Complex Approval Process for Phase III Clinical Trials

by: cancercompass

Gaining approval for phase III clinical trials is a complex process, according to researchers whose work can be seen in a study published online in the Journal of Clinical Oncology.

Researchers from various departments of Vanderbilt University, the Vanderbilt-Ingram Cancer Center and the National Cancer Institute examined the time it takes for the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and the Central Institutional Review Board (CIRB) to evaluate and approve phase III clinical trials.

Methods researchers used involved documenting steps that included interviewing CTEP and CIRB staff regarding the process from initial concept submission to trial activation by a cooperative group, reviewing standard operating procedures, and the inspection of trial records and documents from selected trials in order to identify any additional steps.

Researchers discovered there were at least 296 distinct processes required for phase III trial activations: "at least 239 working steps, 52 major decision points, 20 processing loops, and 11 stopping points."

In the past 8 years, researchers said the average time from initial formal concept submission to trial activation remained unchanged at about 602 days. They also concluded that because of the complexity of phase III clinical trials, the process is lengthy and highly variable and a solution would have to involve all the parties involved in developing trials.