A report from IQVIA has identified eight drivers of clinical development the company says will reach “peak impact” over the next two to four years.
Digital health technologies will capture drug efficacy and safety data remotely to improve patient safety, enable virtual trial formats and ease site burdens.
The availability of pre-screened patient pools and direct-to-patient recruitment will enable trials to meet enrollment targets, decrease trial duration and accelerate market availability.
Predictive analytics and artificial intelligence technologies and methods will help identify new clinical hypotheses, reduce trial risk and speed enrollment by identifying protocol-ready patients.
Increased focus on patient-reported outcomes will provide new insight into the patient experience, including drug efficacy and safety outside the clinical setting.
Real-world data will contribute to all aspects of accelerating clinical trials, from optimizing trial design to site selection, and will drive real-world evidence registries and serve as a virtual control arm for trials.
Use of targeted therapies and next-generation biotherapeutics — which have more than doubled over the past three years — also will speed trials and improve efficacy, as well as success rates. However, longer patient follow-up times will be required.
Biomarker testing will be used more widely to better target trial patient populations. The field is expected to yield a 34 percent increase across therapy areas and trial phases, with a corresponding success rate of 27 percent.
Regulatory support for precision medicine, as well as novel trial designs and endpoints, will contribute to accelerated drug approvals.