Do a clinical study right, and leave them wanting more

November 1, 2007

As discussed in recent articles, conducting clinical research provides an opportunity to offer additional treatment options to patients and to add income to your bottom line.

Most clinical studies will gross about $50,000. You can expect a profit of 50% after your initial costs are covered. An individual clinician will usually need to conduct three to four studies at any one time to be profitable in clinical research.

First, make yourself available to the visitors and give them a tour of your facility. Show them where the patients will be seen, the reception area, the space where the drugs will be stored in a locked cabinet, the equipment that will be used for the study, and a secure, locked cabinet where files will be kept. You will also need to have a dedicated computer and access to the Internet with a high-speed connection. Serious investigators will have a dedicated computer for each clinical study they are running. Also, show the visitor where the monitors will work when they come to the office to review the case report forms.

You will be in a good position to be accepted if you can demonstrate a database of patients already in your practice who might be eligible for study enrollment. The more patients that you can demonstrate that you can enroll, the more attractive you and your practice will be to the sponsor.

Preparing a budget

You can expect that reimbursement will be at a higher level (usually 15% to 30%) than the usual fee for normal patients within the practice. Begin the budget process by asking the sponsoring company what it expects to pay on a per-patient basis. Expect an honest answer, as sponsors understand that clinical research requires more time and effort than your "usual" patients do.

The best way to check on the offer from the pharmaceutical company is to conduct your own budget analysis. This re-quires you to look at every interaction with the patient, from study visits, laboratory tests, procedures performed in the office, such as flow rates and urodynamic studies, to the coordinator's time to complete the data forms, and other associated paperwork that is required for any study. With this analysis in hand, you can estimate the fees that would be expected and compare those fees to what is offered by the sponsor.

Finding a coordinator

If there is one aspect that is critical to the success of your clinical study program, it has to be the study coordinator. This person is the key to the success of any clinical study. He or she can make the process go very smoothly and efficiently and make the study profitable, or can make the study a nightmare and make you wish you had never gotten involved in research.