Can Your Practice Handle Clinical Research?

If you’ve never considered clinical research appropriate for your portfolio of service offerings, or have, but decided it’s too daunting of a task, Alvin Wells lays out the steps necessary to integrate this personally and financially rewarding aspect of medicine into your practice.

Understanding Costs, Obvious and HiddenObvious costs comprise issues such as:

- Infrastructure - Do you have appropriate staff levels?

- Space - Is your facility of adequate size to perform procedures and store documents

- Equipment - Do you have access to, or can you afford to purchase a freezer, centrifuge, x-ray for radiographic studies, MRI, CT, ultrasound, etc. Hurricane Katrina exposed unforeseen liabilities for many clinical research facilities, so those located in areas prone to natural disaster should take that into account as well.

“The Costs of Conducting Clinical Research” pegged the average cost per enrolled subject, excluding overhead, at $6,000, including $1,900 devoted to nonclinical costs. Furthermore, the authors found that 30 percent of a researcher’s time was spent on non-clinical activities including paperwork, negotiating contracts, and institutional review. Other hidden costs to consider are time spent before an independent review board, source document development, study preparation, site initiation, recruitment & retention of subjects, and study delays.

If you find that you are financially, physically, and mentally ready to take on clinical research, your next step is to Identify a study. Contacting drug companies and directors of clinical research to discuss their research directions, examining conference content, and scouring scientific journals are excellent ways to figure out un-targeted research areas and unmet needs in the medical community. After coming up with a few ideas, present them to universities, pharma companies, government agencies, and other entities with research dollars.

If you get a lead “assess your true ability to perform the study well,” says Wells. This includes getting the support of staff and being honest about your “ability to recruit the appropriate number of patients.” Once someone decides that you’re a candidate for their monetary support, you must prepare for a site visit. Allot an adequate amount of time for the visit, make sure you’ve brushed up on the protocol, make every one of your resources available, and, above all, make sure your facility is presentable.

You got the study!Now that you’ve won the research dollars, it’s a matter of executing the plan you laid out when applying for grant money. You must compile source documents, establish an effective recruitment plan before the start of the study, enroll quickly, perform the study accurately and with frequent quality assurance checks.

What not to doEven if you think you’re ready to handle a clinical research load, Wells cautions against improper planning and issues his 100 percent Absolute Do Nots:

1) Never overestimate your ability to perform a study well in terms of quality or your ability to recruit.

2) Do not manage competing studies. Ever.

3) The budget. Must. Be. Right.