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International Clinical Trials

Credible Risk Management

Dr Gurdyal Kalsi of MDS Pharma Services assesses the value of clinical trial data monitoring committees taken from the contract research organisation perspective

The creation of data monitoring committees (DMCs), also known as data and safety monitoring boards, is almost a routine practice in randomised control trials performed specifically to register a human medicinal product. The primary purposes are to protect the patient participating in a trial setting and to uphold scientific credibility for the conduct of an experiment.

Several incidents recently reported in the media have led to product withdrawals and appear to be altering public perceptions around the rigours of conducting experiments on investigational agents in humans. The marketing of a product is based on a treatment effect size, established in a controlled setting, and safety, characterised in a limited pool of patients. In an era of evidence-based medicine, the accumulation of data across a number of trials may contradict an initial impression of stronger findings.

Furthermore, prospective observational and epidemiology study data may receive scientific and media interest far in excess of the original cited clinical research. What is more important than media hype is determining the need for a DMC based on predictable risks to trial participants. They provide a review opportunity at an early stage as part of a continuous risk management plan, thereby helping to counteract potential controversies related to the extent of due diligence afforded to known risks.

GUIDELINES

The establishment of a DMC must take into account a number of bodies and regulations: the relatively new EMEA Committee for Medicinal Products for Human Use guideline, effective from January 2006; guidance for clinical trial sponsors issued by the Food and Drug Administration (FDA); National Institutes of Health (NIH) policy for data and safety monitoring; World Health Organization (WHO) operational guidelines on DMCs; and the DAMOCLES (Data Monitoring Committees: Lessons, Ethics, Statistics) study group publication. (The DAMOCLES study group performed a comprehensive review of published literature on DMCs and developed a charter that covers all operating practices and procedures.) In addition, the International Conference on Harmonization (ICH) notes for guidance E3, E6 and E9 are considered relevant reading.

HOW TO ASSESS NEED

In the world of contract research organisations (CROs), clients often ask about the need to establish a clinical data monitoring committee. How can CROs help with the practicalities of running a DMC that monitors effectiveness and safety outcomes, and also makes recommendations that meet patient safety and regulatory requirements?


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Dr Gurdyal Kalsi is a Senior Pharmaceutical Physician with 15 years of experience in R&D assignments across biopharmaceutical drug and device engagements. Trained in Pharmaceutical Medicine from Cardiff University, UK, Gurdyal has been invited to present to various international congresses and seminars on pharmacovigilance and drug development topics. Gurdyal provides training in drug development, drug surveillance, medicines regulation and risk management. He is currently responsible for global provision of medical affairs and pharmacovigilance services within the global clinical development division of MDS Pharma Services
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