Expert Insights

Expert Insights

How to Develop a Successful Precision Medicine Study

How to Develop a Successful Precision Medicine Study
21 April 2021

Scientific and technological advances have contributed to a phenomenal rise in precision medicine therapies over the past decade. According to the Personalized Medicine Coalition (PMC), more than one of every four FDA-approved drugs from 2014 to 2019 was a personalized medicine. In 2020, personalized medicines accounted for 39% of all FDA new drug approvals.

While factors such as unclear or conflicting regulatory environments among regions could impact clinical trials for targeted therapies, sponsors and biotech CROs can adjust many aspects of study design to improve the odds of success.

Alternative Endpoints for Phase I

Toxicity, presumed to increase with drug dose, is the conventional primary endpoint for Phase I clinical trials involving cytotoxic agents. Because molecularly targeted agents modulate specific abnormal cancer cells while sparing normal tissue, toxicity and efficacy may not be dose dependent. Alternative endpoints such as inhibition in tumors may be better suited to Phase I trials for targeted cancer therapies.

Integrated Biomarker Strategy

For cancer treatment, biomarkers can be used not only to diagnose disease and assess risk, but also to evaluate and monitor the effectiveness of a targeted therapy. Once classified, a biomarker-based companion diagnostic can be combined with targeted therapy to create a successful precision medicine formula.

To manage expectations and ultimately deliver studies on time and on budget, robust feasibility analysis should be performed. Consider all stakeholders — patients, sponsors, CROs, and sites — when performing these assessments. When done right, these assessments can help sponsors set realistic budgeting and recruitment goals.

Download the Synteract Precision Medicine Guide to Learn More

For a deeper look at how to optimize your precision medicine clinical trial from study design through feasibility, download our guide: Successful Study Design in Precision Medicine.

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