So, you go to a restaurant and you order steak. What comes to the table doesn’t remotely resemble the savory course you envisioned. In fact, you can’t even tell exactly what sort of carnivore was slain for your dinner. Do you eat it? Not usually? Without a good sense of what you are getting into, you are less likely to take an action.
Let’s focus this construct on clinical trial management – put simply, all the players are not adequately informed about what’s on their plate and what is expected of them. From the sublime to the ridiculous:
When doctors are hired to be investigators for a clinical trial there is a real contract between them and the sponsor to perform. In this instance, their prescribing behavior post-approval of the drug cannot take first priority over creation of clear expectations around their job of recruiting, enrolling, and caring for patients participating in the trial.
When a lab, IWR, or recruitment vendor is subcontracted by a CRO, and a meeting needs to take place to evaluate next steps, the CRO cannot hold the agenda for the meeting until the day of the meeting, leaving the vendors powerless to plan and adjust schedules and participants. Yes, the CRO is paying the vendors but, the element of surprise is not helpful in a world where partnership between players is so critical to success.
When a clinical research coordinator is overloaded with multiple trial responsibilities, referrals often do not get processed. What is the likelihood that this person will actually ask for more help in order to do her job well, versus the likelihood that the referrals gained from advertising are deemed unworthy of processing to begin with?
“Politics and poker” prevent clear delineations of expectations and too many times objectives get crossed and what suffers is on-time enrollment. A frank and open discussion about what’s really going on is sometimes all that’s needed. Maybe what you ordered was chopped sirloin and a closer look at the menu and a discussion with the waitress is all that is needed. Bon appétit!
Joan F. Bachenheimer is co-founder of BBK Worldwide, the world leader in patient recruitment for clinical research and development. Over the last 28 years, Joan has been the vital, driving force behind the development of patient recruitment as a discipline in its own right. Leveraging a deep understanding of the clinical research industry, she develops far-sighted recruitment solutions that are yet practical and highly cost-effective to deliver success after recruitment success. Joan’s energy and acumen have never waivered, producing innovations that continue to shape the field and keep BBK at the forefront of emerging trends. Joan is the director of the BBK Management Board.