Clinical Trial Data as a Public Good

Rodwin, Marc A.; Abramson, John

doi:10.1001/jama.2012.9661

Cited by 35 publications

(26 citation statements)

References 8 publications

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“…In particular, one important driver of EMA's transparency policies is the understanding that 'outsiders' both want and require all relevant information on the safety of medicines (e.g. for empowerment) (Section 2) (Rodwin and Abramson, 2012;EMA, 2014b (Bonini et al, 2014). Respondents' broad desire for more information is therefore closely aligned with the underlying rationale of EMA's transparency policies, which serves to provide outsiders with as much information as (feasibly) possible about the agency's scientific and non-scientific activities.…”

Section: (51) the Provision Of More Information For Patients Is Neededmentioning

confidence: 99%

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Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

Way

Bouder

Löfstedt

et al. 2016

Journal of Risk Research

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The concept of transparency has gained widespread appeal in the European pharmaceutical domain, not least at the European Medicines Agency (EMA). Agency policies have two main objectives: (1) to enable the re-use of data (e.g. clinical study reports) and (2) to empower patients to directly and indirectly make more informed decisions on medicines. Past research has almost exclusively focused on the perspectives of external researchers intending to reanalyse data made publically available. Few studies, however, have explored what can be learnt from the perspectives of other actors (e.g. healthcare professionals, patients, the regulators themselves, industry and others). This empirical study explores the EMA's transparency policies from the perspectives of patients. After presenting the results of a survey (N=1010) with a sample of individuals diagnosed with five specific medical conditions (HIV/AIDS, multiple sclerosis, rheumatoid arthritis, osteoporosis, idiopathic pulmonary fibrosis) from four EU countries (Germany, Spain, France and the UK), the authors argue that EMA's transparency policies do not adequately address the real-world complexities of communicating with patients. In turn, the paper concludes that the perspective of patients provides an essential contribution to understanding the full net effects (positive, negative, limited) of EMA's transparency policies. Keywords: Transparency; patients; European Medicines Agency; pharmaceutical regulationThis is an accepted manuscript of an article published by Taylor & Francis in the Journal of Risk Research on 12/07/2016, available online: http://www.tandfonline.com/doi/full/10.1080/13669877.2016.1200652 (1). IntroductionOver the past 20 years, the European Medicines Agency (EMA), the decentralised European Union (EU) body responsible for the scientific evaluation of medicines developed by pharmaceutical companies 1 , has introduced many policies aimed at enhancing 'transparency' (EMA, 2009(EMA, , 2015a. In this risk regulation context, transparency can broadly be defined as "the conduct of [regulation] in a fashion that makes decisions, rules and other information visible from the outside" (Hood, 2010: 989). EMA's policies have overwhelmingly focused on publishing increasing quantities of information online regarding a wide range of its scientific and non-scientific activities (EMA, 2009, 2015a), or what Meijer (2009 describes as "computer-mediated" transparency. The 'objects' of transparency (see Heald, 2006a: 30-32) at EMA have included, but are not limited to, documents that provide the basis for decisionmaking in the Agency's seven scientific committees (i.e. policy inputs) (EMA, 2014a(EMA, , 2014b, management board and scientific committee meeting minutes (i.e. policy processes) (EMA, 2015a) and summaries of both its positive and negative opinions on medicines (i.e. policy outputs) (EMA, 2015a).Although many reasons for enhancing transparency at EMA have been debated in the medical literature (Hampton, 2012;Doshi et al., 2012;Groves and Godlee...

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Section: (51) the Provision Of More Information For Patients Is Neededmentioning

confidence: 99%

mentioning

confidence: 99%

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

Way

Bouder

Löfstedt

et al. 2016

Journal of Risk Research

View full text Add to dashboard Cite

show abstract

“…Clinical trial data should be regarded as a public good, 20 and the need for greater transparency in the evidence base behind therapeutic drugs is well documented. 21,22 Several jurisdictions including the US 23 and Europe 24 have established a legal requirement to register clinical trials.…”

Section: Ensure Transparency In Clinical Trialsmentioning

confidence: 99%

Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

Herder

Gibson

Graham

et al. 2014

CMAJ

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“…If the EMA fulfills its promises, a new era of clinical trial data as a public good will begin. 2 Data held by the agency will be available regardless of whether a trial is sponsored by industry, a medical research agency, or a foundation or initiated by investigators.…”

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confidence: 99%

“…2 Currently, the EMA requires applicants to submit clinical study reports for all studies that are carried out (including those that are incomplete or negative) but has not routinely requested that they send the raw data-asking for it and requiring applicants to reanalyze the data only when needed. However, under a separate but related policy that is expected to take effect in 2013, the EMA will request that companies and other sponsors of trials submit the raw data with full details in a format that can be analyzed.…”

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confidence: 99%