The topic of clinical data disclosure has been brewing up so much controversy lately that it has now become impossible for the media to ignore it any longer. On one hand, you have industry thought leaders like Dr. Peter Doshi and Dr. Ben Goldcare who have spoken up countless times on how pharma has an ethical obligation to fully disclose clinical trial data to the public because it promotes better-informed decisions about patient treatment. Their opinions surrounding this issue have certainly ignited questions about what factors are influencing organizations to default to limited transparency and what clinical trial data reporting and publishing guidelines should be implemented.
And on the other side of the spectrum, certain pharmaceutical organizations and associations, including PhRMA and EFPIA, are fighting for limited disclosure arguing the imperativeness of protecting proprietary information in order to drive innovation and maintain the competitive edge.
Who's Speaking Up in Support?
Dr. Doshi and Dr. Goldacre have been two of the loudest voices calling for full data disclosure of clinical trials. Doshi, a scientist of comparative effectiveness research at Johns Hopkins and associate editor at BMJ, believes that “there are strong ethical arguments for ensuring that all clinical study reports are publicly accessible.” According to Doshi, it all boils down to the financial interests that are often suffused within R&D as well as publication bias by medical journals that can sway how clinical trial data is reported. Companies spend millions in R&D to prove the effectiveness and efficacy of their drugs and therapies. When clinical trial results do not support this claim, Doshi believes that pharma needs to be more transparent since clinical trials are “experiments conducted on humans” and non-disclosure of complete trial results “undermine the philanthropy of human participants and sets back pursuit of knowledge.”
When only approximately half of all clinical trials are published and a majority of trials with negative results are most often pushed under the rug, Goldacre, founder of the AllTrials Campaign, calls for all trials to be registered and have their results, even if they are not advantageous, publicly reported and published. Like Doshi, Goldacre suggests that the current status quo of reporting clinical trial results is unsatisfactory and has the potential to harm patient care as much as medical incompetence.
The AllTrials Campaign
The AllTrails Campaign "calls for all past and present clinical trials to be registered and their results reported." The campaign is based on The Declaration of Helsinski- The WorldMedical Association's standards for "medical research involving people." Essentially, this campaign is based on four tiers of clinical trial reporting
The Four Tiers
Suggests that all planned clinical trials be registered with a statement of the trial procedure and protocol before the recruitment process begins. In addition, all past clinical trials that have not been registered will be required to do so. In order to enforce this rule, AllTrails Campaign requests that funding is frozen for the clinical trial until details of the trial and the trial itself is registered.
2. SUMMARY RESULTS REPORTING
According to the AllTrials website:
A summary of results should be publicly available where the trial was registered, within one year of completion of the trial. Summary results from all past trials of medicines currently in use should be made publicly available on a register now. Summary results include information on the primary and any secondary outcomes measured and statistical analysis. This is part of the structured information that global registries should support.
AllTrials calls for an expansion of reporting oversight and calls for countries to have more consistent open public audits for each trial. Funders could be stricter in withholding funds until trial results are made public.
3. PUBLISHED FULL OUTCOMES REPORT
In order to make the best informed decisions, AllTrials states that full reports after the completion of clinical trial should be published. "Full reports sometimes contain narrative descriptions of adverse events experienced by trial participants. This information is important to understanding the trade-off between risks and benefits of treatment."
4. INDIVIDUAL PATIENT DATA
The AllTrials Campaign is calling for the first three types of disclosure to be required. The fourth, individual patient data, would offer significant opportunities for research, including improving the accuracy estimates of treatment benefits and identifying subgroups of patients who would respond better (or worse) to a specific treatment. However, releasing patient-level data would cross a fine line between better science (according to some) and protecting patient privacy.
And what are others saying?
On the other side of the argument are pharmaceutical industry trade groups, such as PhRMA and EFPIA. In a February statement, PhRMA argued that the demands by Dr. Goldacre to release patient-level clinical data are “irresponsible with potentially harmful consequences for future medicine development” because the recommendations would jeopardize patient privacy and could dissuade individuals from clinical trial participation. Additionally, it would encourage second-guessing the regulatory approval process.
EFPIA Director General, Richard Bergström, says that the association is worried by a move towards greater clinical trial data transparency because it seems as though the advocates of increasing transparency are putting disclosure ahead of public health interests. He argues that the EMA proposals for full data disclosure will “undermine the trust in the regulatory approval system governing biopharmaceutical products and introduce risks of misinterpretation and misuse of clinical data into the process.”
In July, PhRMA and EFPIA released joint “Principles for Responsible Clinical Trial Data Sharing,” which they hope will set the standard for the entire pharmaceutical industry’s data sharing policies. Under the joint Principles, synopses of clinical-study reports filed with the US Food and Drug Administration, the EMA or national authorities in EU member states will be made publicly available when a new medicine or indication is approved.
Potentially valid reasons for restricting the full public release of clinical study reports include:
- Ensuring patient confidentiality
- Commercial secrets
- Industry concerns over adversaries' malicious “cherry picking” over large datasets
So, what side of the argument do you fall on? Should full disclosure of clinical trial data be released, as advocated by Dr.’s Doshi and Goldacre, or should data transparency be approached more cautiously, as recommended by PhRMA and EFPIA?
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