New England Journal of Medicine. 2016; 375:405-407.
… A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data. The original investigators almost always intend to undertake additional analyses of the data and explore new hypotheses. Moreover, large, multicenter trials with large numbers of investigators often require several articles to fully describe the results. These investigators are partly motivated by opportunities to lead these secondary publications. We believe 6 months is insufficient for performing the extensive analyses needed to adequately comprehend the data and publish even a few articles. Once the investigators who have conducted the trial no longer have exclusive access to the data, they will effectively be competing with people who have not contributed to the substantial efforts and often years of work required to conduct the trial.… In summary, we recommend that the ICMJE come together with trialists and other stakeholders to discuss the potential benefits, risks, burdens, and opportunity costs of its proposal and explore alternatives that will achieve the same goals efficiently. Moreover, we recommend modifying the proposal as follows. First, the timeline for providing deidentified individual patient data should allow a minimum of 2 years after the first publication of the results and an additional 6 months for every year required to complete the study, up to a maximum of 5 years. Second, to enhance readers’ confidence in published data, an independent statistician should have the opportunity to conduct confirmatory analyses before publication of an article, thereby advancing the ICMJE’s stated goal of increasing “confidence and trust in the conclusions drawn from clinical trials.” Finally, persons who were not involved in an investigator-initiated trial but want access to the data should financially compensate the original investigators for their efforts and investments in the trial and the costs of making the data available.
Medical Researchers Want Up To Five Years Exclusivity For Clinical Trial Data Derived From Volunteerstechdirtby Glyn MoodyAugust 8, 2016
While the standard for approval is low, FDA approval isn’t intended to direct clinicians. It simply means that the drug has demonstrated medicinal properties and is deemed safe for human use. The malignant problem has arisen from the version of those trials that has made it into the medical literature, regularly inflating efficacy, downplaying toxicity, and laying a base for advertising campaigns that opportunize on our patien’ts desire for symptom relief and/or wellness. The aura of FDA approval and publication in the scientific literature has been parlayed into billions of dollars in ill-gotten profits. Worse, it has catapulted medication induced mortality and morbidity into the majors.
Clinical Trials are referred to as "research" and the people in charge of these studies call themselves "researchers." Research is exploration in search of new findings. These clinical Trials aren’t research, they’re product testing – governed by strict rules to be validating. And so many of the published results make a mockery of these basic rules: Randomization, Double Blinding, Preregistration of Outcomes followed by Replication of positive results. The NEJM article describes a mythical process bearing little resemblance to what actually happens in these largely commercially conducted trials. The analysis could, and perhaps should, be done the day the trial ends and the blind is broken. If they want to play around with the data for some kind of exploratory research, they could simply hold on to the original protocol directed analysis until their other data play is finished. Truth-be-told, this plea for time to play around with the data is an admission of guilt – Hypotheses After Results Known!