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Adaptive designs for clinical trials

Nirmalan PK. Adaptive designs for clinical trials. Kerala J Ophthalmol 2021;33:29-32

The gold standard for interventional studies is the randomized controlled trial (RCT). The RCT follows a linear path with prespecified plans and a little option for flexibility within its implementation. The RCT is also resource and time-intensive and can be a limitation in epidemics or pandemics where more rapid responses can reduce adverse effects. Adaptive designs (ADs) allow for continuous evidence-based modifications to key elements of trial design even as data collection is going on. Reduced use of resources, reduced time to complete the trial, flexibility in the allocation of participants to study arms and improved likelihood for scientifically valid trial results are added advantages with AD. ADs can be applied from early-phase trials to confirmatory trials. In this paper, we introduce the key aspects of AD that Ophthalmologists can apply to clinical trials in Ophthalmology. We briefly introduce the rationale for AD, commonly used terminology, and design elements.

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Dr Praveen Nirmalan

Written by Dr Praveen Nirmalan

Dr. Nirmalan did his basic medical education from Thrissur, Kerala and followed it with a PG Diploma in Ophthalmology from Aravind Eye Care System, Madurai and a Vitreo-retinal Fellowship from Mumbai. Subsequently, he completed his MPH and a Public Health Ophthalmology Fellowship from the Johns Hopkins School of Public Health in the USA. He has led community-based and clinical research in some of the top eye care institutes of India and led a clinical research program at a top tier obstetric and neonate institute as well. He has experience chairing Ethics Committees and has helped with the setting up of Institutional Review Boards. Besides mentoring clinical faculty, he has mentored DNB and PhD students through their dissertation work and research methods.

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