Lack of Tranparency in Trials for Cancer Medication: Study

Oncologist showing CT image to cancer patient during chemotherapy. By Framestock/Adobe Stock

A multi-national study led by Australia’s Flinders University has found that more than 50 percent of the clinical trials the U.S. Food and Drugs Administration (FDA) used to approve anti-cancer medications over the past decade are not available for public scrutiny.

This comes after the pharmaceutical industry made a commitment in 2014 to improve data transparency.

Authors of the study say that commitment needs revisiting as it was supposed to be about restoring confidence in evidence-based medicine and allowing data to be used for further research into medicine safety and efficacy.

The team looked at what proportion of clinical trials that led to the registration of anti-cancer drugs were eligible for sharing with qualified researchers, revealing that of the 304 trials which underpinned the registration of 115 anti-cancer medications over the past ten years, only 136 had individual patient data available.

Senior author of the study and leader of the Clinical Cancer Epidemiology Lab at Flinders, Dr. Ash Hopkins, said in a university release on Monday that the most common reason given for not making the data available was that long-term follow-up data was still being collected.

“This is the same reason given by Pfizer and Moderna for the clinical trial data on their respective COVID-19 vaccines not currently being available,” he said.

“However, this excuse disregards any commitment to data transparency. Ongoing follow-up is of course needed, but it should not hinder the release of the key data that is implicated in the global release of medicines.”

People pose with syringe in front of the displayed Pfizer logo in this photo, taken on December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

Worryingly, the study found that for three of the world’s best-selling anti-cancer drugs—nivolumab, pembrolizumab and pomalidomide—90 percent of the trial data was unavailable, and in Australia, the former two are the most expensive chemotherapy drugs for the Australian taxpayer, at a cost of $800 million via the government’s Pharmaceutical Benefits Scheme in 2020-21.

Hindering Further Research

PhD candidate and study lead author Natansh Modi said the need for ongoing verification of clinical trial claims is a critical reason for data transparency, but it is also important for follow-up research.

He stressed that evidence suggests requests for data are most often made to gain new insights into the benefits and risks of medicines in unexplored patient groups.

“This aspect of research upholds the social contract that the industry enters into with trial participants, whereby they are told their participation will allow for further research to maximise the benefit to society,” he said.

“If the data isn’t made available, it can’t be put to good use. Trial participants and their families deserve better.”

Therefore, the researchers are calling on the pharmaceutical industry to come to the party by explicitly stating in their policies that trial data used to approve medications will be made available for independent investigation immediately after the drugs are registered.

“Emerging policies drafted by the pharmaceutical industry offer an unparalleled opportunity to advance evidence-based medicine, support decision-making, and protect the community,” Modi said.

“It is time that global regulators, governments, and journals establish mandates for data transparency on all major trials investigating registered medicines. Their purpose must be to protect and maximise public health and ensure the contributions of trial participants and their families reach their full potential.”