Taking part in any good “bootcamp” experience worth the name—be it to better oneself physically, mentally, or in any other way—should significantly challenge an attendee without crushing his or her spirit for doing whatever the task(s) are that serve as the focus of the bootcamp exercises. Further, it might be best not to be a novice at the material one will be sweating over during the possibly intense experience.
So what challenges are thrown at participants of a bootcamp that centers on clinical research?
Judging by the evidence of the “Let’s Get Clinical! A Research Bootcamp” full-day workshop held at the ACRP 2017 Meeting & Expo on April 28 in Seattle, Wash., the challenges are many and varied. Workshop leaders David Morin, MD, FACP, CPI, director of clinical research for the Holston Medical Group of Sites, and Jill Chapman, BHSc, CCRA, senior manager for training and development with the Association of Clinical Research Professionals (ACRP), put attendees through the paces of scenarios based on situations that could arise at study sites regarding the proper conduct of informed consent, reporting and reacting to adverse events, handling essential documents, and developing “soft skills” in research settings.
According to Morin and Chapman, the engaged group of bootcamp participants were not brand new to clinical research, but had anywhere from nearly a year to several years of experience in the field, so the concepts being taught were not necessarily unknown to them, but they did not have deep experience in most areas.
Among many other situations, the attendees were asked to discuss and debate:
- When can an investigator take a patient off a study, even if he/she wants to continue participating?
- What if a patient wants off the study drug, but still wants to remain in the study? Or if a patient withdraws consent for being in the study, will he/she allow the already-collected data to be used?
- Does a principal investigator have to accept a volunteer patient into a study when he/she matches the inclusion criteria?
- What if a patient declines to participate in an optional sub-study that serves as an offshoot of the main study?
- How does one handle consenting a pediatric patient into a study if his/her parents are divorced with joint custody?
- What if a 10-year-old doesn’t wish to participate in a study, but his/her parents are insistent upon it?
It’s not that every study site will encounter every one of these scenarios, Morin and Chapman say—it’s simply a good mental exercise to pose them and to see how attendees with different levels of experience and backgrounds would handle the challenges. This way, everyone learns from each other in a safe setting.
So researchers on a quest for a bootcamp experience that won’t leave them physically exhausted at the end of the day should consider doing it the ACRP way.
Author: Gary Cramer