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Weekly UpdatesThe following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in June 2007. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W, etc.). Copies of responses to the letter, along with any 483s and EIRs, are available from RECORD-RETRIEVE: (703) 779-8777, or SERVICE@FDAINFO.COM.
An investigation was conducted to review the protocol entitled "A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and tolerability in the treatment of manic episodes of bipolar I disorder over 3 weeks" of the investigational drug. The investigation found that there was a failure to adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.
However, one subject asked to leave the study and her request was denied and the subject was only allowed to discontinue after her lawyer signed the subject out of the facility.
Linden failed to obtain informed consent of subjects involved in the research, specifically one subject was randomized in this double blind placebo controlled study drug. However, the subject did not sign a consent form to participate in this study. Instead, the subject signed a consent form to participate, in an open label study, the letter noted.
Another instance showed that a blood sample was drawn from a subject for pharmacogenetic analysis. However, this subject did not sign the protocol required consent form to participate in the pharmacogenetic component of the study. Also, subjects did not sign current IRB-approved versions of the consent form that contains additional information pertaining to risk.
In another case, the protocol states that "every serious adverse event (SAE) occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported within 24 hours of learning of its occurrence." However, this was not completed. Doc. 14214W
The letter stated David Linden, M.D., failed to protect the rights, safety, and welfare of subjects. For example, the consent form specified, "your participation in this research is voluntary. You may refuse to enroll, or change your mind at anytime."
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