Protocol Life Cycle Subcommittee of the PRC (PLCS)
Protocol Life Cycle Subcommittee (PLCS) of the Protocol Review Committee (PRC) was established to monitor the scientific progress and accrual of active studies. The subcommittee consists of 6 members in addition to the chair consisting of YCC senior leadership and meets once monthly. Each Disease Aligned Research Team (DART) portfolio is evaluated every 6 months through DART leader presentations that provide the rationale, continued scientific validity, current status for each study, and anticipated time frame for completion for both active and pending studies; particular attention is given to the identification of potentially overlapping trials and prioritization. The Committee also notes the number of studies that are closed but not yet terminated, as these studies require continued regulatory support and resources.
In addition, each trial is reviewed for adequate accrual goals according to the target goals set by the PI. Low accruing studies will generate a letter to the PI asking for an explanation and plan to improve accrual. The PI must then direct the response to the Protocol Life Cycle Subcommittee Chair that stipulates plans for improving accrual rates and study completion timelines. An adequate response may include a change in methods for identifying patients and/or adding collaborating investigators. If there has been no improvement in 3-4 months after initial review, the study may be closed at the discretion of the full PRC based on the PLCS recommendation. Studies in rare, orphan populations or molecular subtypes may be granted additional time to accrue patients per committee discretion.
For information contact:
Dismayra Martinez, MHE, CCRP
Research Oversight Committee Regulatory Analyst
Yale Center for Clinical Investigation
2 Church Street South, Suite 112