Clinical Trial Development: RA’s Role, OEWG, and IRB Submissions Martha Heckel Protocol Associate, ACRIN Dept. of Protocol Development & Regulatory Compliance

Overview of Discussion Points The RA in Trial Development Introducing the OEWG Timeline Trial Activation and Ramp-Up Phase

During Trial Development 1. The RA in Trial Development: Consider Role of RA Committee Rep Review of Protocol Contents Anticipate Obstacles to Avoid Protocol Violations Ponder: What Tools Would Help Trial Process?

RA Committee Rep’s Role Trial assigned to a representative from the RA Committee RA Committee rep attends t-cons during trial development

RA Committee Rep’s Role We’re looking for your input. Need another good reason to join the RA Committee? Get involved in early trial development to offer your thoughts!

During Trial Development In reviewing the protocol, keep in mind: Language for clarity Reasonable timelines for procedures Identifying pitfalls (obstacles to study compliance) Thus, avoiding Protocol Violations

During Trial Development Representative reviews the protocol from data collection/operations perspective: How well are the procedures defined? Is the protocol consistent? What might be confusing to an RA (missing details)?

During Trial Development How Can ACRIN Help You? Help the Trial? During trial development, chime in with ideas to assist the site RAs: Eligibility flip charts Patient handouts What else?

During Trial Development “I have ideas! Whom do I speak with?” ACRIN’s Project Managers and Communications team leads the development of recruitment and other study-related materials. Call Nancy Fredericks to get started!

During Trial Development Trial Development Is an Ongoing Process The conduct of the trial is important! We hope you will join our Site t-con calls. Contact us any time if you have specific feedback— see trends within a specific trial or across ACRIN trials.

Introduction to OEWG 2. Introducing the OEWG Timeline: What is the OEWG? What is this about a timeline? How will it impact ACRIN and sites?

OEWG … What? What is the OEWG? OEWG = Operational Efficiency Working Group Established in 2008, the OEWG has assessed how the cooperative groups function … and suggested changes.

OEWG Timeline What is this about a timeline? The OEWG and CTEP have implemented revised timelines for concept development through actual trial activation. Trial activation is defined as one site ready to accrue participants.

OEWG Timelines: Target The OEWG guidelines include hard drop-dead dates depending on the phase of the treatment trial. Phase I = 210 Days* Phase II = 210 Days* Phase III = 300 Days* * Without Timeouts; Absolute Deadlines are 18 (phases I and II) and 24 months (phase III).

OEWG Timelines: Timeouts Time-clock stops for issues outside of NCI’s or PI’s purview (i.e., pharma approval, IRB review). Timeout time is NOT counted towards Target Milestones; however, it IS counted toward the Absolute Deadline.

OEWG Timelines: Phases I and II Target Milestones

OEWG Timelines: Phase III Target Milestones

OEWG Timelines: Impact General impact on trial development: Trial design must be more complete prior to LOI or Concept submission; LOI or Concept has 60 or 90 days to be approved (depending on phase); Protocol must be submitted within 60 to 90 days (depending on phase); ...

OEWG Timelines: Impact AND … Forms and ancillary documents must be completed prior to activation. Which is another time point when RA Committee members come in—deadlines for forms feedback may be compressed for adherence to the OEWG Timeline Milestones.

OEWG and ACRIN While CTEP is introducing the OEWG timeline for TREATMENT trials only, at this time, ACRIN will adhere to the same timelines. ACRIN will always have to work within OEWG structure for cooperative trials with other groups (e.g., GOG or RTOG).

After Trial Activation TRIAL ACTIVATES!

Submitting to Local IRBs 3. Trial Activation and Ramp-Up Phase Once the initial protocol is approved, ACRIN requests for local IRB submission no more than 30 days from receipt … maybe less depending on OEWG timeline! For amendments, ACRIN allows 60 days for protocol approval.

Submitting to Local IRBs “Why the push? Don’t we have 60 to 90 days for approval?” Yes, technically … But amendments are often in response to site feedback to eliminate accrual barriers or provide clarification. So, the sooner, the better!

ACRIN trials would not be successful without our dedicated RAs. Thank You ACRIN trials would not be successful without our dedicated RAs. Thank you all for your commitment to ACRIN trials and the people who participate. We couldn’t do it without YOU!

Questions? 9 April 2019