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Only 11% of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within required timeframes. TrialAssure is offering a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing their clinical trial results in a cost-efficient manner, thus avoiding penalties for non-compliance. (CLINICAL RESEARCH NEWS)
A New York University faculty member and a former U.S. Food and Drug Administration official have filed a lawsuit against the FDA saying that the Final Rule creates requirements for registering clinical trials and reporting their results, but it does not go far enough. It does not comply with the Food and Drug Administration Amendments Act insofar as it exempts certain trials from the Act’s registration and reporting requirements, and the government does not post noncompliance notices on ClinicalTrials.gov. (LAW360)
Photo: Peptide epitope of CD20 bound to Rituximab FAB. The American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC) have issued recommendations on Trial Reporting in Immuno-Oncology (TRIO). These recommendations are intended to improve the reporting of immune-oncology clinical trials and provide more evidence on the benefits and risks of this approach. Standardizing how trials are reported will also allow us to compare different immune-oncology trials. (cancernetwork)
A recent study published in the British Medical Journal found that results of oncology clinical trials published in major medical journals were described using vague terms that downplayed harms associated with cancer drugs, which was at odds with side effects observed in the actual data. Journalists also use these “vague terms” that minimize potential harms, while emphasizing and exaggerating the potential benefits of new health care interventions. (healthnewsreview.org)
New transparency rules which require the registration of a clinical trial before any results of the trial become available are a response to public pressure. The patenting situation in the U.S. does not appear to have severely worsened since the introduction of the transparency rules. In Europe, however, revised transparency regulations have negatively impacted investigators’ ability to protect clinical trial-related inventions by patents. (nature.com)
In a recent study published in the Royal Society of Medicine, the authors examined protocols they received from research ethics committees to evaluate whether the trials were ethical and whether essential information had been hidden from the patients. However, there were such widespread redactions in the protocols they received that they found them useless for assessing the ethical justification for the studies. (SCIEN MAG)
Shire has adopted a new transparency policy whereby it will publish Shire-supported research manuscripts only in journals that allow free public access. Shire may be the only biotech/pharma company that has such a policy, which covers preclinical, clinical, and post-marketing data. (BioCentury)
As the industry works to increase transparency in clinical trial data reporting, researchers have found that data on adverse effects remain largely unpublished. (outsourcing-dharma.com)