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ClinicalTrials.gov not living up to promise

Clinical researchers in the US are required to register trials and deposit trial information at ClinicalTrials.gov. Most, however, don’t. According to several recent study, compliance with this law may be somewhere between around 13 and 22 percent. Which is to say that of the 13, 327 clinical trials conducted between 2008 and 2013, only 1,790 were filed on  ClinicalTrials.gov, leaving 11,537 unreported. Says author Kent Anderson in this March 3,…

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Sharing Clinical Trial Data

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of…

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Results Of Many Clinical Trials Not Being Reported

Many scientists are failing to live up to a 2007 law that requires them to report the results of their clinical trials to a public website, according to a study in Thursday’s New England Journal of Medicine. The website is clinicaltrials.gov, which draws 57,000 visitors a day, including people who are confronting serious diseases and looking for experimental treatments. A study from Duke University finds that five years after the…

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New video aims to reduce misconduct in clinical trials research

The Research Clinic, a Web-based interactive training video aimed at teaching clinical and social researchers how to better protect research subjects and avoid research misconduct, was released today by the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) and Office for Human Research Protections (OHRP). The video lets the viewer assume the role of one of four characters and determine the outcome of the storyline by…

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Johnson & Johnson opens clinical trials data

Drug companies tend to be secretive, to say the least, about studies of their medicines. For years, negative trials would not even be published. Except for the U.S. Food and Drug Administration, nobody got to look at the raw information behind those studies. The medical data behind important drugs, devices, and other products was kept shrouded. Today, Johnson & Johnson JNJ +0.67% is taking a major step toward changing that,…

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New guiding principles for clinical trial data sharing

Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing – if carried out appropriately – could lead to improved clinical care and greater public trust in clinical research and health care. Discussion Framework for Clinical Trial Data Sharing: Guiding…

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Improving clinical trials: 2013 workshop findings

“Significant opportunities exist to accelerate the use of LSTs [Large Simple Trials] to efficiently generate practical evidence for medical decision making and product development. Data for LSTs can be obtained from electronic health records (EHRs), whose increased adoption continues to be driven by the implementation of the Health Information Technology for Economic and Clinical Health Act, which pays incentives to hospitals or eligible office-based professionals if they demonstrate use of…

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‘Master protocol’ aims to revamp cancer trials

In the push to match medical therapies to the genetic underpinnings of disease, lung-cancer treatments have been at the frontier. But the 1.6 million people diagnosed with this cancer every year will take scant comfort in knowing that of the past 20 late-stage trials of drugs to treat it, only two yielded positive results. And in only one of those 20 were patients chosen systematically by screening for biomarkers such…

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