Global Standardization of GCP Training


Applied Clinical Trials

Amsterdam was the stage for the first-ever edition of a two-day Science2Business conference entitled "Academia-Industry Collaboration for New and Better Medicines," organized by Science Alliance, on behalf of the International Federation of Associations of Pharmaceutical Physicians, on April 18 and 19. With the bright sun reflecting on the river IJ just outside the venue, setting record-breaking spring temperatures, the attendees were updated on recent developments in the fields of safety reporting in investigator-initiated trials, pitfalls in partnering between academia and industry, and collaboration models for successful research and its publication.

The closing session was a roundtable meeting that discussed the challenges encountered, or to be encountered, when striving for the standardization of GCP education. This session was attended by 24 professionals from diverse research affiliations. Research physicians from general, teaching hospitals, and from university hospitals; research coordinators and QA staff from the larger university hospitals; decision makers from mid-size pharmaceutical companies; and policy makers associated to universities, large hospitals, and from research-funding governmental organizations, were present.

Interesting and thought-provoking questions came to the table straight after introductions.

Should investigators be trained repeatedly on GCP, by one sponsor for one of their trials, and the next month by the sponsor of yet another of their trials? Potentially, this could lead to decreased interest in the GCP topic as a whole. One of the delegates suggested any GCP training should first of all create awareness on the day-to-day conflict of interest; a physician informing a potential trial subject to participate in a trial that brings about certain risks, yet on the other hand the physician has sworn to Hippocrates’ Oath, which is to do no harm.

Another wish was that training should aim at changing a research staff’s mind-set. What is needed from GCP or what is helpful to know to enable staff to continue delivering high-level patient care, combined with research activities. The incentives of GCP education were clear to all, namely benefits for both science and patients. But then, should there be a single training standard for all persons on a research team, regardless of individual job title or responsibilities?

The majority of attendees then agreed to following the basic scope of "GCP training for research staff"’; GCP ideally should be educated continuously, in sessions aimed at all research staff individuals alike, with built-in and sufficient peer-to-peer discussion on common sense topics and practical examples from the "real life/the floor." Repetition of the same education session is not warranted. Instead, two levels of training would be appropriate (which is the situation in Singapore), one basic course that can be taught in two days and is compulsory by Law, followed by either refresher courses or advancement courses the following year.
How should this education and training be built and what concepts should it cover? Here, at least one interesting concept needs mentioning. Rather than knowledge-based, training should be outcomes- and competency-based, with competency being the product of ones’ knowledge, skills, attitude, and behavior. This idea was further clarified by another attendee as the "driver license situation," which is that a person has obtained a license to drive a car in virtually any country, and may proceed to do so. The question is if this person really drives safely.

Well-placed as the closing remark of this session was that of a network collaborative group, known as PharmaTrain. The soon-to-be-rolled-out business plan is to have course providers reach common ground on the learning objectives first, next building a curriculum or syllabus, and setting out educational plans in the field of clinical research professionals, including GCP. The training or curriculum would preferably be accredited by an already established accrediting organization, preferably tapping into Continued Professional Development plans already fostered by some professional organizations.

Good and indeed thought provoking discussion demonstrated that standardization of GCP training and education would be appreciated very much, by virtually all working in clinical research operations and management. To this end, steps ahead are defining the actual curricula and thus the set of competencies, and looking at options to have multinational training programs accredited.

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