A secrecy agreement that has been around for a long time in the pharmaceutical industry is being disintegrated. Last week, pharmaceutical giant GlaxoSmithKline (GSK) announced that it will systematically provide researchers with a detailed treasure trove of raw data that is the basis of its clinical trials, which has won the applause of scientists. GSK ’s actions are the first such commitments made by big players in the industry, and this is just the beginning. The European Medicines Agency (EMA) intends to open access to all new clinical trial data sets obtained from companies for product registration from next year.
This decision represents a radical change in clinical science. Joseph Ross, a researcher at Yale University School of Medicine, said data sharing from genomics to particle physics is taken for granted, but data from clinical trials is rarely fully shared with other scientists. This means that doctors, health officials and researchers are forced to make important decisions about patients and healthcare based on incomplete, sometimes biased information. GSK's decision affirmed the extensive value of the original trial data to researchers and public health officials. GSK's move is a big step forward for the public.
The greater openness of clinical trial data should help accelerate drug development, provide independent assessment of drug safety and efficacy, and increase trust in industry science. It also has the potential to put an end to scandals. In the past few years, it has been seen that almost all large pharmaceutical companies have suffered hundreds of millions of dollars in fines for placing profits before patient safety and welfare, usually by selectively reporting data. In July of this year, GSK paid US authorities $ 3 billion for fraud, including the publication of "false and misleading" test reports, hiding data on security issues. This payment covers the antidepressants Paxil (paroxetine) and Wellbutrin (bupropion), and the diabetes drug Avandia (rosiglitazone).
GSK now intends to provide anonymous patient data for all trials that have been approved and discontinued since 2007. (The company said that only data formats after 2007 are suitable for sharing). It will establish a panel of experts at a distance from the company to review requests for access to scientific value data, and some researchers have expressed dislike of this restriction.
James Shannon, GSK's chief medical officer, believes this restriction makes sense to prevent people without reliable scientific questions or assumptions from accessing the data. Such fishing trips may lead to flawed analysis, cause unnecessary panic among the public, and damage public health.
Wait and see
Peter Gøtzsche, director of the Nordic Center for Forensic Medicine, said he has several "big problems" with restrictions. He believes that this may lead to arbitrary decisions on the release of data, which may benefit the company rather than the public interest. The risk of any panic outweighs more attention to data, and insufficient data sharing in industry trials will be "more harmful."
Kay Dickersin, director of the clinical trial center at the Bloomberg School of Public Health at Johns Hopkins University, agrees with GSK that some access restrictions may be helpful. She warned that the value of GSK ’s new openness will ultimately depend on the details of how much patient-level data it provides, and more importantly, the level of reference materials, how experiments are designed, and how data is collected, processed, and analyzed. "Let's wait and see," she said.
Next year will take another measure to further openness, when EMA began to publish the clinical trial data set submitted to it. Although most companies are likely to treat the data as confidential, EMA senior medical officer Hans-Georg Eichler said that the European Ombudsman's 2010 rules propose that the public health benefits of EMA trial data exceed commercial interests.
EMA's plan is "an extraordinary step in the right direction," Ross added. In contrast, the US Food and Drug Administration considers the raw data from the trial to be a trade secret.
Referring to the scandal that has shaken the pharmaceutical world, Shannon said the transparency his company is exploring is the only way out for the industry, and he hopes other companies will follow GSK. In order to maintain the "operating license" from society, he said that the pharmaceutical industry had to move towards full disclosure. Many ordinary members of the GSK company have long sought more clinical data sharing. Last week's announcement received "many internal praises" and was praised by some GSK scientists as "dreams come true."
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