News

• • Clinical Trial Registry Errors Undermine Transparency. Data are reported on completion dates specifically. Reported by Catherine Offord in the Scientist.

  • 39% of U.S. clinical trial results are not made public. Study by Nelson and colleagues, 2023.

  • Telescope Intelligence report on "The state of global clinical trial disclosure. What noncompliance penalties are in place, and how they are enforced." Telescope Intelligence: 2023

  • Following widespread consultation, the UK government will introduce a law that the results of clinical trials must be made public within 12 months of completion. 21 March 2023. Details here.

  • "European Medicines Agency will resume making Clinical Study Reports available in 2023" (4 Jan 2023)

  • The UK Health Research Agency guidance on trial registration (5 May 2022)

  • Sense about Science reports that the UK MHRA has invited public views on making the registration of all clinical trials and results compulsory under UK law.

  • Transparimed article notes: (Nov 3 2021) that: UK clinical trial transparency system to go live in 2022

  • Transparimed article notes (Oct 6 2021) that: Most major European research institutions now uploading missing clinical trial results

  • Clinical trials transparency: follow-up inquiry - due to the general election on 12 December 2019 the Committee has now closed this inquiry see here. If an inquiry on this subject is held in the future, the Committee may refer to the evidence already gathered as part of this inquiry

  • Clinical trials transparency: follow-up - oral evidence (29 October 2019) transcript (pdf here) 

  • UK House of Commons Select Committee report on Research integrity: clinical trials transparency (30 Oct 2018).

  • A STAT investigation reports that trial sponsors disclose 72% of required results to ClinicalTrials.gov (Sept 2017), compared to 58% two years ago.

  • Discussion in JAMA of the availability of Clinical Study Reports via the European Medicines Agency and comparison to processes in the FDA (March 2017)

  • The US Department of Health and Human Services has issued its final rule for registering clinical trials involving FDA-regulated drugs, biological products and devices.  It also covers the provision of summary results for all NIH-funded trials to ClinicalTrials.gov.  Webinars on the Final Rule and ClinicalTrials.gov took place September and October 2016.

  • 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.

    • PLoS Med Commentary (2015)

  • HHS and NIH take steps to enhance transparency of clinical trial results.

    • NIH propose a policy to promote transparency for all NIH-funded trials (including those not subject to FDAAA).

• European Medicines Agency (EMA) released a new “Guide on access to unpublished documents.” (24 November 2014)

  • Commentary on BMJ Blogs

US National Institutes of Health (NIH) and the Food and Drug Administration (FDA) propose regulations to tighten reporting requirements for clinical trials (25 November 2014).

Project Data Sphere launched - (2014)

• Pharma companies and a medical research centre to provide access to data from the control/comparator groups of trials. Independent, not-for-profit. For data from academic and industry phase III cancer clinical trials.

NIHR invests in more transparency with own open access journals

• The National Institute for Health Research (NIHR) has announced the launch of the new NIHR Journals Library, which will provide open access to an extensive body of health research. A plain English summary will accompany each publication to  help patients, carers and relatives understand the research undertaken to improve care and treatment.

Plain English summaries for trials

• A commentary recently published in Trials examines a number of recent initiatives in the UK and explains how open access publisher BioMed Central is approaching the task.

Ok to ask - a new NIHR initiative (2015)

• The NIHR has launched the OK to ask about clinical research campaign to promote public and patient involvement in clinical research by encouraging them to ask about clinical trials. This campaign aims to demonstrate the potential benefits of participating in research studies including clinical trials and has already attracted over 150 hospitals to sign up.

Industry announces new clinical trial transparency measures (2013)

• The UK industry body ABPI appointed an independent third party service provider to monitor compliance to the clinical trial transparency provisions contained in the ABPI Code of Practice. news here

UK Parliament enquiry on clinical trials (2013)

• A number of organisations have given evidence to the House of Commons regarding the impact of the revised European Clinical Trials Directive on conducting trials in the UK, the role of the Health Research Authority and barriers to transparency and disclosure of clinical trials. More information here.

British Medical Journal launches website as part of a campaign urging Roche to release efficacy data on oseltamivir (Tamiflu) (2012)

• The British Medical Journal, as part of its ongoing open data campaign, has launched a dedicated website aimed at persuading Roche to give doctors and patients access to the full data on the safety and efficacy of oseltamivir (Tamiflu).  

• Transparency for clinical trials - the TEST ACT (USA) (2013)

  • The Trial and Experimental Studies Transparency (TEST) Act (HR 6272) has allowed some entities to conduct clinical trials without registering them or reporting the results.The TEST Act would expand reporting requirements under existing US law by broadening the scope to include all interventional studies of drugs or devices, regardless of phase, design or approval status.