New FDA rule on clinical trial subjects

The FDA announced today that it is amending regulations governing INDs to permit the agency to place a clinical hold on one or more studies under an IND "if men or women with reproductive potential who have the diseaser condition are otherwise eligible but are categorically excluded from participation solely because of a perceived risk or potential risk of reproductive or developmental toxicity from use of the investigational drug."

The new rule was developed in response to the past practice of excluding women with reproductive potential from early clinical trials because of a perceived risk or potential risk of reproductive or developmental toxicity. Noting that investigational drugs can be teratogenic, the new rule allows sponsors and Institutional Review Boards to take steps to minimize fetal exposures, such as requiring the use of contraceptives and/or pregnancy testing to detect unsuspected pregnancy prior to initiation of study treatment and at intervals during the course of drug exposure. The rule also includes exceptions for special circumstances, including studies pertinent to only one gender such as those to evaluate the excretion of a drug in semen or its effects on menstrual function. FDA also stated that a clinical hold will not be applied to a clinical study conducted in men, as long as a study that does not exclude subjects with reproductive potential has been planned or is being conducted in women. ...