What to Know Before Starting Clinical Research

What to Know Before Starting Clinical Research

Conducting clinical research trials as part of regular dermatology practice connects dermatologists with the foundation of medicine. But while it may hearken you back to what you loved about your science background, it is also not as easy to pull off as you may think. In fact, there are significant regulatory considerations to keep in mind before accepting your first clinical trial project. Take it from me – one way or another I’ve been conducting research as part of my practice for nearly twenty years. Learning the pitfalls to avoid will help create another rewarding facet as a dermatology scientist.

Pitfall #1: Learn the market for research before moving forward.

You have to know what you’re doing before you start marketing yourself as a clinical researcher. There’s no “fake it until you make it” here. If you aren’t truly ready, you put your practice and career at risk.

Readiness includes taking a few different steps. You’ll first need to establish your clinical research team as a separate incorporated business with its own liability insurance and procedures. It is not as easy as waving a magic wand and turning medical assistants into research coordinators or managers into regulatory associates. You’ll also need to comply with federal and state regulations including, not just FDA regulations and HIPAA, but Good Clinical Practice (GCP) and many other trainings as part of demonstrating proficiency and ability to perform research. You’ll also need to hire a team to handle regulatory requirements, data entry, coordination and recruiting. Finally, you’ll need to determine in advance how you plan to market your trial site to sponsors, CROs (contractual research organizations) aka the “middleman,” and a new type of patient aka the “research subject,” who in many ways is more of a customer than patient. 

While you may be antsy to start conducting research, slow down your process and make sure you have taken every measure possible to set your clinical research organization up for success. Even more important is to do the homework, read the books and courses, and ask your colleagues how to get started. Trust me – it’s worth the wait. There are too many problems that could go wrong if you rush the process or skip a step.

Pitfall #2: Your practice and clinical trials units are comingled.

As part of operating as a separate business, you’ll need to keep your clinic and research organizations distinct in how you manage your office, starting with separate financial entities and business identities. Keep clinic charts separate and, if possible, keep your patients and research subjects in different waiting rooms. The term “firewall” will become a mantra for blending the practices. Make sure everyone – staff, clinic patients and research subjects, and especially sponsors and CROs – know the difference between your medical practice and your research business.

Pitfall #3: You fail to see clinical research as a business.

While clinical research is science at its very nature, you can’t effectively conduct research without consideration of it as a business. You’ll need a process for evaluating contracts and an accounting and financial assist for reviewing study budgets, which is often the polar opposite thinking of conventional billing of insurances. You’ll need to determine the feasibility of studies that come your way and the risks they pose. For example, as interesting it was to study autoimmune diseases in training, it is difficult to find patients with SLE and dermatomyositis who are willing to enter into a research trial and risk placebo while giving up their steady treatments to be in a trial. You’ll also need to create marketing plans just like any other business or risk not having enough patients for your study, usually with the approval of the IRB (Institutional Review Board).

Pitfall #4: You fail to prepare for inspections and audits.

Sponsors, CLIA, and the FDA inspect research centers and can cite you for deficiencies or violations. Make sure staff members are trained to oversee quality of the lab, review and audit the research documents, and protect all aspects of your research business from patient safety to financial risk.

Pitfall #5: You don’t report compensation.

You absolutely must report any compensation of more than $10. This includes lunches in the office whether you attend or not. It sometimes seems that I have to report everything in my life, but it’s not that far from the truth.

Pitfall #7: You have a conflict of interest.

The FDA has high demands for reporting any conflict of interest. Make sure your promotional activities are not in conflict with FDA requirements. Due diligence is of utmost importance in protecting your reputation.

I hope these pitfalls haven’t scared you from pursuing clinical research. It’s such a rewarding experience if you take the time to make sure you’re following the right steps for launching a clinical research organization. One final suggestion: Ask a mentor for advice! Find a dermatology researcher with a career you’d like to model and ask them for their top tips. 

Author

  • NEAL BHATIA, MD DIRECTOR OF CLINICAL DERMATOLOGY THERAPEUTICS CLINICAL RESEARCH Dr. Neal Bhatia is a board-certified dermatologist in San Diego, California. He serves as Director of Clinical Dermatology at Therapeutics Clinical Research. He is as chief medical editor for Practical Dermatology. He has a background in immunology and has interests in mechanisms of therapy, skin cancer, and medical dermatology.

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