Mixed or dynamic trial design: New methodology of research for pharmacogenetics and pharmacogenomics studies

Advances in biotechnology and the completion of the human genome project have enhanced pharmacogenomics (PGT) and pharmacogenetics(PGM) where they can potentially revolutionize the field of therapeutics. 1‐ To explore and discuss the necessity of modifying the traditional paradigm for evaluating risk and benefit associated with therapeutic interventions where PGT and PGM advances have been applied. 2‐ To propose new methodology of research, which can be applied to PGT and PGM studies. An extensive search was conducted using medical information resources regarding the evaluation of pharmacogenetics and pharmacogenomics applications in the clinical trial setting. Published PGT/PGM trials on cardiovascular and rheumatology drugs demonstrate that the traditional methodology of clinical trials involving selection criteria, randomization, blinding and constant dose are inadequate in these kinds of studies. Traditional clinical trial methodologies are not readily applicable to PGT/PGM trials and alternatives methods need to be developed incorporating principles of epidemiology. This will be discussed in detail. Clinical Pharmacology & Therapeutics (2005) 77, P65–P65; doi: 10.1016/j.clpt.2004.12.138