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International Clinical Trials

Role of Comparators in Clinical Trial Designs

Case studies provide real insight in how to choose comparators for rare diseases and oncology studies. Drug development is a very complex, long, and expensive process. Once a suitable molecule is identified, then clinical trials are undertaken to establish the effect of an intervention.

Treatment effects are efficiently isolated by controlling for bias, and confounding and minimising variation. Key features of clinical trials that are used to meet this objective are randomisation (possibly with stratification), adherence to intent-to-treat principles, blinding, prospective evaluation, and use of a control group. Compared to other types of study designs (e.g., casecontrol studies, cohort studies, and case reports), randomised trials have high validity, but are more difficult and expensive to conduct.

The gold standard of any scientific evidence is data generated from a randomised control trial. In these studies, a pool of patients is randomly assigned to two groups that receive different treatment. An experimental group will receive the investigational medicinal product (IMP) and a control group can receive a range of different interventions. The most commonly utilised are a placebo (an inert compound that has no effect on the endpoints measured) and an active comparator (usually the standard of care [SOC]) for the indication being tested for. The choice of medication for the control group depends on the nature of the disease. For example, oncology patients are always put on medication for ethical reasons.

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About the author

Dr Vanessa Dekou, Managing Director, Clinical Services International (CSI) has extensive experience in drug development from preclinical to registration and commercialisation strategies and has secured product registration for several orphans and first-in-class drugs. She has successfully designed and executed numerous trials all over the world. As such, Vanessa understands all the challenges and requirements of supplying comparators to clinical trials and ensuring trials are delivered on time and on budget. Vanessa has worked with some of the largest biopharmaceutical and biotechnology companies to provide innovative solutions. At CSI, Vanessa is responsible for providing bespoke solutions to their clients to ensure comparator sourcing is not a rate-limiting step in the successful delivery of trials. She also works closely with pharma manufacturers to safeguard the supply chain and remain on the front line of advances in drug development. Vanessa has a PhD in Cardiovascular Genetics from University College of London, UK, an MBA from Cambridge, UK and a Masters in Market Access from University of Lyon, France.
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