Data Withholding in Academic Genetics

Campbell, Eric G.; Clarridge, Brian; Gokhale, Mugdha; Birenbaum, Lauren; Hilgartner, Stephen; Holtzman, Neil A.; Blumenthal, David

doi:10.1001/jama.287.4.473

Cited by 394 publications

(158 citation statements)

References 12 publications

(6 reference statements)

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“…There is also substantial empirical evidence that university researchers are becoming more secretive and less willing to share research results or materials [31][32][33][34][35][36]22]. The causes of this secrecy, however, are still in dispute.…”

Section: Reflecting On the Evidencementioning

confidence: 99%

“…The causes of this secrecy, however, are still in dispute. In particular, we cannot determine the impact of patents themselves on secrecy, in part because many studies of academic secrecy [31,32,36] use composite measures and, as a result, it is difficult to tease out specific causes thereof. Still, Walsh and Hong (2003) [33] and Walsh, Cho and Cohen (2005) [22] find that patents per se have little effect on discussing on-going research or on sharing of research materials.…”

Section: Reflecting On the Evidencementioning

confidence: 99%

“…Still, Walsh and Hong (2003) [33] and Walsh, Cho and Cohen (2005) [22] find that patents per se have little effect on discussing on-going research or on sharing of research materials. In contrast, several studies have found that commercial activity, as well as scientific competition and the cost and effort involved in sharing, all have negative effects on open science [22,31,32,36]. Industry funding is also often associated with delayed publication [31,32,37,38].…”

Section: Reflecting On the Evidencementioning

confidence: 99%

“…In contrast, several studies have found that commercial activity, as well as scientific competition and the cost and effort involved in sharing, all have negative effects on open science [22,31,32,36]. Industry funding is also often associated with delayed publication [31,32,37,38]. This failure to share research materials seems to have a negative impact on research [32,22].…”

Section: Reflecting On the Evidencementioning

confidence: 99%

“…Industry funding is also often associated with delayed publication [31,32,37,38]. This failure to share research materials seems to have a negative impact on research [32,22]. For example, Walsh, et al [22] find that 19% of recent requests were not fulfilled (and that failures to supply materials are increasing), and that at least 8% of respondents had a project delayed due to an inability to get timely access to research materials (compared to 1% who were delayed by an inability to get a patent license).…”

Section: Reflecting On the Evidencementioning

confidence: 99%

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Section: Reflecting On the Evidencementioning

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Section: Reflecting On the Evidencementioning

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Reanalyses of Randomized Clinical Trial Data

Ebrahim

Sohani

Montoya

et al. 2014

JAMA

159

105

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Well-conducted randomized clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of medical therapeutics. Yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results. This limited access does not typically allow others to replicate the trial findings. Given the time and expense required to conduct an RCT, it is often unlikely that others will independently repeat a similar experiment. Thus, the scientific community and the public often accept the results produced and published by the original research team without an opportunity for reanalysis. Increasingly, however, opinions and empirical data are challenging the assumption that the analysis of a clinical trial is straightforward and that analysis by any other group would obtain the same results. [1][2][3] In this issue of JAMA, Ebrahim et al 4 report their findings based on a rigorous search of previously published reanalyses of RCTs. Their first surprising and discomforting finding was just how infrequently data reanalysis has occurred in medical research. Searching the literature from 1966 to present, the authors found only 37 reports that met their criteria as an RCT reanalysis. Of these few reanalyses performed, the majority (84%) had overlapping authors from the original report. Thus, reanalyses are not only rare, but the majority that were reported were not fully independent of the original research group. Despite this overlap, Ebrahim et al report that about half of the reanalyses differed in statistical or analytic approaches, a third differed in the definitions or measurements of outcomes, and most important, a third led to interpretations and conclusions different than those in the original article. While the definition of what constituted different trial analyses, study end points, findings, and interpretations is subjective, the authors' general conclusions were consistent with an emerging literature that indicates RCT reanalysis can yield different results and conclusions from those originally published. Even when the original investigators are presenting evidence in different venues it is not always consistent. For example, there is evidence from trials that data presented to the US Food and Drug Administration (FDA) may differ in important ways from those originally presented at scientific sessions or published in medical journals. Rising et al 5 assessedclinical trial information provided to the FDA and reported a 9% discordance between the conclusions in the report to the FDA and in the published article. Not unexpectedly, all were in the direction favoring the drug.Another example is discordance between what is reported in ClinicalTrials.gov and what is published in journal articles. Hartung et al 2 showed that in a random sample of phase 3 and 4 trials, in 15% the primary end point in the main article was different from the primary end point the trialists reported in ClinicalTrials.gov. Moreover, 22% re...

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