Case Study Four

Utilizing a Network of Experienced Research Investigators in Community Clinics to Boost Enrollment Saves Time and Costs.

Synopsis:

The Pharmatech Oncology Network was pivotal in completing an ongoing vaccine trial which had fallen far behind scheduled enrollment. By implementing a coordinated multi-center plan involving our experienced investigators, the study was finished 8 months ahead of its revised target date, and with a cost savings to the sponsor of several hundred thousand dollars.

Case Study:

Background: A large pharmaceutical company was enrolling immunocompromised patients into a Herpes Zoster (HZ) vaccine study. Three major indications were targeted for study 1) patients with HIV, 2) patients with solid tumors and 3) patients with hematologic malignancies. Patients with HIV were enrolled on schedule, while patients with cancer tumors were lagging significantly behind the enrollment plan. Pharmatech Oncology was contracted to identify and support a number of study centers capable of enrolling patients to the two cancer arms.

Pharmatech Oncology Network: Pharmatech Oncology has built the largest oncology research network in the US, consisting of more than 200 practices and over 1200 physicians. The network is 85% community based and includes several academic, private, and military hospitals. Participating research centers must meet certain qualifications of experience, dedicated research personnel, and facilities among other things in order to join the network.

Study: Pharmatech Oncology joined the vaccine study after the sponsor realized that they would not reach enrollment targets for the two cancer treatment arms. Pharmatech Oncology was contracted to enroll 50 patients from 15 traditionally opened sites. (The study design did not allow for utilization of our Just-In-Time acceleration system). A revised set of target dates for full patient enrollment were set; September 2009 for the solid tumor arm and May 2010 for hematologic arm.

Results: Pharmatech Oncology Network sites were opened in the Spring of 2009. Extensive sponsor administrative requirements made the site selection and activation process slower than usual. Our standard is to open traditionally managed sites within six weeks following initial selection. Pharmatech sites enrolled their first patients to the study in late April, and thereafter a steady enrollment of approximately 15 patients per month from 15 sites took place through mid September, when both cancer treatment arms were completed. Overall Pharmatech Oncology investigators enrolled 62 patients, 24% over contract. Full enrollment of the solid tumor arm was completed 1 month ahead of schedule, and the hematologic arm was completed 8 months ahead of schedule.

Discussion: By developing a coordinated, multi-center enrollment plan involving carefully selected, experienced investigators the Pharmatech Oncology Network, our investigators easily completed what had been a challenging trial to the sponsor, 8 months ahead of their revised schedule. The sponsor considered Pharmatech as a rescue solution to lagging enrollment and with serious concerns that the cancer arms of the study were clinically unfeasible. Rapid turnaround of enrollment and completion of the trial saved several hundred thousand dollars to the sponsor and ensured that the trial objectives could be evaluated for cancer patients.

The study centers originally used for the study were selected by the sponsor. These were all larger research hospitals and academic centers. The study centers added by Pharmatech Oncology were all typical community practices with an average of 4-5 physicians. These smaller research practices outperformed the larger hospitals in the 5 months it took to complete the trial by 62 subjects to 33 enrolled by the major centers.

Conclusions: Community based research centers are a major resource for patient accrual of oncology clinical trials. 80% of all cancer patients in US are treated in community practice. Many private practice oncologists have a genuine research interest and in offering the latest treatment options to their patients. Therefore Pharmatech Oncology has specialized to organize and coordinate a large network of oncology investigators for the purpose of efficiently conducting oncology clinical trials. Only 3-5% of adult cancer patients in the US participate in clinical trials, and most are never offered the opportunity. Pharmatech Oncology has the vision that all patients treated within the network shall have at least one clinical trial made available as a treatment option in the course of their care.