Researchers warn that a significant amount of data from cancer trials remains hidden

Researchers warn that a significant amount of data from cancer trials remains hidden ...

According to a shocking new investigation, data from more than half of drug studies that underpin drug approvals remains unaccessible.

Only 45 percent of the 304 industry-sponsored clinical trials that evaluated 115 anti-cancer medications approved by the US Food and Drug Administration (FDA) between 2011 and 2021 had publicly shared patient data or indicated that they would do so if the researchers requested data.

A further finding is that less than one-tenth of the research conducted on three of the top-selling anti-cancer medications included individual patient data.

For meta-analyses that combine data from published studies to assess the effectiveness of new and existing treatments, sharing individual patient data that isn't identified to protect participant privacy is vital.

"Pharmaceutical companies are not going to provide this information to other pharmaceutical companies because of competition, therefore this work must be done by independent researchers," said pharmacist and study author Natansh Modi of Flinders University.

"But it can't be done without data and transparency."

Researchers may use existing data, replicate research studies, and validate published findings, all of which helps strengthen public trust in science.

During the COVID-19 epidemic, rapid data sharing was priceless, forming public health decisions, and expediting research, treatments, and vaccinations.

"Although advances have been made in improving [individual patient data] transparency in the past five years, these findings suggest that a substantial portion of crucial oncology trials that support the FDA's registration of modern anti-cancer medications remain unavailable to qualified researchers," according to Modi and colleagues.

The US Food and Drug Administration, which approves new medicines and medical devices, has been scrutinized for the first time.

Health professionals cried out recently when the government's decision to approve a new medication for Alzheimer's disease sparked an outcry, claiming that industry-led clinical studies had not yet demonstrated that the antibody therapy, which is now on the market for around US$56,000 per year, would reduce memory loss or cognitive decline.

The drug had been approved under the FDA's accelerated approval process, which allows for, if an innovative new drug is considered safe and the therapeutic need for improved treatments for a given illness is considered great, the agency may approve it based on limited evidence (although pharmaceutical companies must provide more data from real-world studies shortly thereafter).

The researchers behind this new study argue that the general public expects greater transparency from the billion-dollar pharmaceutical industry that has a responsibility, along with drug regulators, to ensure the safety and efficacy of new medicines.

According to the study, the most common reason industry sponsors did not share trial data was because long-term follow-up of study participants was ongoing.

Ashley Hopkins, a pharmacist and study author at Flinders University, says, "Continuous follow-up is necessary, but it should not hinder the disclosure of crucial information that is implicated in the worldwide distribution of medicines to tens of thousands of people."

Meta-analyses are inherently unreliable because researchers are unable to interrogate raw data, which may, as it did in the case of ivermectin, accidentally allow flawed studies to slip through the cracks and skew the results of data-crunching, sense-making meta-analyses.

After discovering the flawed studies, Jack Lawrence and four colleagues wrote in Nature Medicine.

Modi, Hopkins, and colleagues are calling for more data transparency on pivotal research "to protect and maximize public health and ensure that trial participants and their families fulfill their full potential."

"It can't be used effectively if the data isn't available," Modi adds.

Scientific journals and research funding organizations have introduced policies that require or require data sharing among researchers in recent years. In 2014, the American and European pharmaceutical associations agreed to share anonymized trial data upon request.

Although some scholars have noted a notable shift in their intentions to disclose data during the epidemic, it appears that data transparency issues persist at a time when public trust in science is needed more than ever.

The research was published in JAMA Oncology.

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