Attachment: NHLBI Statement on Third Party Involvement in a Clinical Trial -- used in conjunction with Institute-initiated trials
The primary factors influencing an NHLBI decision to undertake a clinical trial (or the selection of a drug in a clinical trial) are the scientific opportunity, the clinical need, and the feasibility of the study. Third party involvement may increase the feasibility or value of a study. However, scientific merit must remain the primary determinant in deciding whether to implement a study.
The control of a clinical trial must reside entirely with the Institute and the scientific participants of the trial. Although third parties may have limited participatory roles in planning a study, developing its protocol, and planning the analysis of study data, definitive decisions on such matters must remain with the Institute and the scientific participants of the trial.
Once a trial is started, data confidentiality must be maintained within the Institute and the data and safety monitoring board. Except under special circumstances and by specific prior arrangement, third parties will not have access to any scientific data prior to their availability to the scientific community and the general public.* Immediately prior to their release, results will be made available to cooperating third parties. (During the conduct of the trial, third parties may be given general information concerning operational aspects of the study, such as the rate of recruitment, but they will not receive any of the detailed data on performance that is provided to the data and safety monitoring board.)
In the event that any adverse effects are encountered which, for legal or ethical reasons, may require communication with the FDA and/or IRBs, relevant third parties will be notified.
The detailed results of a study will ultimately be made available to cooperating third parties for use in such purposes as applications to the FDA and advertising. The advertising might, for example, emphasize the scientific results of studies, and note, but not emphasize, the relationship with the NHLBI. However, neither the conduct of the trial nor the results should be represented as an endorsement by the NHLBI of the drug or product under study.
Appropriate recognition will be given to the private sector institution's contributory role in the clinical trial.
* For example, in some situations, a third party may be permitted to appoint a physician or other scientist (who may be an employee) to review and provide written comments on near final major manuscript(s) for consideration by the writing committee. This will only be permitted, however, if the third party has in place a policy and process to ensure that both the manuscripts and their findings will be treated as highly confidential by the reviewer and by any (very limited number of) necessary consultants to the reviewer. In particular, no or minimum communication of such findings should be permitted "vertically" to higher management within the organization and none at all should be permitted "laterally" outside the "scientific" management path.