In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success.
Risk Based Monitoring is a term that is not new to the pharmaceutical industry. With increasing demand for budget reduction and reduced time to submission in drug development, both sponsors and vendors are seeking ways to reduce costs whilst still maintaining and potentially improving the quality of the data collected in clinical trials. Study costs can rise considerably for clinical trials with a large number of sites, especially across multiple countries. Risk Based Monitoring can reduce study costs considerably as there is a reduction in the need for CRAs to travel to sites, especially when coupled with a remote monitoring component. Also a reduction in the need to monitor all clinical trial sites and 100% of trial data, as those which are identified as more risk prone are visited more frequently according to targeted or triggered formulas. Even the FDA understands and encourages the desire to move away from 100% source data verification. Why therefore is the general mind-set in clinical operations exhibiting a degree of inertia to change with regard to RBM techniques?
We recently hosted a webinar on the challenges of Pharmacovigilance in early phase clinical trials. During the registration process we had the chance to survey members of the industry, 70% of the respondents were from pharmaceutical, biotechnology or medical device companies. We wanted to present the data from the 150 respondents in this blog.
During drug development the cost of clinical trials can rise significantly for studies that require several monitoring visits across multiple sites. Traditional monitoring techniques account for a large portion of these costs. Pharmaceutical companies absorb the costs of travel when their own Clinical Research Associates (CRAs) visit sites, while CROs normally charge clients these travel costs as pass through charges. It is estimated that remote monitoring in clinical trials could reduce travel costs (including unproductive time spent travelling) by up to 30%, and in theory the practice should be scalable across small to large clinical studies over several clinical trial phases. The unproductive travel time saved also means CRAs have more time available for monitoring activities, aiding with the current CRA shortages.
Clinical Data Interchange Standards Consortium (CDISC) defines and manages industry level data standards that are widely used during the analysis, reporting and submission of clinical data. For instance, the Study Data Tabulation Model (SDTM) is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets. Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files.
There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. This blog describes the scope of narrative projects and outlines the associated challenges and provides some ideas to help you successfully manage narrative projects.
Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies. With this increase comes the enhanced pressure of effectively monitoring these trials.
Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency.
Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!
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