Academics call for mandatory data sharing in oncology trials


10 Jul 2024

Data sharing for cancer clinical trials has improved greatly in the last 10 years but further changes are needed to ensure patient-centred care, medical advancements and trust in industry, according to Australian oncology  researchers.

Academics from Flinders University, Adelaide, say that mandated data sharing policies are needed for all industry-sponsored oncology trials to support future research, help prevent the duplication of studies, and ensure robust reviews and analyses can take place.

In commentary published in the Journal of Clinical Oncology (link here),  they say greater transparency rules are needed to guarantee independent access to clinical study reports and individual participant data from cancer clinical trials

“Participants often enrol in clinical trials knowing that while the trial may not personally benefit them, they are contributing to advancements in care for someone else in the future,” says lead author Natansh Modi , an NHMRC PhD candidate at the Clinical Cancer Epidemiology Lab at Flinders University.

“This can’t happen if the data that is needed to make these improvements isn’t made available to other researchers.”

In their article, Dr Modi and colleagues say that clinical study reports (CSRs) and individual participant data (IPD) are seen by several organisations, including the World Health Organization (WHO), as critical to building trust in the drug approval process and contributing to future drug trials.

However, despite containing detailed information on methods, results, and each participant’s responses to treatments, they are not generally accessible to researchers undertaking systematic reviews and meta-analyses.

“These types of studies ensure researchers can take all the information that is out there about a particular drug and treatment, review the evidence, and create guidelines and best practices for how doctors can best treat their patients,” said Mr Modi.

“But due to the unavailability of the data, it isn’t the norm to include CSRs and IPD, instead researchers must rely on summaries in published papers which are much less detailed, introducing a substantial risk of bias and compromising the review’s ability to improve patient care.”

Previous research by Mr Modi and his Flinders University colleague Associate Professor Ash Hopkins found that IPD was not available for more than half of the clinical trials that led to the United States Food and Drug Administration approval of certain anticancer medicines.

Despite an increase in the availability of CSRs and IPDS over the last 10 years or so, the authors say more needs to be done to further promote transparency.

“Pharmaceutical companies, funding bodies and journal publishers need to implement standardised data sharing policies that allow the data to be shared from the moment a drug is approved for use,” said Mr Modi.

There was also a need for independent review panels to be established to help eliminate conflicts of interest and bias when data sharing requests are made, he added.

“And while patient data protection is paramount, it has been found that 90% of trial participants support data sharing. As long as consent is there from the start, IPD should be shared to ensure trial data can be scrutinised.

“These changes require support from the many stakeholders involved in a drug’s development, but the ultimate goal is to create a data sharing ecosystem that prioritises scientific advancement and patient-centred care.”

The authors concluded that: “achieving these objectives is a collective responsibility involving multiple stakeholders, including journals, regulatory bodies, professional organizations, and the pharmaceutical industry, all of whom are in positions to implement and recommend policies that promote data sharing.

And while concerns about transparency in data sharing practices have focused on the pharmaceutical industry, the IPD perspectives were equally applicable to nonindustry/academic trial sponsors, they added.

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