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26

Organization Helps Pharmaceutical Companies Reach Higher Level of Clinical Trial Reporting

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Label: Featured News


MesotheliomaHelp has reported many times on the importance of clinical trials and the positive impact they can have on mesothelioma patients. The results have impacts beyond the patients in the trial by helping researchers and the medical community make the right decisions regarding treatments. Many times, though, these results are not made publicly available. Now, Bioethics International is working hard to ensure that pharmaceutical companies understand the impact trial results, whether positive or negative, can have on the medical community, and are helping them make their clinical trials transparent.

In a Dec. 20 interview with Moira Gunn on NPR’s BioTech Nation, Dr. Jennifer Miller, Founder and President of Bioethics International, reported that the general rules for clinical trial transparency require that pharmaceutical companies report the results of their clinical trials 30 days after the drug is approved by the U.S. Food and Drug Administration. However, the approval process is long and arduous, and rarely is there any interim trial reporting. If a drug is not approved, chances are low that anyone outside of the pharmaceutical company will ever see results.

Bioethics International is preparing to release its second iteration of its Good Pharma Scorecard (GPS), a ranking of pharmaceutical companies based on their clinical trial transparency score, according to the ethics standard that all trial results should be publicly available to contribute to “generalizable knowledge.” The ranking information is applauded by the mesothelioma community as researchers struggle to gain access to critical data that can help drive future research. In 2012 when Bioethics released its first GPS, just 20% of final trial results were published.

“The number one reason people participate in clinical trials is that they want to contribute to generalizable knowledge,” said Dr. Miller. “In order to make sure we continue to involve people in clinical trials we have to make sure the results are publicly disclosed.”

Dr. Miller, who is also an Assistant Professor of medical ethics and population health at NYU School of Medicine, spent four years at Harvard University ensuring that the compliance rules and regulations for reporting clinical trials are fair and easy to understand. Dr. Miller and her team work closely with the pharma-industry explaining and adjusting scorecard ratings so that, ultimately, pharmaceutical companies can achieve 100% compliance, bringing valuable data to the general public.

Dr. Miller’s goal is to have the data available as generalizable knowledge for all patients, the medical profession, doctors and fellow researchers so that the information is shared. Dr. Miller explained that when drugs are approved the dosing information is guided by trial results.

Using available results data, “Physicians can prescribe the right drugs, to the right patients at the right time,” says Dr. Miller. “They need all of the medical evidence as they prescribe based on patient guidelines that are gleaned from the clinical trial results.”

Researchers are closely following Dr. Miller’s initiatives in order to help them cut their costs. The researchers report they could lower research costs if they could find data from trials that were previously conducted. Many times they recreate trials and tests due to inadequate reporting from previous trials run for the same drugs and scenarios.

According to the National Institutes of Health, clinical trials are at the heart of all medical advances. Clinical trials serve to uncover better ways to treat, prevent, diagnose and understand human diseases. They provide mesothelioma researchers with critical information needed to allow them to move their findings from the lab to patients. They also offer patients access to a treatment that might not otherwise be available.

Doctors, pharmaceutical companies and patients rely on the results of clinical trials for a breakthrough treatment for medical conditions and for understanding drawbacks for the medications. Without complete, accurate data, though, mesothelioma patients and their oncologists cannot make informed decisions.

Find out more about how you can help get trial results published by visiting AllTrials.net, a UK organization dedicated to bringing transparency to clinical trials. AllTrials is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science and is being led in the US by Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice.

To find out more about Bioethics International and its Good Pharma Scorecard see Bioethics International.

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