Collections of COVID-19 trials
RIAT: restoring invisible and abandoned trials
International Committee of Medical Journal Editors (ICMJE) has published a proposal for sharing clinical trial data (2 Feb 2016) and invite feedback. The proposal is that as a condition of consideration for publication of a clinical trial report in member journals, the ICMJE will ask authors to share the deidentified individual-patient data underlying the results no later than 6 months after publication.
The BMJ requires data sharing on request for all trials (7 May 2015)
WHO statement on public disclosure of trial results: trials should be registered on public registry, updated and main findings of trials should be submitted for publication in a peer reviewed journal within 12 months of completion.
Pharmaceutical companies: Principles for responsible clinical trial data sharing
This document was published in July 2013 and sets out biopharmaceutical companies approaches to sharing trial results for medicines and indications approved in the USA and the European Union. The document comes into effect on the 1 Jan 2014.
The Green Park Collaborative (GPC)
The GPC is an international initiative developing guidance for the life science industry on clinical trials designs to meet the needs of Health Technology Assessment (HTA) organisations and coverage bodies. The guidance seeks to reduce the uncertainty faced by the life sciences industry regarding what evidence is required by HTA and coverage bodies. Guidance seeks to improve the relevance of clinical research, and patient access to innovations.
New CONSORT statement noted in BMJ
The British Medical Journal (BMJ) has noted that a fragmented and bureaucratic system surrounds clinical trials, which is preventing patients from receiving life-saving treatments not yet available on the NHS. A Guardian article that reported these findings went on to further report that the editor of the BMJ (Dr. Fiona Godlee) suggested that patients are relying on staff from both voluntary organisations and patient groups to pass on information regarding clinical trials.
European Union
BMJ editorial: big strides in Europe towards clinical trials transparency.
"Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament on Wednesday. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments, e.g. for rare diseases."
European Commission Regulation of July 2012 is approaching agreement and is likely to permit submission of trial requests through a single portal.
Steinbrook R. The European Medicines Agency and the Brave New World of Access to Clinical Trials Data. Arch Intern Med. 2012;():1-2.
Doshi P, Jefferson T. The first 2 years of the European Medicines Agency’s policy on access to documents: Secret no Longer. Arch Intern Med. 2012;():1-2.
Mauritius - Clinical Trials Act 2010
In 2010, the government of Mauritius introduced the Clinical Trials Act to provide a legal framework to conduct research in the country.