Clinical trials information in drug development and regulation (original) (raw)
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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...
Clinical Trial Data Transparency in the EU: Is the New Clinical Trials Regulation a Game-Changer?
IIC - International Review of Intellectual Property and Competition Law
The benefits of access to clinical trial data are related to their inestimable value from the perspective of clinical trial participants, society as a whole, public health systems and scientific progress. In light of the development of innovative data analysis technologies, access to raw clinical trial data opens up an ever-widening array of possibilities: it can profoundly facilitate machine data analysis for, inter alia, hypothesis generation, risk modelling, counterfactual simulation and – finally – drug repurposing and development. The enactment of the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) and introduction of the Clinical Trials Information System (CTIS) were heralded as ensuring a level of transparency in clinical trials that is sufficient to contribute to protecting public health and fostering the innovation capacity of European medical research, while recognizing the legitimate economic interests of sponsors. This paper presents the hitherto binding rules for...
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 ...
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...
BMJ Evidence-Based Medicine
Clinical trial sponsors have ethical obligations to register protocols, report study results and comply with applicable legal requirements. To evaluate public commitments to trial disclosure and rates of disclosure by members and non-members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA). Websites of the top 50 biopharmaceutical companies by 2015 sales were searched for statements relating to trial data disclosure. Disclosure of trial results completed by biopharmaceutical industry and non-industry sponsors of at least 30 trials (2006–2015) was assessed using TrialsTracker. Among the top 50 companies, 30 were EFPIA/PhRMA members and 20 were non-members, of which 26 and none, respectively, had a statement on their website committing to the disclosure of trials data. Of 29 377 trials in TrialsTracker, 9511 were industry sponsored (69 companies) and 19 866 were non-industry sponsor...
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...
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.
Data Standardization, Pharmaceutical Drug Development, and the 3Rs
ILAR Journal, 2016
Despite the efforts, cost, and extensive use of animals for nonclinical research, only a small number of studies have methodically compared findings from animal toxicology studies to those from human clinical trials. Impediments to understanding the translation of nonclinical safety have included the lack of easy access to data and the need for extensive data curation given the diverse terminologies, formats, and data platforms in use. SEND and SDTM study data standards, developed by CDISC and about to become mandated by FDA, can address this and other drug development issues by facilitating access to data in ways that are not currently feasible. A consistent data standard across clinical and nonclinical will discourage the development of data silos, which easily become obstacles to data sharing and maximizing the value of animal and human data. The confluence of rapid scientific advances, increasingly larger quantities of diverse data, technological advances in data mining, and the FDA's requirements for standardized study data create new opportunities for the advancement of drug development and for refinement in the way we use animals.
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.