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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

The Different Phases of Clinical Trials

Medical Writing Team

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans.  These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years.  Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Pre-Clinical Study, Clinical Trial Phases, Phase 3 Studies, Phase 4 Studies, Phase 2 Studies

A Guide to Phase 1 Clinical Trial Designs

Statistical Consultancy Team

The primary aims of Phase 1 clinical trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound.  Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Phase I Study Design, Clinical Trial Phases, Phase 3 Studies, Peadiatric Assessments, Bioequivalence, Drug-drug Interaction, Bioavailability

Bayesian Methods and a review of the European Statistical Forum

Statistical Consultancy Team

A member of Quanticate's Statistical Consultancy Team writes about their attentedence and presentation at the European Statistical Forum, Milan Nov, 2011.

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Topics: Regulatory Requirements, Bayesian Statistics, Bayesian Study Design, European Statistical Forum, Bayesian Methods, Survival Analysis, Interim Analysis, Biostatistics Consulting, Clinical Trial Phases

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