• Covid-19: Should doctors recommend treatments and vaccines when full data are not publicly available?

      Johnson, Raymond M.; Doshi, Peter; Healy, David, 1954- (BMJ, 24/08/2020)
    • Determining the infectious potential of individuals with positive RT-PCR SARS-CoV-2 tests

      Doshi, Peter; Powers, John H (Oxford University Press, 2020-12-04)
    • Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19

      Edmonds, Sterling; MacGregor, Andrea; Doll, Agnieszka; Vural, Ipek Eren; Graham, Janice; Fierlbeck, Katherine; Lexchin, Joel; Doshi, Peter; Herder, Matthew (Oxford University Press, 2020-11-19)
    • Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial

      Bourgeois, Florence; Doshi, Peter; Hong, Kyungwan; Jefferson, Tom; Jones, Mark; Lee, Haeyoung; Rowhani-Farid, Anisa; Shamseer, Larissa; Spence, O'Mareen (American Society for Microbiology, 2020-11-04)
    • Covid-19 vaccine trial protocols released

      Doshi, Peter (BMJ Publishing Group, 2020-10-21)
    • Covid-19: Do many people have pre-existing immunity?

      Doshi, Peter (BMJ Publishing Group, 2020-09-17)
    • Integrated Drug Reviews at the US Food and Drug Administration-Reply

      Doshi, Peter; Morton, Christopher J.; Herder, Matthew (American Medical Association, 2020-07-27)
    • 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)
    • Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology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.
    • 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.
    • 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.
    • 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)
    • Restoring biomedical literature with RIAT

      Doshi, Peter; Shamseer, Larissa; Jones, Mark A., B.Sc., Ph.D.; Jefferson, Tom (BMJ Publishing Group, 2018-04-26)
    • 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
    • FDA to begin releasing clinical study reports in pilot programme

      Doshi, Peter (BMJ Publishing Group, 2018-01-23)
    • Noninferiority Trials [letter to the editor]

      Doshi, Peter (Boston : Massachusetts Medical Society, 2018-01-18)
    • 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).
    • 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).
    • Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy

      Doshi, Peter (Elsevier, 2017-08-22)
      Objective: To determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs). Study Design and Setting: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and non-public sources (clinical study reports [CSRs] and individual participant data [IPD]). Results: We found 21 gabapentin RCTs (74 reports, six IPD) and seven quetiapine RCTs (50 reports, one IPD); most were reported in journal articles (18/21 [86%] and 6/7 [86%], respectively). When available, CSRs contained the most trial design and risk of bias information. CSRs and IPD contained the most results. For the outcome domains “pain intensity” (gabapentin) and “depression” (quetiapine), we found single trials with 68 and 98 different meta-analyzable results, respectively; by purposefully selecting one meta-analyzable result for each RCT, we could change the overall result for pain intensity from effective (standardized mean difference [SMD]=-0.45; 95%CI -0.63 to -0.27) to ineffective (SMD=-0.06; 95%CI -0.24 to 0.12). We could change the effect for depression from a medium effect (SMD=-0.55; 95%CI -0.85 to -0.25) to a small effect (SMD=-0.26; 95%CI -0.41 to -0.1). Conclusions: Disagreements across data sources affect the effect size, statistical significance, and interpretation of trials and meta-analyses.
    • Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

      Doshi, Peter (American Medical Association, 2017-08-21)
      IMPORTANCE: Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. OBJECTIVE: To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. DESIGN AND SETTING: Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. MAIN OUTCOMES AND MEASURES: Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. RESULTS: We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. CONCLUSIONS AND RELEVANCE: Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.
    • The wider role of regulatory scientists

      Doshi, Peter; Godlee, Fiona (BMJ Publishing Group, 2017-04-27)
    • FDA unease about faster drug approval

      Doshi, Peter (BMJ Publishing Group, 2017-04-06)
    • Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

      Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich (BMJ Publishing Group, 2017-02-07)
      Objectives: To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design: Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting: Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures: Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results: Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions: Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians’ reporting behaviours of adverse drug reactions.
    • Convicting Zika

      Doshi, Peter (BMJ Publishing Group, 2016-04-07)
    • North American regulatory agencies can and should make clinical trial data publicly available

      Persaud, Nav; Doshi, Peter (Canadian Medical Association, 2016-02-02)
    • Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data

      Heneghan, Carl; Onakpoya, Igho; Jones, Mark A., B.Sc., Ph.D.; Doshi, Peter; Del Mar, Chris; Hama, Rokuro, M.D.; Thompson, Matthew J.; Spencer, Elizabeth A.; Mahtani, Kamal R.; Nunan, David, M.Sc., Ph.D.; et al. (NIHR Journals Library, 2016)
      Objectives: To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design: Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting: Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures: Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results: Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions: Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians’ reporting behaviours of adverse drug reactions.
    • Visualising childhood vaccination schedules across G8 countries

      Doshi, Peter; Stahl-Timmins, Will; Merino-Juarez, Jose G.; Simpkins, Carolyn (BMJ Publishing Group, 2015-11-16)
    • Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol for a systematic review

      Mayo-Wilson, Evan; Hutfless, Susan; Li, Tianjing, Ph.D.; Gresham, Gillian; Fusco, Nicole; Ehmsen, Jeffrey; Heyward, James; Vedula, S. Swaroop; Lock, Diana; Haythornthwaite, Jennifer A., Ph.D.; et al. (Systematic Reviews, 2015-11-02)
    • Are manufacturers sharing data as promised?

      Doshi, Peter; Mayo-Wilson, Evan; Dickersin, Kay (BMJ Publishing Group, 2015-09-25)
    • 21st century cures: is US medicines bill a colossal mistake?

      Doshi, Peter (BMJ Publishing Group, 2015-07-23)
    • FDA drug summaries: a simplification too far?

      Doshi, Peter (BMJ Publishing Group, 2015-06-12)
    • The evidence base for new drugs

      Doshi, Peter; Jefferson, Tom (BMJ Publishing Group, 2015-03-02)
    • Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports

      Jefferson, Tom; Jones, Mark A., B.Sc., Ph.D.; Doshi, Peter; Del Mar, Chris; Hama, Rokuro, M.D.; Thompson, Matthew J.; Onakpoya, Igho; Heneghan, Carl (BMJ Publishing Group, 2014-09)
    • US incentive scheme for neglected diseases: a good idea gone wrong?

      Doshi, Peter (BMJ Publishing Group, 2014-07-21)
    • Authors' reply to Dunning

      Doshi, Peter; Jefferson, Tom (BMJ Publishing Group, 2014-04-30)
    • Multisystem failure: the story of anti-influenza drugs

      Doshi, Peter; Jefferson, Tom (BMJ Publishing Group, 2014-04-10)
    • Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments

      Jefferson, Tom; Jones, Mark A., B.Sc., Ph.D.; Doshi, Peter; Spencer, Elizabeth A.; Onakpoya, Igho; Heneghan, Carl (BMJ Publishing Group, 2014-04-09)
    • Speeding new antibiotics to market: a fake fix?

      Doshi, Peter (BMJ Publishing Group, 2014-03-25)
    • Clinical trial data: get them while you can

      Doshi, Peter; Groves, Trish; Loder, Elizabeth (BMJ Publishing Group, 2014-01-06)
    • Putting GlaxoSmithKline to the test over paroxetine

      Doshi, Peter (BMJ Publishing Group, 2013-11-12)
    • YODA and truth seeking in medicine

      Doshi, Peter; Vedula, S. Swaroop; Li, Tianjing, Ph.D. (BMJ Publishing Group, 2013-07-02)
    • Restoring invisible and abandoned trials: a call for people to publish the findings

      Doshi, Peter; Dickersin, Kay; Vedula, S. Swaroop; Jefferson, Tom; Healy, David, 1954- (BMJ Publishing Group, 2013-06-13)
    • Influenza: marketing vaccine by marketing disease

      Doshi, Peter (BMJ Publishing Group, 2013-05-16)
    • Influenza vaccination of health care workers

      Doshi, Peter; Abi-Jaoude, Elia; Lexchin, Joel; Jefferson, Tom; Thomas, Roger E., M.D., Ph.D. (Canadian Medical Association, 2013-02-05)
    • The imperative to share clinical study reports: recommendations from the Tamiflu experience

      Doshi, Peter; Jefferson, Tom; Del Mar, Chris (Public Library of Science, 2012-04-10)
      Summary points: - Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data. - More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators. - Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers. - We propose clinical study reports become available to such scrutiny, and describe one manufacturer's unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.
    • Rethinking credible evidence synthesis

      Doshi, Peter; Jones, Mark A., B.Sc., Ph.D.; Jefferson, Tom (BMJ Publishing Group, 2012-01-17)
    • Does oseltamivir really reduce complications of influenza?

      Cochrane Neuraminidase Inhibitors Review Team; Del Mar, Chris; Doshi, Peter; Hama, Rokuro, M.D.; Heneghan, Carl; Jefferson, Tom; Jones, Mark A., B.Sc., Ph.D.; Thompson, Matthew J. (University of Chicago Press, 2011-12-15)
    • Ensuring safe and effective drugs: who can do what it takes?

      Jefferson, Tom; Doshi, Peter; Thompson, Matthew J.; Heneghan, Carl (BMJ Publishing Group, 2011-01-11)
    • Another question for GSK

      Doshi, Peter; Jefferson, Tom (BMJ Publishing Group, 2010-06-29)
    • Neuraminidase inhibitors--the story behind the Cochrane review

      Doshi, Peter (BMJ Publishing Group, 2009-12-08)
    • Calibrated response to emerging infections

      Doshi, Peter (BMJ Publishing Group, 2009-09-03)
    • Popular and scientific attitudes regarding pandemic influenza

      Doshi, Peter (Centers for Disease Control and Prevention (CDC), 2008-09-14)
    • The elusive definition of pandemic influenza

      Doshi, Peter (World Health Organization, 2008-07-01)
      There has been considerable controversy over the past year, particularly in Europe, over whether the World Health Organization (WHO) changed its definition of pandemic influenza in 2009, after novel H1N1 influenza was identified. Some have argued that not only was the definition changed, but that it was done to pave the way for declaring a pandemic. Others claim that the definition was never changed and that this allegation is completely unfounded. Such polarized views have hampered our ability to draw important conclusions. This impasse, combined with concerns over potential conflicts of interest and doubts about the proportionality of the response to the H1N1 influenza outbreak, has undermined the public trust in health officials and our collective capacity to effectively respond to future disease threats. WHO did not change its definition of pandemic influenza for the simple reason that it has never formally defined pandemic influenza. While WHO has put forth many descriptions of pandemic influenza, it has never established a formal definition and the criteria for declaring a pandemic caused by the H1N1 virus derived from "pandemic phase" definitions, not from a definition of "pandemic influenza". The fact that despite ten years of pandemic preparedness activities no formal definition of pandemic influenza has been formulated reveals important underlying assumptions about the nature of this infectious disease. In particular, the limitations of "virus-centric" approaches merit further attention and should inform ongoing efforts to "learn lessons" that will guide the response to future outbreaks of novel infectious diseases.
    • Trends in recorded influenza mortality: United States, 1900-2004

      Doshi, Peter (American Public Health Association, 2008-05)
      OBJECTIVES: I sought to describe trends in historical influenza mortality data in the United States since 1900 and compare pandemic with nonpandemic influenza seasons. -- METHODS: I compiled a database of monthly influenza-classed death rates from official US mortality tables for the years 1900 to 2004 (1905-1909 excluded), from which I calculated adjusted influenza season (July 1-June 30) mortality rates. -- RESULTS: An overall and substantial decline in influenza-classed mortality was observed during the 20th century, from an average seasonal rate of 10.2 deaths per 100 000 population in the 1940s to 0.44 per 100 000 by the 1990s [corrected] . The 1918-1919 pandemic stands out as an exceptional outlier. The 1957-1958 and 1968-1969 influenza pandemic seasons, by contrast, displayed substantial overlap in both degree of mortality and timing compared with nonpandemic seasons. -- CONCLUSIONS: The considerable similarity in mortality seen in pandemic and non-pandemic influenza seasons challenges common beliefs about the severity of pandemic influenza. The historical decline in influenza-classed mortality rates suggests that public health and ecological factors may play a role in influenza mortality risk. Nevertheless, the actual number of influenza-attributable deaths remains in doubt.
    • Preventing flu-like illness: Reason for optimism

      Doshi, Peter (BMJ Publishing Group, 2008-01-24)
    • Influenza vaccination: policy versus evidence

      Doshi, Peter (BMJ Publishing Group, 2006-11)
    • Are US flu death figures more PR than science?

      Doshi, Peter (BMJ Publishing Group, 2005-12-10)
    • Antibiotics Approved for Marketing in Populations Specifically Excluded From Premarketing Trials, 1999-2018

      Kuzucan, Aida; Powers, John H; Doshi, Peter
      Approval by the US Food and Drug Administration (FDA) of a drug for a given indication is thought to reassure clinicians, other health care providers, and patients that substantial evidence of effectiveness exists for specific indicated populations (patients and diseases). This study examines whether FDA approval of certain antibiotics should be so reassuring for all patient populations identified in the FDA-approved labels. Specifically, this study compared patient populations covered by FDA-approved labels for 21 novel antibiotics approved between 1999 and 2018 to the patient exclusion and inclusion criteria of pivotal trials that supported those approvals. We found that every FDA-approved label for these antibiotics included at least one identifiable patient population that was explicitly excluded from enrolling in the supporting pivotal trials. Two antibiotics, bedaquiline and ceftazidime-avibactam, were approved for use in populations that were fully excluded from enrolling in registration trials.