FDA, NEI offer joint training for ophthalmic clinical trials

Unique 2-year fellowship combines instruction in trial development and regulatory procedures.

Issue: December 15, 2006

ByErin L. Boyle

The Food and Drug Administration and the National Eye Institute are co-sponsoring a training program in ophthalmic clinical trials scheduled to start in January.

The Medical Fellowship Program, jointly sponsored by the National Eye Institute (NEI) and the FDA’s Center for Devices and Radiological Health (CDRH), will provide instruction in how to design and conduct clinical trials and research-related regulatory reviews, according to an NEI-FDA statement.

Fellows will commit themselves full time for 2 years and will be eligible for salaries and benefits comparable to federal government ophthalmologists. They will spend equal time at the FDA and NEI and have one mentor at each institution.

Fellows will design and initiate clinical studies with approval from their mentors and submit them to the NEI’s review board. If the board approves a study, the fellow will collaborate on research with the eye institute staff, the statement said.

“The objective of the NEI-FDA/CDRH fellowships is to train a cadre of physicians in research and research-related regulatory review,” the sponsors said. “By raising awareness of the requirements of regulatory review of safety and efficacy and incorporating them into the schema of development and testing from the early stages, the NEI and the FDA/CDRH will be better equipped to achieve a common goal: bringing safe and effective ophthalmic devices from the bench to the bedside as quickly as possible.”

Unique opportunity

Malvina B. Eydelman, MD
Malvina B. Eydelman

“All ophthalmologists in the U.S. have long awaited for an opportunity to understand clinical trials from all aspects,” Malvina B. Eydelman, MD, director of the Division of Ophthalmic and ENT Devices at the FDA/CDRH, said in a telephone interview with Ocular Surgery News. “This is a unique and challenging opportunity for somebody to combine knowledge in hands-on clinical trials at the NEI together with obtaining the regulatory knowledge at the FDA.”

The program has been in the planning stages for about 5 years. Funding became available only recently, Dr. Eydelman said.

Unlike many other agencies or private industry, the NEI is able to collaborate with other National Institutes of Health agencies, particularly in the study of multisystem diseases, said

Janine A. Smith, MD, a deputy clinical director at the NEI. The NEI is also more likely than other entities to conduct studies that compare two medications, she said.

Balancing research with a practice’s needs

“A lot of my clients perform drug and device research,” OSN Practice Management Section Editor John B. Pinto told Ocular Surgery News by e-mail. “The result is always intellectually gratifying and sometimes highly economically rewarding, too.”

John B. Pinto

The potential downsides are “relatively easy to manage,” Mr. Pinto said. For example, a research contract may require open-ended support with little or no supplemental income. Thus, close scrutiny of the contract is critical, he said.

Another factor is the extensive reporting of “minutia” that is entailed.

“The manufacturer’s research coordinator will try to make this as painless as possible, but [participants should] be prepared for dotting all the i’s and crossing all the t’s,” Mr. Pinto said.

Mr. Pinto advised investigators to handle any fees derived from their research as they would any other revenue, “counting toward individual production.”

“Many partners get into arguments when one doctor receives direct funding outside of the practice for their research work, while using practice resources to perform such work,” he said.

For more information:

Malvina B. Eydelman, MD, can be reached at the Food and Drug Administration, HFZ-460, 9200 Corporate Blvd., Room 250C, Rockville, MD 20850; 240-276-4200; fax: 240-276-4234; e-mail: malvina.eydelman@fda.hhs.gov.

John B. Pinto can be reached at J. Pinto Associates, Inc., 1576 Willow St., San Diego, CA 92106; 619-223-2233; fax: 619-223-2253; e-mail: pintoinc@aol.com.

Janine A. Smith, MD, can be reached at the National Eye Institute, 10 Center Drive, Building 10, Room 10S227, MSC 1863, Bethesda, MD 20892-1863; 301-435-4568; fax: 301-496-7295; e-mail: smithj@nei.nih.gov.

Matt Hasson is an OSN Staff Writer who covers all aspects of ophthalmology, and focuses on regulatory, legislative and practice management topics.

To apply for the Medical Fellowship Program

To be eligible for the NEI-FDA/CDRH Medical Fellowship Program, a candidate must have an MD or MD/PhD degree and be a U.S. citizen. Applicants must also comply with FDA, NIH and NEI rules regarding conflicts of interest and ethics and complete the required financial disclosure forms.

One fellow will be selected each year, according to the program organizers.

To apply for the program, physicians should e-mail resumes to Deborah Falls, MPH, assistant director for program operations, Division of Ophthalmic and ENT Devices, Office of Evaluation, FDA/CDRH (deborah.falls@fda.hhs.gov). Resumes should also be e-mailed to Malvina B. Eydelman, MD (malvina.eydelman@fda.hhs.gov) and Janine A. Smith, MD (smithj@nei.nih.gov).