Clinical trials revolution could change the future of medical research | Science | The Guardian

“In tumultuous times, it is easy to miss the fact that science is undergoing a quiet revolution. For several years now, concerns have been peaking in biomedicine about the reliability of published research – that the results of too many studies cannot be reproduced when the methods are repeated. Alongside growing discontent, the scientific community has answered by driving forward a raft of open science reforms. From initiatives to making research data publicly available, to ensuring that all published research can be read by the public, the aim of these reforms is simple: to make science more credible and accessible, for the benefit of other scientists and the public who fund scientific research.”

WHO | Major research funders and international NGOs to implement WHO standards on reporting clinical trial results

“Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.”

Journal of Health Psychology

Abstract: “Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.”

Journal of Health Psychology

Abstract: “Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.”

Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis | Systematic Reviews | Full Text

Abstract: “The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.”

Elizabeth Warren demands open access to clinical trial data

“Should researchers make public all the data they collect when testing drugs and medical devices on patients?

That’s been a hot question in the scientific community for years — and as debate intensified this week, an unlikely voice weighed in on the side of opening data to all: Massachusetts Senator Elizabeth Warren.”

Opening up Malaria Research by Patrick Vallance and Tim Wells – Project Syndicate

“In recent years, tremendous progress has been made in the battle against malaria. According to the World Health Organization, the number of deaths from the disease has fallen by a staggering 60% since 2000 – the result of improved access to diagnostic testing and treatment. To be sure, there is still considerable work to be done, but the downward trend in new infections and deaths underscores the power of collaboration among governments (in malaria endemic and non-endemic countries alike), between commercial and non-profit organizations, and between academic science and medicine. Without such partnerships, advances in fighting this deadly disease would not have been possible. Alongside coordinated action on the ground, increasing openness and collaboration among scientists researching and developing a new generation of medicines and vaccines is paving the way for further progress …”