A Huge Amount of Data From Cancer Trials Remains Hidden, Researchers Warn



A frightening new research that evaluated over 300 clinical studies supporting anti-cancer medications licensed by the US drug agency during the previous 10 years found that data from more than half of cancer trials supporting drug approvals remain unavailable.

Only 45% of the 304 industry-sponsored clinical trials that produced the data for the 115 anti-cancer medications that the US Food and Drug Administration (FDA) approved between 2011 and 2021 had publicly shared patient-level data, or had promised to do so when the researchers enquired about access to the data.

Additionally, the analysis discovered that less than one-tenth of studies referenced on the product labeling of three of the most popular anti-cancer medications made individual patient data accessible.

For studies known as meta-analyses, which pool data from published trials to assess the balance of evidence for novel and current therapies, sharing anonymised individual patient data is essential. This data must be stored in secure data portals and be deidentified to safeguard participant privacy.

According to pharmacist and study author Natansh Modi of Flinders University, "Pharmaceutical corporations are not likely to share this data to other pharmaceutical companies due to competitiveness, thus this work has to be done by independent researchers."

In addition to allowing for meta-analyses, data sharing also enables researchers to duplicate experiments, utilise existing data, and confirm results that have already been published. All of these activities support increased public confidence in science.

Although progress has been made in the past five years to increase the transparency of [individual patient data], Modi and colleagues' findings "suggest that a significant portion of pivotal oncology trials that support the FDA registration of contemporary anti-cancer medicines remain unavailable to qualified researchers."

The US FDA, which licenses new medications and medical equipment, has undoubtedly faced criticism before.

Health experts recently protested the FDA's contentious decision to approve a new medicine for Alzheimer's disease, claiming industry-led clinical trials had not yet shown the antibody treatment, which is now available for about $56,000 per year, would decrease memory loss or cognitive decline.

The medicine had been authorized via the FDA's fast approval process, which allows the agency to do so based on scant evidence if a novel drug is deemed safe and there is a pressing need for better therapies for a particular ailment (although pharmaceutical companies must supply more efficacy data from real-world studies shortly thereafter).

The researchers behind this new study contend that although there are many reasons why clinical trial investigators might delay disclosing data from specific trials, the general public expects greater transparency from the billion-dollar pharmaceutical industry because it is their duty, along with drug regulators, to guarantee the safety and efficacy of new medications.

The study discovered that long-term follow-up of study participants was the most frequent reason corporate sponsors did not release trial data.

According to pharmacist and research author Ashley Hopkins of Flinders University, "Ongoing follow-up is, of course, important, but it should not prevent the release of the critical data that is implicated in the worldwide delivery of medications to tens of thousands of patients."

Meta-analyses are inherently unreliable when only summary-level data from trials are used because researchers cannot interrogate raw data, which could accidentally let flawed studies slip through the cracks, as it did in the case of ivermectin, and skew the outcomes of data-crunching, sense-making meta-analyses.

Jack Lawrence and four colleagues exposed the flawed studies in Nature Medicine, writing, "A poorly scrutinized evidence base supported the administration of millions of doses of a potentially ineffective drug globally, and yet when this evidence was subjected to a very basic numerical scrutiny it collapsed in a matter of weeks."

Based on their research, Modi, Hopkins, and associates are urging increased data availability for pivotal studies "to safeguard and enhance public health and guarantee the contributions of trial participants and their families optimize public health."

Modi continues, "The data cannot be used effectively if it is not made available.

Scientific publications and organizations that sponsor research have recently enacted regulations requiring or requiring the sharing of data among researchers. The American and European pharmaceutical associations also agreed in 2014 to provide requested anonymized trial data.

Although some researchers claim that during the epidemic, researchers' intents to share data changed noticeably, it seems that data transparency problems still exist, at a time when public confidence in science is required more than ever.

JAMA Oncology published the study.

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