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Everything you wanted to know about a clinical research site but were too afraid to ask

Friday, December 1, 2017

Clinical research is intense. Deadlines are tight.  Protocols are complicated.  But we all have the same goals: deliver safe and effective medications to patients who need them. Sometimes sites, monitors, CROs and sponsors collectively forget that there are human beings behind every email, but that’s what every site has to keep in mind if the principal investigator wants a successful trial.  Here’s what else you should know about working with sites.

We work really, really hard. Enrolling appropriate subjects for a complicated trial consumes the administrative time and energy of 15 routine office (non-research) patients. 

A reliable site sees every protocol. Our site routinely declines twice as many trials as we accept. The management and oversight of the trial are just as important as the contracting. After all, it is our responsibility to conduct the trial according to protocol and the CRO/Sponsor’s responsibility to assist us when it comes to being “inspection ready.”

Work with us. Sometimes it feels like sponsors and CROs are working against us. Please monitor us on schedule and keep up your end of the contract. 

PIs want you to be a mensch. That’s Yiddish for a human being. Develop protocols with open-label extensions. Offer the drug to subjects after FDA approval even if they are not insured or if insurance does not cover the medication. 

I, like many others, am a clinical researcher and a practicing physician on the frontlines with patients who have no or inadequate therapy for their ailments. Our primary goal is to help our patients, which is why it’s essential to remember the site is a crucial ally. Sites want sponsors and their studies to succeed, and working together—and keeping the mensch in mind—can get everyone there.

 

Guest Contributor Seth B. Forman, M.D., is a principal consultant at Forsight Consulting, principal investigator with Forward Clinical Trials and board-certified dermatologist and founder of Forman Dermatology & Skin Cancer Institute. He is a leading clinical researcher and consultant who provides expert analysis on trial design, data analysis, strategic placement and market analysis. Dr. Forman has consulted with pharmaceutical companies, such as AstraZeneca, AbbVie, Abbott, Celgene, Cellceutix, Cutanea, Dow, Eli Lilly, Genentech, Janssen, Medimmune, Novartis, Pfizer, Regeneron, Valeant and Ziarco.

This article was reprinted from Volume 24, Issue 12, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

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