of Medical Specialties, and for other areas, such as drug approvals by the FDA.

"Why is this area of medicine, such as this clinical investigation, the only one that doesn’t require separate training?" Drucker says. "Any other practice of medicine requires specialty training and licensing before you can see patients, and somehow there’s a feeling that if we’re experts in our specialties then we ought to be able to sit down and read the regulations and know what to do, and most of us do."

However, when national headlines highlight the deaths of patients participating in clinical trials and other problems, then it requires the research industry to take a look at the whole process and think about making it better, Drucker adds.

"We think having investigators trained specifically in requirements of how to do a trial and patient safety would ultimately lead to a safer end result," she says.

Certification programs provide a way to demonstrate compliance with standards of professional practice in the conduct of clinical trials, McCullough says.

"The certification of investigators and the whole clinical research team helps ensure that they have a well-versed knowledge of good clinical practice requirements for the conduct of high-quality clinical trials and are able to assess their application in practical situational scenarios," she adds.