Ronald Krall, chief medical officer of GlaxoSmithKline, chairs GSK’s Global Safety Board and has responsibility for monitoring the safety of GSK medicines, managing regulatory affairs, and dealing with policy questions related to R&D. A neurologist by training, he has led drug-development programs in various therapeutic areas during his more than two decades in the pharmaceutical industry. He has thus confronted a vexing issue now debated in the public forum: How, or whether, to make still experimental, unproven drugs available to desperate patients. The matter is the subject of legislation in the US Congress and of proposed regulatory changes at the US Food and Drug Administration (FDA).
In a video, Krall speaks of this dilemma.
Krall also notes the response of the Society for Clinical Trials (PDF 342Kb) to a congressional bill. The response is made available here by courtesy of the journal Clinical Trials; one of the authors is Frank Rockhold, who heads Biomedical Data Sciences at GSK. For further information, read also the FDA’s proposed rules. Patients interested in participating in clinical trials can check a registry of active studies compiled by the National Library of Medicine for the US National Institutes of Health.
