Data Sharing Statements for Clinical Trials — A Requirement of the International Committee of Medical Journal Editors

Taichman, Darren B.; Sahni, Peush; Pinborg, Anja; Peiperl, Larry; Lainé, Christine; James, Astrid; Hong, Sung-Tae; Haileamlak, Abraham; Gollogly, Laragh; Godlee, Fiona; Frizelle, Frank; Florenzano, Fernando; Drazen, Jeffrey M.; Bauchner, Howard; Baethge, Christopher; Backus, Joyce

doi:10.1056/nejme1705439

Cited by 138 publications

(91 citation statements)

References 2 publications

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“…The inability of bococizumab to provide effective and durable lowering of LDL‐C levels to reduce the risk of future cardiovascular events was a major factor in the decision to discontinue the global clinical development program for bococizumab . Despite this setback, Pfizer strongly believes there is an ethical obligation to publish results from the bococizumab clinical trial program—not only to honor the altruism shown by trial participants who put themselves at risk by enrolling in these trials but also to maximize the clinical and scientific knowledge derived from the halted trials—and supports initiatives by the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) on public disclosure of trial results and sharing of trial data …”

Section: Discussionmentioning

confidence: 99%

The effects of single‐ and multiple‐dose administration of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, in hypercholesterolemic subjects treated with and without atorvastatin: Results from four phase I studies

Gumbiner

Joh

Hong

et al. 2017

Cardiovascular Therapeutics

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Summary Aims Three single‐dose and one multiple‐dose phase I studies were conducted in subjects with primary hypercholesterolemia to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bococizumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. Methods The dosing schedules for hypercholesterolemic subjects randomized in the four phase I studies were (1) ascending, single, intravenous (IV) bococizumab (0.3, 1, 3, 6, 12, or 18 mg/kg), or placebo (N = 48; baseline low‐density lipoprotein cholesterol [LDL‐C] ≥130 mg/dL); (2) single, IV bococizumab (0.5 or 4 mg/kg; no placebo) added to ongoing atorvastatin 40 mg/day (N = 24); (3) single, fixed, subcutaneous (SC) bococizumab (100 or 200 mg), or IV bococizumab (200 mg; no placebo; N = 49; baseline LDL‐C ≥130 mg/dL); and (4) weekly IV bococizumab (0.25, 0.5, 1, or 1.5 mg/kg) or placebo for 4 weeks (N = 67; baseline LDL‐C ≥130 mg/dL). Results Bococizumab pharmacokinetics were well characterized following single IV or SC doses and following multiple IV doses. Exposure to single‐dose bococizumab increased slightly greater than dose‐proportionally and clearance decreased with increasing dose. In the single‐dose studies, maximal mean percent reductions from baseline in LDL‐C ranged from 43% (0.3 mg/kg) to 84% (18 mg/kg) in bococizumab‐treated subjects, compared with 2% for placebo. For the multiple‐dose study, maximal reductions in LDL‐C ranged from 55% (0.25 mg/kg) to 66% (1 mg/kg) in bococizumab‐treated subjects, compared with 9% for placebo. In all studies, adverse events were infrequent, transient, and not dose‐related. Conclusions Bococizumab was generally safe and well tolerated. Bococizumab lowered LDL‐C levels substantially in all four studies.

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Section: Discussionmentioning

confidence: 99%

The effects of single‐ and multiple‐dose administration of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, in hypercholesterolemic subjects treated with and without atorvastatin: Results from four phase I studies

Gumbiner

Joh

Hong

et al. 2017

Cardiovascular Therapeutics

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“…1–4 The European Medicines Agency has implemented a policy to expand public access to data concerning products it approves, 5,6 the Food and Drug Administration is considering how to expand access to data pooled within a product class, 7 major research sponsors 8–12 and journal editors 13 have begun promoting data sharing, and lawmakers’ interest 14 has resulted in legislation authorizing the National Institutes of Health to require all of its grantees to share data. 15,16 Pharmaceutical industry associations have committed to making data more accessible, 17 and several data platforms are now available.…”

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confidence: 99%

“…4,26 In addition, data sharing helps fulfill the ethical obligation to make the most of research participants’ contributions to science. 13,27–30 …”

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confidence: 99%

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

2018

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BACKGROUND Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants’ perceptions of the risks of data sharing. METHODS We conducted a structured survey of 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. Surveys were distributed by mail (350 completed surveys) and in clinic waiting rooms (421 completed surveys) (overall response rate, 79%). RESULTS Less than 8% of respondents felt that the potential negative consequences of data sharing outweighed the benefits. A total of 93% were very or somewhat likely to allow their own data to be shared with university scientists, and 82% were very or somewhat likely to share with scientists in for-profit companies. Willingness to share data did not vary appreciably with the purpose for which the data would be used, with the exception that fewer participants were willing to share their data for use in litigation. The respondents’ greatest concerns were that data sharing might make others less willing to enroll in clinical trials (37% very or somewhat concerned), that data would be used for marketing purposes (34%), or that data could be stolen (30%). Less concern was expressed about discrimination (22%) and exploitation of data for profit (20%). CONCLUSIONS In our study, few clinical trial participants had strong concerns about the risks of data sharing. Provided that adequate security safeguards were in place, most participants were willing to share their data for a wide range of uses. (Funded by the Greenwall Foundation.)

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“…Finally, a more open access to clinical data is warranted, allowing investigators to perform independent analysis and reporting of data in this field. In this regard, we applaud the recent editorial initiative launched by the International Committee of Medical Journals Editors (ICMJE) on data sharing …”

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confidence: 99%

The hypothesis of an increased mortality following paclitaxel coated device use in peripheral vascular interventions (and the emerging era of meta‐analysis based evidence)

Cortese

Alfonso

Pellegrini

et al. 2019

Cathet Cardio Intervent

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The hypothesis of an increased mortality following paclitaxel coated device use in peripheral vascular interventions (and the emerging era of meta-analysis based evidence) Over the last several months, a tsunami of information covered the headlines of all medical media shaking the world of vascular specialists. The controversy, based on the publication of a single meta-analysis 1 showing an increase in long-term mortality following the use of paclitaxel-coated devices (including both drug-coated balloons [DCB] and drug-eluting stents [DES]) for the treatment of femoropopliteal disease continues to challenge the academic, clinical, and regulatory world.The authors reported a similar mortality rate between both the treatment and control groups at 1-year (2.3%), but a higher mortality at 2 (7.3 vs. 3.8% for paclitaxel-eluting devices vs. uncoated balloons,

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Data Sharing Statements for Clinical Trials — A Requirement of the International Committee of Medical Journal Editors

Cited by 138 publications

References 2 publications

The effects of single‐ and multiple‐dose administration of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, in hypercholesterolemic subjects treated with and without atorvastatin: Results from four phase I studies

The effects of single‐ and multiple‐dose administration of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, in hypercholesterolemic subjects treated with and without atorvastatin: Results from four phase I studies

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

The hypothesis of an increased mortality following paclitaxel coated device use in peripheral vascular interventions (and the emerging era of meta‐analysis based evidence)

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