As precision medicine advances, clinical research is increasingly focused on the personalized treatment of patients in niche populations. In a recently published article, we examined how this targeted approach to drug discovery and development relies upon biomarkers. In oncology and rare diseases, these biomarkers often have low prevalence, challenging researchers and drug developers to employ creative approaches for identifying eligible patients.
Of the more than 1,500 potential oncology biomarkers that have been identified in the preclinical setting, approximately 700 are being studied in active or planned clinical trials. The majority of these trials are for immuno-oncology drugs.1 Biomarker-driven studies have a higher likelihood of approval but may be more resource-intensive and less efficient due to the effort involved in recruiting and enrolling participants.
Biomarkers are now commonly used in every stage of drug discovery and development. A recent analysis found that ~55 percent of all clinical trials in 2018 involved the use of biomarkers. Nearly half of these included two or more biomarkers, which can make study eligibility even more challenging. There are, however, strategies for increasing the efficiency of recruitment and enhancing enrollment in these complex clinical trials.
To read the entire article and learn more about Precision for Medicine’s comprehensive and integrated solution to accelerating recruitment in biomarker-driven oncology and rare disease clinical trials click here:
1. BIO, Informa Pharma Intelligence, QLS Advisors. Clinical Development Success Rates and Contributing Factors 2011-2020, February 2021. Available at https://go.bio.org/rs/490-EHZ-999/images/ClinicalDevelopmentSuccessRates2011_2020.pdf.