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The Rise of Risk Based Monitoring [Infographic]

Thomas Underwood

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? 

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Topics: Clinical Trials, Remote Monitoring, Electronic Data Capture, e-Clinical, Source Data Verification (SDV), Adverse Events (AEs), On-Site Monitoring, Serious Adverse Events (SAEs), Clinical Trial Phases, Additional Monitoring, Phase 2 Studies, Technology Trends, CRAs, Risk Based Monitoring

Is Lack of Data the Biggest Challenge for Early Phase Pharmacovigilance?

Pharmacovigilance Team

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.

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Topics: Regulatory Requirements, FDA, Phase I Studies, Adverse Events (AEs), Pharmacovigilance, Serious Adverse Events (SAEs), Clinical Trial Phases, Oncology

The Rise of Risk-Based Monitoring in Clinical Trials

Thomas Underwood

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[1]. The unproductive travel time saved also means CRAs have more time available for monitoring activities, aiding with the current CRA shortages[2].

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Topics: Clinical Trials, Remote Monitoring, Electronic Data Capture, e-Clinical, Source Data Verification (SDV), Adverse Events (AEs), On-Site Monitoring, Serious Adverse Events (SAEs), Clinical Trial Phases, Additional Monitoring, Phase 2 Studies, Technology Trends, CRAs, Risk Based Monitoring

Conducting Randomization in Clinical Trials [VIDEO]

Statistical Consultancy Team

 

When running a clinical trial the industry standard is a double-blind placebo‑controlled parallel group trial. This is because it is the best way to ensure that the characteristics of subjects in each treatment group are the same, whilst ensuring the investigators cannot anticipate the treatment of a subject.

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Topics: Clinical Trials, Statistical Programming, Randomization, Clinical Documents, Serious Adverse Events (SAEs)

The Challenges of Writing Patient / Safety Narratives

Medical Writing Team

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.

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Topics: Case Report Form (CRF), Adverse Events (AEs), Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Serious Adverse Events (SAEs), Patient Narratives, Safety Narratives, Data Clarification Form (DCF), Quality Control

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, CDISC, FDA, Standardization, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), Randomization, SAS Programming, On-Site Monitoring, Serious Adverse Events (SAEs), Quality Control, Visualization, Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

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