A central online news resource for professionals involved in the development of medical publications and involved in publication planning and medical writing.
The FDAAA 2007 requires clinical trials to make results publicly available 12 months after study completion. A new tool from TrialsTracker provides a live online report on compliance.
Missed TIPPA 2018? Read our meeting report to get up to speed!
Missed ISMPP EU 2018? Duncan Campbell provides a summary of day 2 of the meeting.
Missed ISMPP EU 2018? Read our meeting report to get up to speed!
Integrity and transparency are paramount to the accuracy, accessibility and credibility of medical research. Given that clinical evidence informs market approval of medical products, missing or inaccurate clinical trial data … Continue Reading Three steps to transparency in clinical research: a new white paper from the Collaboration for Research Integrity and Transparency
The ongoing push towards increased transparency around clinical trials has seen the evolution of regulatory requirements for data reporting and sharing in Europe and the US over the past decade. … Continue Reading The evolution of regulations for improved clinical trial transparency
Over two days last week (17-18 January, 2017), around 250 delegates and exhibitors attended the 2017 European meeting of the International Society for Medical Publication Professionals (ISMPP) in London. The … Continue Reading Meeting report: Summary of Day 1 of the 2017 European #ISMPP Meeting
Despite regulatory requirements and industry commitments, analyses of clinical trial transparency rates continue to report that not all clinical trial results are published within the required timelines, or at all. … Continue Reading Company-sponsored clinical transparency rates continue to improve
It has been suggested that a sizeable number of registered clinical trials fail to report their results, and that negative or null results are especially likely to remain unpublished. To help tackle … Continue Reading TrialsTracker attempts to identify trials with potentially unreported results
At this year’s World Health Summit in Berlin, a beta version of OpenTrials, an online database containing information on clinical trials from across the world, was officially launched. The project, … Continue Reading OpenTrials launches beta version of online database
The sharing of patient-level data between research groups and pharmaceutical companies has the potential to generate enormous benefits for health. However, in an article published in the BMJ, Elizabeth Pisani … Continue Reading Shared data: accessible, useable or useful?
It is a legal requirement for those responsible for certain applicable clinical trials of FDA-regulated products to register the studies on ClinicalTrials.gov and report results within a defined timeframe, as … Continue Reading Final rule clarifies and expands results reporting requirements of the FDA Amendments Act
The push for transparency of clinical trial data has gathered momentum over recent years. The World Health Organization (WHO) has called for journal submission of trial results within one year … Continue Reading Is the timely publication of clinical trial results a reality?
In January of this year, the International Committee of Medical Journal Editors (ICMJE) outlined a proposal to share non-personalised data from clinical trials within 6 months of the publication of … Continue Reading Researchers do not fully support the ICMJE proposals on data sharing
Many organisations and journals advocate the sharing of individual patient-level clinical data to facilitate additional analyses and increase transparency around clinical trials. Are the current strategies for facilitating data sharing … Continue Reading Improving data sharing for the advancement of research
Have you ever questioned the validity of clinical trials data? ClinicalTrials.gov is a searchable registry and database of clinical trials. It is run by the National Library of Medicine (NLM) … Continue Reading Comparing clinical trial results from two searchable registries