Getting It Right: Being Smarter about Clinical Trials

Kramer, Barnett S.; Wilentz, Joan; Alexander, Duane; Burklow, John; Friedman, Lawrence M.; Hodes, Richard J.; Kirschstein, Ruth L.; Patterson, Amy E.; Rodgers, Griffin P.; Straus, Stephen E.

doi:10.1371/journal.pmed.0030144

Cited by 22 publications

(13 citation statements)

References 32 publications

(22 reference statements)

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“…Since there is some indication that the way evidence is presented affects the likelihood of physicians changing their prescribing, 1−5 it is important that CME programs present evidence completely as recommended by the National Institutes of Health. 6 Such a change will require addressing the needs of learners and faculty.…”

Section: Discussionmentioning

confidence: 99%

“…For instance, studies have found that family physicians and specialists consider therapy more effective, and may be more likely to make inappropriate practice changes, when data are presented in relative terms such as relative risk reduction rather than in absolute terms such as absolute risk reduction and number needed to treat (NNT). 1−5 The authors of these papers and the National Institutes of Health 6 suggest that no one measure provides the information necessary for physicians to make an informed decision about results of clinical trials. They suggest that data be presented in absolute and relative terms.…”

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confidence: 99%

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Presentation of evidence in continuing medical education programs: A mixed methods study *

Allen

MacLeod

Handfield-Jones

et al. 2010

Journal of Continuing Education in the Health Professions

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Presentation of evidence in continuing medical education programs: A mixed methods study *

Allen

MacLeod

Handfield-Jones

et al. 2010

Journal of Continuing Education in the Health Professions

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“…Such a threshold could be met by requiring fundamental validity trials. 53 This would strengthen the link between surrogate and true clinical endpoints for commonly employed surrogates such as LDL and hemoglobin A1c levels. Even when established for one drug class (for example, LDL cholesterol and statins), the same surrogate may be a poor choice for a drug class that works through a different mechanism of action (for example, LDL cholesterol and ezetimibe).…”

Section: Policy Recommendationsmentioning

confidence: 86%

Designing Comparative Effectiveness Research On Prescription Drugs: Lessons From The Clinical Trial Literature

2010

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As comparative effectiveness research becomes a more prominent feature of clinical medicine, investigators and policy makers would do well to seek lessons from prior examples of this type of research. Our analysis of previous examples reveals lessons in three key areas: choice of comparison treatments, time frame of study, and widespread applicability of study results. Based on our observations, we offer suggestions for increasing the clinical applicability of comparative effectiveness research, such as employing surrogate endpoints that meet a specific threshold of validity. Future trials that address these areas of concern hold the greatest promise for improving patients' outcomes.

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“…Statisticians’ roles in the design, analysis and reporting of pharmaceutical research spans the whole range of clinical studies from phase 1, including first‐in‐man studies, to major prelicensing phase 3 trials for regulatory approval, as well as preclinical animal studies and post‐licensing pharmacoepidemiology and pharmacovigilance. Drug safety issues can emerge preclinically, or only post licensing (Kramer et al. , 2006) when their emergence may call into question past regulatory decisions (Dhaun et al.…”

Section: Introduction: History and Remitmentioning

confidence: 99%

“…Statisticians in the pharmaceutical industry, and in regulatory authorities (Cochrane Collaboration, 2006; Food and Drug Administration, 2006; Ioannidis et al. , 2004; Kramer et al. , 2006; O'Neill, 2002), thus have a key role in enhancing the scientific and ethical quality of all these phases of pharmaceutical research.…”

Section: Introduction: History and Remitmentioning

confidence: 99%

Statistical Issues in First-In-Man Studies

Senn

Amin

Bailey

et al. 2007

Journal of the Royal Statistical Society Series A: Statistics in Society

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In March 2006 a first-in-man trial took place using healthy volunteers involving the use of monoclonal antibodies. Within hours the subjects had suffered such adverse effects that they were admitted to intensive care at Northwick Park Hospital. In April 2006 the Secretary of State for Health announced the appointment of Professor (now Sir) Gordon Duff, who chairs the UK's Commission on Human Medicines, to chair a scientific expert group on phase 1 clinical trials. The group reported on December 7th, 2006 (Expert Scientific Group on Clinical Trials, 2006a). Clinical trials have a well-established regulatory basis both in the UK and worldwide. Trials have to be approved by the regulatory authority and are subject to a detailed protocol concerning, among other things, the study design and statistical analyses that will form the basis of the evaluation. In fact, a cornerstone of the regulatory framework is the statistical theory and methods that underpin clinical trials. As a result, the Royal Statistical Society established an expert group of its own to look in detail at the statistical issues that might be relevant to first-in-man studies. The group mainly comprised senior Fellows of the Society who had expert knowledge of the theory and application of statistics in clinical trials. However, the group also included an expert immunologist and clinicians to ensure that the interface between statistics and clinical disciplines was not overlooked. In addition, expert representation was sought from Statisticians in the Pharmaceutical Industry (PSI), an organization with which the Royal Statistical Society has very close links. The output from the Society's expert group is contained in this report. It makes a number of recommendations directed towards the statistical aspects of clinical trials. As such it complements the report by Professor Duff's group and will, I trust, contribute to a safer framework for first-in-man trials in the future. Tim Holt ("President, Royal Statistical Society") Copyright 2007 Royal Statistical Society.

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Getting It Right: Being Smarter about Clinical Trials

Abstract: A major NIH meeting led to recommendations for conducting better clinical trials.

Cited by 22 publications

References 32 publications

Presentation of evidence in continuing medical education programs: A mixed methods study *

Presentation of evidence in continuing medical education programs: A mixed methods study *

Designing Comparative Effectiveness Research On Prescription Drugs: Lessons From The Clinical Trial Literature

Statistical Issues in First-In-Man Studies

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