Big Pharma has failed: the antibiotic pipeline needs to be taken under public ownership

“Looking into the past shows that public ownership of antibiotic R&D is not as radical as it may sound. During the second world war, allied research on penicillin – the most iconic antibiotic – was publicly financed, organised and owned. In fact, the original penicillin was never patented….”

Sharing Clinical Trial Data: Challenges and a Way Forward – A Workshop : Health and Medicine Division

“An ad hoc planning committee under the auspices of the National Academies of Sciences, Engineering, and Medicine, will plan and conduct a two-day public workshop to discuss advances, challenges, and opportunities in clinical trial data sharing efforts since the release of the 2015 Institute of Medicine report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. This workshop is co-sponsored by the Wellcome Trust.

WORKSHOP OBJECTIVES:

Consider the value and potential risks/costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, primary and secondary researchers, and patients;
Review the current landscape of clinical trial data sharing and reuse across public and private sectors (e.g. policies, platforms, collaborations, data sharing culture, published research output);
Examine use cases and trends from across public and private sectors when it comes to success, failure, lessons learned, and value;
Consider the perspectives and expectations of primary and secondary researchers, clinical trial participants, patient organizations, research sponsors (pharmaceutical companies and nonprofit organizations), journals, institutions, and federal agencies; and
Discuss next step opportunities for stakeholders to better harmonize incentives, policy, data standards, and governance to encourage the sharing and reuse of clinical trial data.

The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines….”

Data sharing from clinical trials: lessons from the YODA Project – STAT

“This week, the National Academies of Science, Engineering, and Medicine are convening the workshop “Sharing Clinical Trial Data: Challenges and a Way Forward” just shy of five years after the Institute of Medicine released its seminal report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.”

During this time, the scientific culture regarding data sharing has shifted. Just last week, the National Institutes of Health requested public comments on its draft “Policy for Data Management and Sharing.” In 2018, the International Committee of Medical Journal Editors began requiring data-sharing plans for clinical trials as a condition for publication in member journals. And platforms such as ClinicalStudyDataRequest.com, Project Data Sphere, and BioLINCC have emerged or grown. These platforms use a variety of different governance structures and models for data access, developed both with and without the support of industry or government….

The Yale Open Data Access (YODA) Project, which two of us (J.S.R. and H.M.K.) co-direct, launched in 2011 and formed a partnership with Johnson & Johnson in 2014. This five-year partnership offers an opportunity to reflect on some of the questions about sharing clinical trial data that may inform ongoing and future efforts….”

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….”