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Strategical Clinical Trials Towards Personalized Medicine: A Detailed Review

. Aneena Suresh, Dharshini M S, Pavithran T, Harish, Dharnish R and Arun Radhakrishnan


Personalized medicine is the novel highly utilized approach in recent drug development process. This method is implemented widely in the areas such as oncology, hematology etc. The personalized drug development process is also a tricky task which requires in-depth consideration and advanced toxicological screening.  RCTs (Randomized Controlled Trials) are the foundation of Evidence-Based Medicine (EBM). They have numerous advantages, but they also have certain disadvantages, as they are based on the norms of Good Clinical Practice (GCP). The rigorous methodology followed in RCTs provides for the avoidance of bias due to confounding factors (through a control group), selection bias (by randomization), and interpretation bias (via randomization) (through double blinding). In this review, we focus on the concept of personalized/precision medicine highlighting the history and the adaptation of traditional clinical trials as strategical to complement the personalized drug development process. Then, we look into the merits and demerits of strategical clinical trials in personalized medicine and give an overview of the future dimensions of these clinical trials in personalized medicine.

Keywords: personalized medicine, precision medicine, cancer, randomized clinical trial, strategical clinical trial, clinical trial

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