The School of Advanced Study is in Senate House or, if you’ve seen the film of George Orwell’s 1984 starring John Hurt, the Ministry of Truth, fitting perhaps for a conference considering the modern information environment where science communication vies online with “fake news”.
“There is a growing research literature suggesting psychedelics hold incredible promise for treating mental health ailments ranging from depression and anxiety to PTSD. But how do we know for sure?
The way forward for psychedelics is through “open science.” Researchers should pre-register their plans and share their data, as we have in our own research….”
Abstract: To ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance….
Results Of 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% v 11.0%, adjusted odds ratio 23.2, 95% confidence interval 19.2 to 28.2); as were trials by a sponsor who conducted a large number of trials (77.9% v 18.4%, adjusted odds ratio 18.4, 15.3 to 22.1). More recent trials were more likely to report results (per year odds ratio 1.05, 95% confidence interval 1.03 to 1.07). Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials.
Conclusions Compliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates.
“An analysis of data from the European Union’s Clinical Trial Register — published in The BMJ1 on 13 September — shows that around 50% of the listed trials have not complied with guidelines that say results must be reported within 12 months.
The researchers who conducted the analysis found that only 11% of trials run by academic centres — such as those led by universities, governments, hospitals or charities — had published outcomes after completion (see ‘Failing to comply’’)….
Furthermore, only 11 of the major sponsors of clinical trials — entities that are responsible for at least 50 trials on the register — had reported 100% of results, all of which were companies.
This compares to a total of 32 major sponsors that had not reported any results from their trials. All of these are academic institutions, rather than companies.”
“Cochrane is registered as a charity and is largely publicly funded; much of its data extraction and systematic review work is done by volunteers. However, Cochrane’s current policies allow only specific individuals with full library access to view and reuse data reports in their entirety. Cochrane has declined to allow data sharing for reuse through OpenTrials or the Trip Database library. However, data sharing is essential to transparency in research, the investigators wrote, and is associated with “increased citations…publications, and [data] reuse for new purposes.” In addition, improved access to existing data allows investigators to refine extraction processes and explore “new avenues of inquiry.” …”
“One year after three UK public research funders agreed to adopt the WHO’s strong standards on clinical trial transparency, it appears that none of them has fully implemented their commitments.
Responses to Freedom of Information requests filed by TranspariMED indicate that two funders, MRC and NIHR, have taken significant steps towards greater transparency, but still fall short of fully delivering on the promises they made. The third funder, DFID, has taken no action to meet its commitments….”
“OICR-funded drug discovery project’s unique ‘open science’ business model is accelerating the search for a solution to lethal pediatric brain cancers Diffuse intrinsic pontine glioma (DIPG) is a lethal and inoperable brain cancer with a median survival of less than a year from diagnosis. Finding solutions to this disease is challenging due to its rarity, scientific complexity and its presentation in pediatric populations. An OICR-funded team of researchers, led by Dr. Aled Edwards from M4K Pharma, have developed new potential drug candidates for DIPG that they will test in animal models in the coming months. They’ve reached this milestone ahead of schedule, with fewer resources required than anticipated, by using an ‘open drug discovery’ approach – sharing their methods and data with the greater research community to streamline the drug discovery process….”
“This website, originally created in a collaboration between The British Pharmacological Society (BPS) and the International Union of Basic and Clinical Pharmacology (IUPHAR) and now developed jointly with funding from the Wellcome Trust, is intended to become a “one-stop shop” portal to pharmacological information. One of the main aims is to provide a searchable database with quantitative information on drug targets and the prescription medicines and experimental drugs that act on them….The Guide to PHARMACOLOGY database is licensed under the Open Data Commons Open Database License (ODbL). Its contents are licensed under the Creative Commons Attribution-ShareAlike 3.0 Unported license….”
“Objectives To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies’ commitments, and to assess concordance with ethical and professional guidance….
Results Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately.
Conclusions The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice were met by at least one company, showing that these commitments are realistic targets.”