UK COMMISSION CALLS FOR NEW PHASE I CLINICAL TRIAL RULES

A UK governmental commission has called for the establishment of an open-access database of information for certain high-risk Phase I clinical trials, along with 21 other recommendations that are intended to prevent any repeat of the catastrophic Phase I clinical trial of the gene therapy TGN1412.

In that trial six healthy young male volunteers fell critically ill within hours of taking the drug in March, leading to the bankruptcy of the sponsor, TeGenero.

The Expert Scientific Group was convened by the UK's Secretary of State for Health to examine the rules for Phase I trials of biologic molecules with novel mechanisms of action, new agents with a high degree of species-specificity and new agents with immune system targets.

These are generally considered to be especially high risk, but the report recommends that "a thorough assessment of risk should always be carried out before first-in-man trials. The risk assessment should be clearly described in the trial documents and be fully examined by the regulator. When there is significant doubt, higher risk should always be assumed."

The report called the establishment of an open-access database an "ultimate goal," and said that until this can be done, "reports from studies that would otherwise not be in the public domain could initially be stored in a secure database accessible only to regulators worldwide, with frequent review of the reason for delaying open access."

"Clinical trials in general have an excellent safety record, but it is important that we learn the lessons from the TGN1412 incident to optimize the safety of future Phase I studies, particularly those involving these novel medicines." Kent Woods, chief executive of the MHRA, said.

The report can be viewed at www.dh.gov.uk/PublicationsAndStatistics/Publications/
PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4141039&chk=Qczxoq.