Newsletter - January 21, 2016
Remote- and Risk-Based Monitoring Reduce the Need for CRAs in Clinical Trials
Clinical monitoring is the most expensive component of a clinical trial. More than half of the total budget of a given clinical trial is allocated for monitoring costs. Monitoring is essential for source data verification (SDV). Additionally, up to 80% of the time spent to manage a trial goes into the logistics and execution of monitoring. The CRAs (clinical research associates) tasked with monitoring account for more than 60% of a clinical trial team. Read More..
Most Clinical Trials Do Not Report Results on Clinicaltrials.gov
Since, 2007, it has been mandatory to register most clinical trials on the government clinical trial registry, clinicaltrials.gov. According to the same law, results of clinical trials must be posted within 12 months of the completion date. Failing to do either could lead to penalties of $10,000 per day till the violation is corrected. A survey of the clinical trials registered with clinicaltrials.gov indicates that only about 15% of completed studies have results reported for them; about 17000 out of 107000 completed studies. Read More..
Research Productivity: Who Discovers More, Academia or Industry?
Time and again it has been debated if the public funding into academic research is justified in terms of the “return on investment”, namely, does academia generates enough products for general use compared to the R&D labs in industry. In a recent opinion piece in Wall St Journal, it was suggested that scientific innovation is not driven by academic research but by technological evolution in our knowledge over time. Read more..
Remote- and Risk-Based Monitoring Reduce the Need for CRAs in Clinical Trials
Clinical monitoring is the most expensive component of a clinical trial. More than half of the total budget of a given clinical trial is allocated for monitoring costs. Monitoring is essential for source data verification (SDV). Additionally, up to 80% of the time spent to manage a trial goes into the logistics and execution of monitoring. The CRAs (clinical research associates) tasked with monitoring account for more than 60% of a clinical trial team. Read More..
Most Clinical Trials Do Not Report Results on Clinicaltrials.gov
Since, 2007, it has been mandatory to register most clinical trials on the government clinical trial registry, clinicaltrials.gov. According to the same law, results of clinical trials must be posted within 12 months of the completion date. Failing to do either could lead to penalties of $10,000 per day till the violation is corrected. A survey of the clinical trials registered with clinicaltrials.gov indicates that only about 15% of completed studies have results reported for them; about 17000 out of 107000 completed studies. Read More..
Research Productivity: Who Discovers More, Academia or Industry?
Time and again it has been debated if the public funding into academic research is justified in terms of the “return on investment”, namely, does academia generates enough products for general use compared to the R&D labs in industry. In a recent opinion piece in Wall St Journal, it was suggested that scientific innovation is not driven by academic research but by technological evolution in our knowledge over time. Read more..
