If a clinical research trial showed that an oncology drug you were prescribing to your patients had a previously unrecognized adverse side effect, how soon would you want to know? Would you prefer to know as soon as the data was available—or 300 days later?
Oncologists and other members of the cancer care team would presumably want that information sooner rather than later to be able to more appropriately prescribe those drugs and take care of their patients. But new data that reviewed 100 pharmaceutical company-sponsored clinical trials shows that the median delay from when results are available to publication of complete data was 300 days, with negative findings taking longer to reach the public. The study was recently published online in JAMA Oncology (2018; doi:10.1001/jamaoncol.2018.0264).
“The complete and timely dissemination of clinical trial data is essential to all fields of medicine, with delayed or incomplete data release having potentially deleterious effects on both patient care and scientific inquiry,” the researchers noted in the study. “Even for the most pressing study findings, median publication delays approach 1 year.”
The median delay for trials reporting negative trial data was 407 days.
Though previous studies have investigated delays in the publication of clinical trial data, this new study used novel criteria for selecting trials for the analysis. The researchers only looked at phase III industry-sponsored trials for which the drug company had issued a press release about the results.
“Industry-sponsored phase III trials examining novel therapeutics have some of the greatest potential to shape practice guidelines and research programs in oncology,” explained study coauthor Lindor Qunaj, BSc, a medical student at the Warren Alpert Medical School of Brown University. “These studies also offer a clear proxy—in the form of a press release—for the time at which data is sufficiently processed to draw a directional conclusion.”
The study measured the duration from when a press release announcing trial findings was issued until that data were posted on ClinicalTrials.gov or published in a medical journal.
The eight drug companies from which sponsorship of the clinical trials analyzed in this study come collectively accounted for 72 percent of all oncology drug sales in 2015, according to the study.
In an interview with Oncology Times, here's why Qunaj says these findings are so important.
1 What were the key findings from this new research and why are they so important now?
“Even for clinical trials expected to have an important effect on patient care and scientific innovation in the field of oncology, delays in meaningful data release are considerable. These delays are significantly longer for studies reporting negative (compared to positive) results.
“Delayed or incomplete release of clinical trial results forces providers to make treatment decisions based on limited information, potentially putting patients at risk of newly discovered toxicities—or not offering interventions that may prolong survival.
“It also causes companies and researchers to shape their research agendas with incomplete data, which can lead to duplicative studies and slow the overall pace of medical innovation. Our study sought to better characterize the magnitude of these delays.”
2 Given the delays in the publication of clinical trial results that you've identified, what's the next step in moving the needle to actually improve the situation?
“Our research suggests the scientific community has a long way to go in improving the speed and completeness of clinical trial data releases. We recommend 1) placing a greater emphasis on prepublication, and 2) more strictly enforcing data posting requirements on databases, such as ClinicalTrials.gov, as two potential approaches for change. But we recognize that these suggestions are just a start.
“Any strategy designed to facilitate rapid and thorough data dissemination will need to secure buy-in from journals, regulatory agencies, conference organizers, and industry sponsors to be broadly effective. Because these varied stakeholders often have competing interests, creating integrated solutions may be difficult, but should be a priority—not just in oncology—but across the biomedical community. In the meantime, both patients and the pace of scientific innovation will continue to be negatively affected.”
3 Do you plan to do any follow-up investigation in this area?
“A natural follow-up from our study would be to estimate the effect data delays have on patient outcomes. How many patients are being treated with incomplete information each day, and how would their management have differed if that information were available? While these calculations would be decidedly difficult to perform, the conclusions could serve as even more convincing arguments for systemic policy change.”