“There’s a lot more to becoming a principal investigator (PI) than meets the eye,” says Elizabeth Weeks-Rowe, LVN, CCRA. Too often, prospective PIs think it’s a matter of taking a few courses before embarking on the new career journey. Wrong, says Weeks-Rowe.
“There’s so much more they need to understand,” she says. For example, new PIs need to be familiar with expectations from the U.S. Food and Drug Administration (FDA), safety reporting issues, and how to put together and manage staff who are—or who can quickly become—experienced members of an efficient and productive clinical trials team.
The PI revolving door is a serious and chronic challenge for the clinical trial industry. A 2014 study by the Tufts Center for the Study of Drug Development counted some 40,000 PIs, with half being new to the job. In addition, although the highest turnover rates are observed among the least active investigators, turnover rates have been getting progressively worse among more active investigators.
However, the good news, according to Weeks-Rowe, is that resources and tools are plentiful for fledgling PIs. The FDA has produced a “plethora” of good information via guidance’s and other communications, she notes. “I also advise people to look at FDA’s Warning Letters to PIs” to learn how to be a better practitioner and avoid the mistakes of others, she says. “There’s so much good content and training out there,” she adds.
“Familiarize yourself with key portions of the Code of Federal Regulations: 21 CFR 50 (informed consent), 56 (institutional review boards), 11 (electronic records), 54 (financial disclosure), 312 (Investigational New Drugs), and 314 (applications for FDA approval to market a new drug),” Weeks-Rowe says.
She also encourages new PIs to focus the International Council for Harmonization E6(R2) Guideline for Good Clinical Practice, which has been adopted by FDA and other agencies around the world to facilitate the mutual acceptance of clinical data by regulatory authorities.
PIs should also be aware of other FDA guidances/information sheets, including:
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- A Guide to Informed Consent
- Exception from Informed Consent Requirements for Emergency Research
- Recruiting Study Subjects
- Using a Centralized IRB Review Process in Multicenter Clinical Trials
- Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
- Use of Electronic Informed Consent: Questions and Answers
Weeks-Rowe also encourages new PIs to explore being a sub-investigator first and/or to find an established PI to act as a mentor. Another tip: “You’ve got to get help navigating study budgets and other contracts,” she says.
Author: Michael Causey