Peter Doshi is an assistant professor of pharmaceutical health services research in the School of Pharmacy and associate editor at The BMJ. His research focuses on policies related to drug safety and effectiveness evaluation in the context of regulation, evidence-based medicine, and debates over access to data. Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise.

Recent Submissions

  • Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology

    Bourgeois, Florence; Hong, Kyungwan; Lee, Haeyoung; Shamseer, Larissa; Spence, O'Mareen; Jefferson, Tom; Doshi, Peter; Jones, Mark A., B.Sc., Ph.D. (BMJ, 2020-03-17)
    Purpose: Trustworthy reporting of quadrivalent human papillomavirus (HPV) vaccine trials is the foundation for assessing the vaccine’s risks and benefits. However, several pivotal trial publications incompletely reported important methodological details and inaccurately described the formulation that the control arms received. Under the Restoring Invisible and Abandoned Trials initiative (RIAT), we aim to restore the public record regarding the content and rationale of the controls used in the trials. Methods: We assembled a cohort (five randomised controlled trials) described as placebo-controlled using clinical study reports (CSRs) obtained from the European Medicines Agency. We extracted the content and rationale for the choice of control used in each trial across six data sources: trial publications, register records, CSR synopses, CSR main bodies, protocols and informed consent forms. Results: Across data sources, the controlwas inconsistently reported as ‘placebo’- containing aluminium adjuvant (sometimes with dose information). Amorphous aluminium hydroxyphosphate sulfate (AAHS) was not mentioned in any trial registry entry, but was mentioned in all publications and CSRs. In three of five trials, consent forms described the control as an ‘inactive’ substance. No rationale for the selection of the control was reported in any trial publication, register, consent form, CSR synopsis or protocol. Three trials reported the rationale for choice of control in CSRs: to preserve blinding and assess the safety of HPV virus-like particles as the ‘safety profile of (AAHS) is well characterised’. Conclusions: The stated rationale of using AAHS control—to characterise the safety of the HPV virus-like particles—lacks clinical relevance. A nonplacebo control may have obscured an accurate assessment of safety and the participant consent process of some trials raises ethical concerns. Trial registration numbers NCT00092482, NCT00092521, NCT00092534, NCT00090220, NCT00090285.
  • Contradictory findings on efficacy of neuraminidase inhibitors not cited

    Doshi, Peter; Jefferson, Tom; Heneghan, Carl; Jones, Mark A., B.Sc., Ph.D. (Oxford University Press (OUP), 2020-04-24)
  • Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.

    Herder, Matthew; Morton, Christopher J.; Doshi, Peter (American Medical Association, 2020-03-02)
  • Statins for primary prevention: what is the regulator’s role?

    Jefferson, Tom; Demasi, Maryanne; Doshi, Peter (BMJ Publishing Group, 2020-02-26)
    Globally, drug regulators have approved statins for the prevention of cardiovascular disease (CVD), although their use in primary prevention has been controversial. A highly publicised debate has ensued over whether the benefits outweigh the harms. Drug regulators, which are legally required to make independent judgements on drug approvals, have remained silent during the debate. Our aim was to navigate the decision-making processes of European drug regulators and ultimately request the data upon which statins were approved. Our findings revealed a system of fragmented regulation in which many countries licensed statins but did not analyse the data themselves. There is no easily accessible archive containing information about the licensing approval of statins or a central location for holding the trial data. This is an unsustainable model and serves neither the general public, nor researchers.
  • Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling.

    Desai, Bansri; Hong, Kyungwan; Powers, John H; Doshi, Peter (Springer Nature, 2019-10-28)
  • Availability of study protocols for randomized trials published in high-impact medical journals: A cross-sectional analysis.

    Spence, O'Mareen; Hong, Kyungwan; Onwuchekwa Uba, Richie; Doshi, Peter (SAGE Publications Inc., 2019-08-26)
    All randomized clinical trials published in Annals of Internal Medicine, BMJ, JAMA, Lancet, and NEJM in 2016 were identified. For each randomized clinical trial, we searched for protocols and statistical analysis plans on journal websites (including supplementary material) and in the article, for example, a referenced publication or link to trial or institutional website. Characteristics of randomized clinical trials were extracted from the publication and clinical trial registry. A detailed assessment of protocols and statistical analysis plans was conducted in a 20% random sample of randomized clinical trials.
  • Correction: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: A protocol [Syst Rev. 4, (2015) (143)] DOI: 10.1186/s13643-015-0134-z.

    Mayo-Wilson, E.; Hutfless, S.; Li, T. (BioMed Central Ltd., 2018)
    Erratum for “Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol for a systematic review” [Syst Rev. 2015] (https://www.doi.org/10.1186/s13643-015-0134-z) The correct title of the article should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". The article is a protocol for a methodological study, not a systematic review. Copyright 2018 The Author(s).
  • When to include clinical study reports and regulatory documents in systematic reviews

    Jefferson, T.; Doshi, P.; Boutron, I. (BMJ Publishing Group, 2018)
    Reporting bias is a major threat to the validity and credibility of systematic reviews. This article outlines the rationale for accessing clinical study reports and other regulatory documents (regulatory data) as a means of addressing reporting bias and identifies factors that may help decide whether (or not) to include regulatory data in systematic reviews. The article also describes the origins and current state of regulatory data access and summarises a survey of current systematic reviewers' practices in considering regulatory data for inclusion in systematic reviews. How to access and extract regulatory data is not addressed. Organisations and other stakeholders such as Cochrane should encourage the use of data from clinical study reports as an important source of data in reviews of pharmaceutical interventions particularly when the intervention in question is of high importance and the risk of reporting bias is great. Copyright Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved.
  • Patient consent to publication and data sharing in industry and NIH-funded clinical trials

    Spence, O.M.; Shin, S.; Doshi, P.; Onwuchekwa Uba, Richie (BioMed Central Ltd., 2018)
    Background: Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. Therefore, non-publication trials-and, more recently, lack of data sharing-are widely considered to violate the trust of trial participants. Existing practices regarding patient consent to publication and data sharing have not been evaluated. Analyzing informed consent forms (ICFs), we studied what trial participants were told regarding investigators' intention to contribute to medical knowledge, publish trial results, and share de-identified trial data. Methods: We obtained 98 ICFs of industry-funded pre-marketing trials for all (17) antibiotics approved by the European Medicines Agency and 46 ICFs of publicly funded trials from the National Heart, Lung and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository. Three authors independently reviewed ICFs to identify and extract what was stated or implied regarding: (1) publication of results; (2) sharing de-identified data; (3) data ownership; (4) confidentiality of identifiable data; and (5) whether the trial will produce knowledge that offers public benefit. Consensus was obtained from the two reviewers with the greatest overall agreement on all five measures. Disagreements were resolved through discussion among all authors. Results: Four (3%) trials indicated a commitment to publish trial results; 140 (97%) did not commit to publishing trial results; six (4%) indicated a commitment to share de-identified data with third party researchers. Commitments to share were more common in publicly funded trials than industry-funded trials (7% vs 3%). A total of 103 (72%) ICFs indicated the trials will or may produce knowledge that offers public benefits, while 131 (91%) ICFs left unstated who "owned" trial data; of those with statements, the sponsor always claimed ownership. Patient confidentiality was guaranteed in 137 (95%) trials. Conclusions: Our results suggest that consent forms rarely disclose investigators' intentions regarding the sharing of de-identified data or publication of trial results. Copyright 2018 The Author(s).
  • The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us?

    Doshi, Peter; Sieluk, Jan; Hung, Anna (American Pharmacists Association, 2019)
    Objectives: To evaluate the degree to which health care professionals and patients receive consistent messages regarding the possible harms of statins. Design: Cross-sectional study of prescribing information (PI), patient package inserts (PPIs), and pharmacy leaflets for 8 statins approved by the U.S. Food and Drug Adminstration. Setting: Not applicable. Participants: Not applicable. Main Outcome Measures: All passages describing 7 adverse events (diarrhea, arthralgia, dyspepsia, confusion, memory loss, rhabdomyolysis, and kidney failure) were extracted from PIs, PPIs, and pharmacy leaflets. For each type of information source and adverse event (drug-harm pair), 2 reviewers independently judged passages as indicating either a confirmed, unconfirmed, or mixed causal relationship between statin and adverse event (drug-harm pair). Disagreements were resolved through consensus, and the consistency between information sources was calculated. Results: PI and PPI consistently conveyed the relationship between a given statin and given adverse event (either both “confirmed” or both “unconfirmed”) in 12 of 17 evaluable drug-harm pairs. PPIs and pharmacy leaflets were consistent in 10 of 10 evaluable drug-harm pairs. PIs indicated a confirmed, causal relationship in 15 drug-harm pairs that were not mentioned in pharmacy leaflets. Likewise, PPIs indicated a confirmed, causal relationship in 7 drug-harm pairs that were not listed in pharmacy leaflets. Conclusion: Despite the widespread use of statins, we discovered considerable ambiguity in language used to describe the evidence concerning their possible harms and variable consistency between PIs, PPIs, and pharmacy leaflets. Further study is needed to understand the reason why pharmacy leaflets did not list, in 15 cases, adverse events that PIs indicated were causally related to the statin.
  • Pandemrix vaccine: why was the public not told of early warning signs?

    Doshi, Peter (BMJ Publishing Group, 2018-09-20)
    Eight years after the pandemic influenza outbreak, a lawsuit alleging that GlaxoSmithKline’s Pandemrix vaccine caused narcolepsy has unearthed internal reports suggesting problems with the vaccine’s safety. Peter Doshi asks what this means for the future of transparency during public health emergencies.
  • The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors

    Hodkinson, Alex; Dietz, Kristina Charlotte; Lefebvre, Carol; Golder, Su; Jones, Mark A., B.Sc., Ph.D.; Doshi, Peter; Heneghan, Carl; Jefferson, Tom; Boutron, Isabelle; Stewart, Lesley (London: BioMed Central, 2018-08-08)
    Background: Clinical study reports (CSRs) are produced for marketing authorisation applications. They often contain considerably more information about, and data from, clinical trials than corresponding journal publications. Use of data from CSRs might help circumvent reporting bias, but many researchers appear to be unaware of their existence or potential value. Our survey aimed to gain insight into the level of familiarity, understanding and use of CSRs, and to raise awareness of their potential within the systematic review community. We also aimed to explore the potential barriers faced when obtaining and using CSRs in systematic reviews. Methods: Online survey of systematic reviewers who (i) had requested or used CSRs, (ii) had considered but not used CSRs and (iii) had not considered using CSRs was conducted. Cochrane reviewers were contacted twice via the Cochrane monthly digest. Non-Cochrane reviewers were reached via journal and other website postings. Results: One hundred sixty respondents answered an open invitation and completed the questionnaire; 20/160 (13%) had previously requested or used CSRs and other regulatory documents, 7/160 (4%) had considered but not used CSRs and 133/160 (83%) had never considered this data source. Survey respondents mainly sought data from the European Medicines Agency (EMA) and/or the Food and Drug Administration (FDA). Motivation for using CSRs stemmed mainly from concerns about reporting bias 11/20 (55%), specifically outcome reporting bias 11/20 (55%) and publication bias 5/20 (25%). The barriers to using CSRs noted by all types of respondents included current limited access to these documents (43 respondents), the time and resources needed to obtain and include these data in evidence syntheses (n = 25) and lack of guidance about how to use these sources in systematic reviews (n = 26). Conclusions: Most respondents (irrespective of whether they had previously used them) agreed that access to CSRs is important, and suggest that further guidance on how to use and include these data would help to promote their use in future systematic reviews. Most respondents who received CSRs considered them to be valuable in their systematic review and/or meta-analysis.
  • Restoring biomedical literature with RIAT

    Doshi, Peter; Shamseer, Larissa; Jones, Mark A., B.Sc., Ph.D.; Jefferson, Tom (BMJ Publishing Group, 2018-04-26)
  • Patient consent to publication and data sharing in industry and NIH-funded clinical trials

    Spence, O’Mareen; Shin, Seongbin; Doshi, Peter; Onwuchekwa Uba, Richie (London: BioMed Central, 2018-05-03)
  • EMA recommendation on hydroxyethyl starch solutions obscured controversy

    Doshi, Peter (BMJ Publishing Group, 2018-03-20)
    As the EMA’s recommendation to suspend HES solutions from the market heads to the European Commission for a final decision, scientists who were asked to provide independent advice say that they were completely ignored

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