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Jane E. Henney, Ph.D - National Institutes of Health

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery."

Remarks by:
Jane E. Henney, Ph.D
Commissioner of Food and Drugs
U.S. Food and Drug Administration

Human Subject Protection and Financial Conflicts of Interest
Commissioner of Food and Drugs

Natcher Auditorium
NIH Campus
Bethesda, Maryland

August 15, 2000

Financial conflicts of interest on the part of sponsors and investigators, and their potential impact on human subjects, is an area that is becoming increasingly complicated at the same time that it's becoming a more visible and carefully scrutinized part of the process.

The purpose for this conference is to not only consider approaches that are being used at present to manage financial conflicts of interest at the level of the institution, the IRB, and the clinical investigator, but also to see if there are additional ideas and actions we need to consider. These deliberations will be helpful to any refinements our guidance requires to ensure existing disclosure and conflict of interest regulations are effective, patients protected, and interpretation of research data as bias-free as possible.

Clinical trials play a vital role in new product development. For it is through this mechanism that data are generated to support the safety and efficacy of products and technologies that will improve patients' well-being, ease suffering, extend lives or improve quality of life. In making many of its review decisions on new products, particularly pharmaceuticals and biologics, FDA relies on data regarding safety and effectiveness that have been generated by clinical trials. It should be obvious that the quality of decisions FDA makes relies heavily on the integrity of the data submitted.

That means that every part of the clinical trial process has to be above reproach-from trial design, to recruiting the appropriate population of subjects, to obtaining adequate informed consent of human subjects, to unbiased interpretation of the resulting data.

The protection of human subjects who participate in research is fundamental. Research study volunteers, who may or may not even benefit from participating in a clinical trial, and who accept some degree of risk in doing so, deserve the assurance that their protection is top priority. If a crisis in confidence in how clinical trials are being conducted develops, particularly if research subjects no longer feel safe or protected, then new product development will grind to a halt.

While the financial conflict of interest of clinical investigators is but one of several aspects of human subject protection, it's the sole focus of this meeting.

This isn't the first time that we, collectively, have considered the issue of financial conflicts of interest and their impact on human subject protection. It's been a subject of discussion for many years. However, when Jesse Gelsinger died last fall during a gene therapy clinical trial, questions were raised about the financial interests of investigators, and whether these interests clouded judgement or influenced decisions that were made.

The nature of the environment in which clinical trials are conducted is changing. The Bayh-Dole Act of 1980 gives grantee and contractor organizations title to inventions resulting from federal research funding. Thus, the Act encourages more cooperation between government, academia and the private sector, and provides incentives that stimulate the transfer of knowledge and technology that would lead to new product development. With academic health centers more involved in drug development, at the interface between NIH and FDA, there is a need for heightened awareness - and perhaps for more surveillance - to ensure that financial conflicts of interest are not resulting in bias or even the perception of bias, in obtaining and interpreting study data.

Relationships between industry and academia are also becoming more complex. Academic researchers now serve not only as clinical investigators, but also in the roles of sponsors of IND investigations, inventors named on patents, and product manufacturers. Industry's mechanisms for paying clinical investigators to conduct research vary widely from one organization to the next and can be quite complicated. Often they're murky at best. Patients become increasingly vulnerable as individuals assume the multiple roles of physician, investigator and sometimes sponsor, and when research institutions stand to benefit financially as well. Legitimate questions arise about an investigator's objectivity, and concern for patients, versus his or her concern about the bottom line.

Let's be realistic. Profits do drive this business. Financial incentives have long been an important, and necessary, motivating force behind medical advancements. As a result, financial conflicts of interest-whether real or perceived--are now an inherent part of the process and we must deal with them. It's never been more important to ensure that adequate controls are in place to guard against improper behavior or bias--conscious or not--caused by conflicting loyalties on the part of clinical researchers.

FDA recently issued regulations regarding financial disclosure by clinical investigators. The requirements for these regulations are relatively straightforward. Sponsors who are submitting applications to FDA for review are to certify that the investigators have no financial interests in the product or the sponsor, or, if they do, to disclose those interests.

But beyond simply adhering to these requirements, there is a larger question for us as a government regulatory body and for the academic community that desires to participate in new product development...how do we foster and maintain a culture of compliance where our commitment to human subject protection-and our respect for patients' well-being--are first and foremost?

The public's trust in new technology-and in those that develop it erodes when research institutions fail to adhere to the standards of good clinical practice, do not adequately protect human volunteers, and do not adequately inform them about the risks of participating.

While it's critical that our agencies--FDA and the NIH--earn and keep the trust of the public, so too is it vital that the scientific and clinical research communities have the same vote of confidence. Discovery will only result in products if patients are willing to participate in research studies.

Some questions I hope you will thoughtfully address: Is it enough to inform human subjects of the investigator's financial interest in the outcome of a trial or the success of a particular product? Will disclosing that information to patient volunteers affect their decisions to participate? Will it make the process any safer for them? Can financial conflicts be managed in a way that doesn't adversely affect patient safety or influence the objectivity of the research conclusions?

These are difficult questions, but the answers are critical to the success of the clinical research process.

Please share your ideas and experiences over these next two days. Tell us how you, or the institution you represent, are addressing this issue. Let's find mutually satisfactory, and effective, answers that will result in proper human subject protection and safe and efficacious medical products for American patients and consumers.

On behalf of the Food and Administration, I thank you for your interest, attendance and participation.