Public Disclosure of Clinical Trial Results: A Necessary Step on the Path to Transparency and Trust
Source: Pharmaceutical Medicine, Volume 23, Number 3, 1 June 2009 , pp. 131-137(7)
Publisher: Adis International
Abstract:A premise of modern medical practice is that scientific knowledge about health and disease - and the thoughtful application of this information by healthcare providers and patients - will improve health and well-being. Informed decisions about healthcare, and our desire to advance the fight against illness, are dependent upon the availability of complete and reliable scientific information about disease signs and symptoms, preventative measures and treatment options. Much of the recent public dialogue about the availability of information from clinical research has coalesced around the term `transparency', a word that evokes notions of openness and communication and is commonly allied with ideals of responsibility and public accountability. This article discusses the drive for transparency in relation to clinical research and highlights that the needs of patients, healthcare practitioners and researchers may differ substantially. This article also reviews accomplishments to date and suggests what, in our opinion, is next on the horizon, including some of the significant policy and logistical issues likely to emerge as clinical researchers continue on the journey of transparency.This article includes the recent history around protocol registration, posting of clinical trials results, and the interplay between those activities and the traditional methods of scientific disclosure through the peer-reviewed scientific literature. While the debate around the best way forward in public disclosure of results from all trials of available medical therapies is far from over, it is clear that the next round of debates on refining and expanding the scope of the activity has already begun and there are significant questions that remain. In particular, how can all the scientific information that is being made publicly available - in registers, abstracts and manuscripts- be evaluated, summarized and delivered in a fashion that truly informs healthcare providers and patients? Enhanced transparency is a necessary step on the path to providing meaningful information to physicians and patients, but there is much to do to optimize the translation of the results of medical research into medical practice and to advance medical science in a timely manner.
Document Type: Research article
Affiliations: 1: 1 Drug Development Sciences, GlaxoSmithKline, King of Prussia, Pennsylvania, USA 2: 2 Office of the Chief Medical Officer, GlaxoSmithKline, Uxbridge, UK 3: 3 Global Centre of Excellence for Drug Discovery, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
Publication date: 2009-06-01