Commitments by the biopharmaceutical industry to clinical trial transparency: the evolving environment (original) (raw)
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BMJ Open
ObjectiveTo evaluate the accuracy of a 2015 cross-sectional analysis published in theBMJ Openwhich reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies.DesignWe performed a reassessment of the data reported in Milleret alto evaluate whether statutory compliance analyses and conclusions were valid.Data sourcesInformation from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors.Main outcome measuresCompliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA).ResultsIndustry compliance with FDAAA disclosure requirements was notably higher than reported by Milleret al.Among trials subject to FDAAA, Milleret alreported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results re...
BMJ open, 2017
To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of ...
Pharmaceutical Statistics, 2011
Since the web-based registry ClinicalTrials.gov was launched on 29 February 2000, the pharmaceutical industry has made available an increasing amount of information about the clinical trials that it sponsors. The process has been spurred on by a number of factors including a wish by the industry to provide greater transparency regarding clinical trial data; and has been both aided and complicated by the number of institutions that have a legitimate interest in guiding and defining what should be made available. This article reviews the history of this process of making information about clinical trials publicly available. It provides a reader's guide to the study registries and the databases of results; and looks at some indicators of consistency in the posting of study information.
Medicine Access @ Point of Care
The European legislative framework is quickly moving towards transparency of the clinical trials data. The European Medicines Agency (EMA)'s Policy/0070, entered into force on January 1, 2015, marked a complete change of approach, moving from a reactive access, upon any interested parties' request, to a proactive publication of the clinical trials data. This approach will be further straightened with the entry into force of Regulation (EU) No. 536/2014 on clinical trials (CT Regulation), expected in 2019, following the activation of the European portal and database. The purpose of ensuring the transparency of the clinical trials data has to be balanced with compelling interests, including, in particular, the protection of the commercially confidential information (CCI) of the sponsors. The criteria to identify what data shall be considered as CCI and what specific reasons might be given by sponsors to support a request for keeping certain data confidential are not clearly st...
Reporting clinical trials: Full access to all the data
Annals of Neurology, 2002
Biomedical research is becoming more complex as a result of involvement by individual investigators, universities, commercial research units, and industry. Financial conflicts of interest have been the subject of many editorials, and most peer-reviewed journals now require authors to identify and explain any conflicts when submitting manuscripts for publication. Clear statements of industry-sponsored research and author participation in corporate activities are required for evaluation of a manuscript. Full disclosure of financial interests by authors is essential to retain public trust in biomedical research, the peer-review process, and the integrity of the authors and universities. 1 We already require that each author sign a statement of his or her financial arrangements with public, private, and industry sources of support. These declarations alert the editor, reviewer, and physician-reader to any potential bias in the interpretation and presentation of the data. Patients' lives may depend on an accurate and complete understanding of how and why authors obtained facts relating to therapies. Non-financial conflicts of interest between authors and corporate sponsors are of equal concern and require our attention. These include the need for an open and candid relationship between authors and the policies of the sponsoring companies with regard to academic freedom. Issues of control and complete access to all data, conduct of statistical studies and analyses, manuscript preparation, and decisions to publish are of increasing importance and concern.
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access
Revista panamericana de salud pública = Pan American journal of public health, 2015
In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders (i.e., patients, prescribers, government, society, industry, and regulators). Additionally, the social, technical, and ethical aspects of the datasharing process are highlighted, including access limits, commercially-confidential data and patent rights, privacy of research subjects, arrangements and publicity tools, and clinical trials registration. Furthermore, perspectives on improvement and expansion of regulatory transparency policies are presented, contextualizing North American, Latin American, and European experiences, and highlighting in-teragency cooperation and collaboration initiat...
BMJ, 2019
Objectives To develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial data sharing policies and practices. Design Cross sectional descriptive analysis. Setting Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. Data sources Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. Main outcome measures Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial...
Pharmaceutical Statistics, 2013
f on behalf of the EFSPI The European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) believes access to clinical trial data should be implemented in a way that supports good research, avoids misuse of such data, lies within the scope of the original informed consent and fully protects patient confidentiality. In principle, EFSPI supports responsible data sharing. EFSPI acknowledges it is in the interest of patients that their data are handled in a strictly confidential manner to avoid misuse under all possible circumstances. It is also in the interest of the altruistic nature of patients participating in trials that such data will be used for further development of science as much as possible applying good statistical principles. This paper summarises EFSPI's position on access to clinical trial data. The position was developed during the European Medicines Agency (EMA) advisory process and before the draft EMA policy on publication and access to clinical trial data was released for consultation; however, the EFSPI's position remains unchanged following the release of the draft policy. Finally, EFSPI supports a need for further guidance to be provided on important technical aspects relating to re-analyses and additional analyses of clinical trial data, for example, multiplicity, meta-analysis, subgroup analyses and publication bias.
BMJ open, 2015
To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32-83%) of trials were registered, 20% (IQR 12-28%) reported results in ClinicalTrials.gov, 56% (...
Trials, tricks and transparency: how disclosure rules affect clinical knowledge
2008
Abstract Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined the need for more transparency in clinical trials. We provide a theoretical framework which reproduces incentives for selective reporting and yields three key implications concerning regulation. First, a compulsory clinical trial registry complemented through a voluntary clinical trial results database can implement full transparency (the existence of all trials as well as their results is known). Second, full transparency comes at a price. It has a deterrence effect on the incentives to conduct clinical trials, as it reduces the firms' gains from trials.