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One Size No Longer Fits All: The Personalized Medicine Trial Landscape

 
• By Doro Shin

Success rates are higher for clinical trials that incorporate selective pharmacogenomics and pharmacogenetics (PGX) biomarkers, according to data from Informa's Trialtrove. Given the challenges of designing and administering trials to secure regulatory approval in areas of unmet medical need, the data provide some basis for optimism in realizing the promise of targeted, personalized therapies that improve health outcomes for individual patients.

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Although the standard of care for a disease (when one exists) generally has a well-established track record, it’s a one-size-fits-all remedy that may not be the best option for some patients. Medicine is entering a new era of personalization and the number of trials targeting specific subsets of patient populations continues to rise. The definition of “personalized medicine” or “precision medicine” varies, and can refer to an approach that incorporates insights on environmental and behavioral factors, in addition to a patient’s biology or genome, while informing disease treatment or prevention.

Some have a more specific view – personalized medicine leverages genetic profiles of patients to create tailored, more targeted interventions...

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