Docket Management
Docket: 02D-0320 - Guidance: Use of Clinical Holds Following Clinical Investigator Misconduct
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Jenny Peters Date/Time 2002-11-14 09:46:33
Organization Pharmacia
Category Company

Comments for FDA General
Questions
1. General Comments Dear Sir/Madam, Pharmacia appreciates the opportunity to review the draft guidance, “Use of Clinical Holds Following Clinical Investigator Misconduct.” 1) We suggest that the wording be modified so that it is absolutely clear that inappropriate behavior by one investigator could not result in a clinical hold on a site under the authority of another. For example, at the top of page 4 is the statement, “One means of acting promptly to protect human subjects after the discovery of serious investigator misconduct is to impose a clinical hold on those studies or study sites involving the investigator.” Although the next sentence addresses our concern, one could infer that an investigator’s inappropriate conduct could result in a hold on the study, not just a hold on the particular site. Perhaps the term “study site” should be used throughout, rather than “studies or study sites”. 2) The consequences of interruption of a study might be mentioned. Once an investigator begins assigning treatment, withdrawal of patients effectively destroys the study at that site. Thus, the event(s) that precipitate the FDA’s imposing a hold at a site must be compelling, since the action will result in negating all value of the site. 3) Overall we found the guidance to be reasonable and fair. We appreciated that it involved the sponsor in the decision to impose the hold. Thank you for the opportunity to comment on this draft guidance. Please let us know if you have any questions on our review. Sincerely, Jenny Peters/Pharmacia




EC -1