As the International Council for Harmonization’s (ICH’s) Guideline for Good Clinical Practice (GCP) E6(R2) renovation project gets under way, perhaps ICH would do well to reconsider the guideline title among its other deliberations, says Jan S. Peterson, MS, CCRA, RAC, MICR, ASQ CBA, senior regulatory affairs manager for the Emmes Corporation.
“I have often observed that clinical investigators primarily responsible for the execution of a research protocol misunderstand the term or the responsibilities involved with ‘good clinical practice’ as we use it,” notes Peterson, the 2017 vice chair for ACRP’s Regulatory Affairs Committee, in a peer-reviewed article to appear in the October issue of the Clinical Researcher journal from ACRP.
According to Peterson, perhaps the GCP term is confused with the ordinary care investigators would deliver to their patients, since of course they trained for years to provide “good”—if not superior—care, the service they provide is “clinical,” and they are in medical “practice.”
“This may not be so surprising knowing that, on an annual basis, a high proportion of clinical investigators are research-naïve,” Peterson says. “Perhaps because of their initial research experience and training—or lack thereof—in leading a clinical research protocol, many first-time investigators never return to utilize or improve upon their new skills.”
Regulatory inspections seem to support this idea, since year after year, the most common citations issued to investigators are for not following the protocol.
To help everyone recognize the important difference between their clinical skills and the research activities they undertake, “I’m hoping that the title ‘good clinical practice’ (GCP) gets updated to ‘good clinical research practice’ (GCRP), in recognition that this activity is clearly not at all like providing good patient care,” Peterson says.
Peterson’s article, “Getting on Board with ICH GCP E6(R2): Impact on Study Quality and Operations,” is open to the public online from the October 2017 Clinical Researcher on the ACRP website. Other articles and columns for the issue, brought together by guest editor Glenda Guest, CCRA, RQAP-GCP, TIACR, continue the theme of “Regulations and Compliance: The Climb is Worth It” and are mostly accessible only by ACRP members.