Pharmaceutical and diagnostic company Prometheus Laboratories has granted an oncology programme to Clinipace Worldwide, a global digital research organization (dCRO).
As part of the contract, Clinipace Worldwide will study Proleukin (aldesleukin) and Vemurafenib therapy in patients with metastatic melanoma (mM).
The study with a sample size of 135 patients in the naïve patient arm, will enroll patients over an 18-month period, with additional follow-up of two years required.
The second study will enroll nearly 120 patients and compare the sequence of high dose Proleukin (aldesleukin) and 3mg/kg Ipilimumab immunotherapy in patients with metastatic melanoma.
Prometheus Laboratories clinical operations director Todd Butler said patient enrollment is one of the biggest challenges when starting an oncology trial; thus, it was critically important for the company to team with a CRO that could provide oncology expertise along with a robust electronic data management platform.
“We will be able to monitor our studies to ensure they are on track right from the start, specifically, the number of patients enrolled at each of our sites, as well as factors that impact enrollment and protocol compliance,” Butler added.
Clinipace Worldwide chairman and CEO Jeff Williams said embracing technology can be on one of the most powerful and cost-effective ways to enhance the success of a clinical trial.
“By partnering with a digital clinical research organization (CRO), you can be assured of safer trials, and higher quality data delivered more efficiently and cost-effectively,” Williams added.