``More than half of the clinical trial data of anticancer drugs are hidden,'' researchers warn
A study that audited more than 300 clinical trials of US regulatory-approved anticancer drugs found that more than half of the data in the trials that underpin their approval remain unpublished. .
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration | Oncology | JAMA Oncology | JAMA Network
Cancer researchers unable to access clinical trial data for top-selling drugs, study finds | Health | The Guardian
https://www.theguardian.com/australia-news/2022/jul/29/cancer-researchers-unable-to-access-clinical-trial-data-for-top-selling-drugs-study-finds
A Huge Amount of Data From Cancer Trials Remains Hidden, Researchers Warn
https://www.sciencealert.com/bulk-data-from-cancer-trials-remains-hidden-shocking-study-of-drug-approvals-finds
Pharmaceuticals used to treat illnesses are approved by the authorities after their efficacy and safety have been verified through rigorous clinical trials before being delivered to medical sites. In order for the contents of these tests to be verified by third-party organizations and for other researchers to refer to, the data must be open to the public. Therefore, a research team led by Natanshu Modi, a pharmacist at Flinders University, Australia, conducted a survey of clinical trial data of anticancer drugs approved by the US Food and Drug Administration (FDA).
The research team searched data from 304 clinical trials using 115 anticancer drugs approved by the FDA between 2011 and 2021, and found that 136 published anonymized patient data. Only 45% of the total number of cases, and the rest required months-long requests for information from pharmaceutical companies.
What's more, when we narrowed our focus to the top three best-selling cancer drugs,
To see how a life-saving drug, such as an anticancer drug, affects patients of different genders, ages, and races, researchers extract data from multiple trials of the drug. A large sample size is essential and such studies are called ' systematic reviews ' or ' meta-analyses '.
Because pharmaceutical companies do not share data with other pharmaceutical companies to compete, systematic reviews and meta-analyses must be conducted by independent researchers, but they cannot do so without making the data available to them. must be
'If researchers don't have access to clinical trial data, they can't systematically look at multiple trials,' Modi said. Is it safe and effective for me?”
The most common explanation given by pharmaceutical companies as a reason for not disclosing data was that the collection of long-term follow-up data had not yet been completed. “Continued follow-up is of course necessary, but early data showing the efficacy of a drug should not be used as a reason not to publish it,” Modi said.
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