Characteristics of mental health trials registered in ClinicalTrials.gov – ScienceDirect

Abstract:  The ClinicalTrials.gov registry was established in 2000 to address concerns about publication bias and public access to information about clinical trials. We aimed to evaluate differences between for-profit and non-profit sponsors of efficacy mental health trials registered in ClinicalTrials.gov on key trial characteristics that relate to data integrity. We also sought to evaluate whether the registry is fulfilling its purpose as a means of promoting transparency between researchers and the public by providing complete and quality information about the trials it contains. We found that trials tend to be small, use a placebo instead of an active comparator, and employ randomization and blinding. We discuss the implications of these design characteristics and the limitations of the registry.

 

Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says – The New York Times

“After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H.I.V. with a daily pill.

The suit, by the Department of Health and Human Services, came as a pleasant shock to many critics of the company, including Democratic members of Congress who had pressed the administration to act.

It is very rare for the government to take on a drug maker over patents. But the medications made by Gilead are necessary to end the AIDS epidemic by 2030, which the Trump administration has set as a goal. That cannot be accomplished if the drugs are not made more affordable….”

Open Systems Pharmacology community – an open access, open source, open science approach to modeling and simulation in pharmaceutical sciences. – PubMed – NCBI

Abstract:  Systems Pharmacology integrates structural biological and pharmacological knowledge and experimental data enabling dissection of organism and drug properties and providing excellent predictivity. The development of systems pharmacology models is a significant task requiring massive amounts of background information beyond individual trial data. Qualification of models needs repetitive demonstration of successful predictions. Open Systems Pharmacology is a community that develops, qualifies and shares professional open source software tools and models in a collaborative open science way.

Position statement on open access – Open Pharma

“Our immediate priority is to secure authors publishing company-funded research the same right to publish open access as authors publishing research funded by other sources, so that all research can be made free to read from the date of publication. This would enable pharmaceutical companies to follow the lead of other research funders in requiring all the research they fund to be published with open access, without impacting on journal choice.5-7 In order to provide publishers the time to adapt their policies and protect their copyright interests, any variant of Creative Commons or equivalent licence could be used….

Our long-term goal is to secure authors publishing company-funded research the same terms as authors publishing research funded by other sources, so that all research can be made free to read – and reuse – from the date of publication….”

Frequency and format of clinical trial results dissemination to patients: a survey of authors of trials indexed in PubMed

Abstract:  Objective Dissemination of research findings is central to research integrity and promoting discussion of new knowledge and its potential for translation into practice and policy. We investigated the frequency and format of dissemination to trial participants and patient groups. Design Survey of authors of clinical trials indexed in PubMed in 2014–2015. Results Questionnaire emailed to 19 321 authors; 3127 responses received (16%). Of these 3127 trials, 2690 had human participants and 1818 enrolled individual patients. Among the 1818, 498 authors (27%) reported having disseminated results to participants, 238 (13%) planned to do so, 600 (33%) did not plan to, 176 (10%) were unsure and 306 (17%) indicated ‘other’ or did not answer. Of the 498 authors who had disseminated, 198 (40%) shared academic reports, 252 (51%) shared lay reports, 111 (22%) shared both and 164 (33%) provided individualised study results. Of the 1818 trials, 577 authors (32%) shared/planned to share results with patients outside their trial by direct contact with charities/patient groups, 401 (22%) via patient communities, 845 (46%) via presentations at conferences with patient representation, 494 (27%) via mainstream media and 708 (39%) by online lay summaries. Relatively few of the 1818 authors reported dissemination was suggested by institutional bodies: 314 (17%) of funders reportedly suggested dissemination to trial participants, 252 (14%) to patient groups; 333 (18%) of ethical review boards reportedly suggested dissemination to trial participants, 148 (8%) to patient groups. Authors described many barriers to dissemination. Conclusion Fewer than half the respondents had disseminated to participants (or planned to) and only half of those who had disseminated shared lay reports. Motivation to disseminate results to participants appears to arise within research teams rather than being incentivised by institutional bodies. Multiple factors need to be considered and various steps taken to facilitate wide dissemination of research to participants.

ASTRO Journals’ Data Sharing Policy and Recommended Best Practices- ClinicalKey

Abstract:  Transparency, openness, and reproducibility are important characteristics in scientific publishing. Although many researchers embrace these characteristics, data sharing has yet to become common practice. Nevertheless, data sharing is becoming an increasingly important topic among societies, publishers, researchers, patient advocates, and funders, especially as it pertains to data from clinical trials. In response, ASTRO developed a data policy and guide to best practices for authors submitting to its journals. ASTRO’s data sharing policy is that authors should indicate, in data availability statements, if the data are being shared and if so, how the data may be accessed.

 

Canada Opens the Door to Public Scrutiny of Clinical Drug Trials

“This past March, Canada’s department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one. For the first time, Health Canada is making large chunks of this information publicly available after it approves or rejects applications.

Within 120 days of a decision, Health Canada will post clinical study reports on a new government online portal, starting with drugs that contain novel active ingredients and adding devices and other drugs over a four-year phase-in period. These company-generated documents, often running more than 1,000 pages, summarize the methods, goals, and results of clinical trials, which test the safety and efficacy of promising medical interventions. The reports play an important role in helping regulators make their decisions, along with other information, such as raw data about individual patients in clinical trials.

So far, Health Canada has posted reports for four newly approved drugs — one to treat plaque psoriasis in adults, two to treat two different types of skin cancer, and the fourth for advanced hormone-related breast cancer — and is preparing to release reports for another 13 drugs and three medical devices approved or rejected since March.

Canada’s move follows a similar policy enacted four years ago by the European Medicines Agency (EMA) of the European Union. The U.S. Food and Drug Administration (FDA), on the other hand, continues to treat this information as confidential to companies and rarely makes it public….”

Frequency and format of clinical trial results dissemination to patients: a survey of authors of trials indexed in PubMed | BMJ Open

Abstract:  Objective Dissemination of research findings is central to research integrity and promoting discussion of new knowledge and its potential for translation into practice and policy. We investigated the frequency and format of dissemination to trial participants and patient groups.

 

Design Survey of authors of clinical trials indexed in PubMed in 2014–2015.

 

Results Questionnaire emailed to 19?321 authors; 3127 responses received (16%). Of these 3127 trials, 2690 had human participants and 1818 enrolled individual patients. Among the 1818, 498 authors (27%) reported having disseminated results to participants, 238 (13%) planned to do so, 600 (33%) did not plan to, 176 (10%) were unsure and 306 (17%) indicated ‘other’ or did not answer. Of the 498 authors who had disseminated, 198 (40%) shared academic reports, 252 (51%) shared lay reports, 111 (22%) shared both and 164 (33%) provided individualised study results. Of the 1818 trials, 577 authors (32%) shared/planned to share results with patients outside their trial by direct contact with charities/patient groups, 401 (22%) via patient communities, 845 (46%) via presentations at conferences with patient representation, 494 (27%) via mainstream media and 708 (39%) by online lay summaries. Relatively few of the 1818 authors reported dissemination was suggested by institutional bodies: 314 (17%) of funders reportedly suggested dissemination to trial participants, 252 (14%) to patient groups; 333 (18%) of ethical review boards reportedly suggested dissemination to trial participants, 148 (8%) to patient groups. Authors described many barriers to dissemination.

 

Conclusion Fewer than half the respondents had disseminated to participants (or planned to) and only half of those who had disseminated shared lay reports. Motivation to disseminate results to participants appears to arise within research teams rather than being incentivised by institutional bodies. Multiple factors need to be considered and various steps taken to facilitate wide dissemination of research to participants.

Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence | Electronic Health Records | JAMA Network Open | JAMA Network

“Question  What percentage of clinical trials published in high-impact journals in 2017 generated evidence that could feasibly be replicated using observational methods and data sources?

Findings  In this cross-sectional study of 220 clinical trials published in high-impact journals in 2017, only 15% could feasibly be replicated using currently available real-world data sources.

Meaning  This study suggests that, although the increasing use of real-world evidence in medical research presents opportunities to supplement or even replace some clinical trials, observational methods are not likely to obviate the need for traditional clinical trials….”

SUPP.AI by AI2

“Dietary and herbal supplements are popular but unregulated. Supplements can interact or interfere with the action of prescription or over-the-counter medications. Currently, it is difficult to find accurate and timely scientific evidence for these interactions.

To solve this problem, Supp.AI automatically extracts evidence of supplement and drug interactions from the scientific literature and presents them here….

To find out more about this work, please read our publication….

Supp.AI is a free service of the non-profit Allen Institute for AI….”