Restoring misreported trials of gabapentin for neuropathic pain
We have clinical study reports (CSRs) and individual participant data (IPD) for six trials of gabapentin for neuropathic pain. As described in previous publications, there are multiple data sources for gabapentin trials, which report different study and participant characteristics and different results. Broadly, public sources (e.g., journal articles) tend to overstate the benefits of gabapentin and to underestimate its harms.
As part of the Multiple Data Sources (MUDS) study, we requested additional information about these trials from the manufacturer. In response, Pfizer confirmed that all known materials had already been released during litigation and that no further reports were anticipated.
We plan to submit a proposal to the RIAT support Center to restore these misreported trials, focusing specifically on the misreported harms (“adverse events”). If the proposal is successful, we will develop a statistical analysis plan (SAP) for analyzing and reporting harms, publish a comprehensive summary of all observed harms, and publish a summary of the clinical implications of our findings.
Competing interests:
Data that will be used in this study were extracted for the MUDS study (Kay Dickersin, PI), which was funded by contract ME 1303 5785 from the Patient-Centered Outcomes Research Institute (PCORI) and a fund established at Johns Hopkins for scholarly research on reporting biases by Greene LLP. Evan Mayo-Wilson receives research support from the Laura and John Arnold Foundation
30 August 2019
Evan Mayo-Wilson
Associate Professor
Indiana University School of Public Health-Bloomington
Rapid Response:
Restoring misreported trials of gabapentin for neuropathic pain
We have clinical study reports (CSRs) and individual participant data (IPD) for six trials of gabapentin for neuropathic pain. As described in previous publications, there are multiple data sources for gabapentin trials, which report different study and participant characteristics and different results. Broadly, public sources (e.g., journal articles) tend to overstate the benefits of gabapentin and to underestimate its harms.
As part of the Multiple Data Sources (MUDS) study, we requested additional information about these trials from the manufacturer. In response, Pfizer confirmed that all known materials had already been released during litigation and that no further reports were anticipated.
We plan to submit a proposal to the RIAT support Center to restore these misreported trials, focusing specifically on the misreported harms (“adverse events”). If the proposal is successful, we will develop a statistical analysis plan (SAP) for analyzing and reporting harms, publish a comprehensive summary of all observed harms, and publish a summary of the clinical implications of our findings.
Competing interests: Data that will be used in this study were extracted for the MUDS study (Kay Dickersin, PI), which was funded by contract ME 1303 5785 from the Patient-Centered Outcomes Research Institute (PCORI) and a fund established at Johns Hopkins for scholarly research on reporting biases by Greene LLP. Evan Mayo-Wilson receives research support from the Laura and John Arnold Foundation