Clinical Trial Development:
OEWG, RA’s Role,
and Activating Trials
on Deadline
Martha Heckel
Protocol Associate II, ACRIN
Dept. of Protocol Development
& Regulatory Compliance
Clinical Trial Development
Annual Meeting 2011
Overview of Discussion Points
1. Introducing the OEWG Timeline
2. The RA in Early Trial Development
3. Trial Activation and Ramp-Up Phase
Clinical Trial Development
Annual Meeting 2011
Introduction to OEWG
1. Introducing the OEWG Timeline:
• What is the OEWG?
• What is this about a timeline?
• How is it impacting ACRIN … the sites?
Clinical Trial Development
Annual Meeting 2011
OEWG … What?
What is the OEWG?
OEWG =
Operational Efficiency
Working Group
Established in 2008, the OEWG assessed
how the cooperative groups function …
and suggested changes.
Clinical Trial Development
Annual Meeting 2011
OEWG … Why?
Studies of timelines within the cooperative group
structure show our processes can be improved …
Dilts DM, Sandler AB. Activating and Opening Oncology Clinical Trials: Process & Timing Analysis. Available at:
www.iom.edu/~/media/Files/Activity%20Files/Disease/NCPF/Dilts.pdf; accessed September 7, 2011.
Clinical Trial Development
Annual Meeting 2011
OEWG Timeline
The OEWG and CTEP have
implemented target and
absolute deadlines for
concept development
through actual trial
activation.
Trial activation is defined as one site
ready to accrue participants.
Clinical Trial Development
Annual Meeting 2011
OEWG Timelines: Target
The OEWG guidelines
include hard drop-dead
dates depending on the
phase of the treatment trial.
Trial Phase
Target Deadlines
Absolute Deadlines
Phase I
210 Days
540 Days
Phase II
210 Days
540 Days
Phase III
300 Days
720 Days
Clinical Trial Development
Annual Meeting 2011
OEWG Timelines: Phases I and II
Target Milestones
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
ACRIN will adhere to the same timelines,
regardless of whether the trial is NCI
funded or funded by another source
(ACRIN Foundation, PA DoH, AHRQ).
ACRIN will always have to work within
OEWG structure for cooperative trials
with other groups (e.g., ECOG, GOG,
or RTOG).
Clinical Trial Development
Annual Meeting 2011
OEWG Timelines: Impact
Implications for ACRIN Procedures:
• More complete trial design prior to
CTEP submission.
• Less complex trial designs.
• Forms and ancillary documents must
be completed prior to activation.
– Medidata RAVE and standardization
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
What changes have ACRIN and NCI
introduced to meet the target deadlines?
A. Shift in timing (earlier, earlier, earlier)
B. Site membership
C. Scanner qualifications
D. Focus on
activation/recruitment
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
A. Shift in timing (earlier, earlier, earlier)
• Delivery of materials
to sites (protocol
summary, PSA, etc)
• Streamlined development/
completion of forms
• Advanced oversight of
contract negotiations
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
B. Site membership
• Centers for Quantitative
Imaging Excellence,
or CQIE Program
(advanced imaging
qualification program—NCI-designated
Cancer Centers only)
• ECOG/ACRIN and ECOG membership
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
C. Scanner qualifications
• CQIE (CT, MR, PET)
• ACRIN will be working with sites
to qualify imaging scanners using
CQIE standards
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
D. Focus on activation/recruitment
• Earlier description of trial to sites;
allow as much time as possible to
review and consider joining the trial
• Consideration of the multidisciplinary
team needed to perform the trial
• ECOG involvement will facilitate the
connection between oncology and
radiology as we join with treatment trials
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
D. Focus on activation/recruitment con’t
• Better understanding of sites’
processes, and how ACRIN can help …
• How many committees
at your sites must review
the protocol?
• On what timeline?
• How can
ACRIN help?
Clinical Trial Development
Annual Meeting 2011
OEWG and ACRIN
D. Focus on activation/recruitment con’t
• Review of PSAs by multiple ACRIN
departments and the trial PIs—
plans for accrual
• Make sure sites aware of all open
ACRIN trials
Clinical Trial Development
Annual Meeting 2011
After Trial Activation
TRIAL
ACTIVATES!
Clinical Trial Development
Annual Meeting 2011
During Early Trial Development
2. The RA in Early Trial Development:
– Design:
• Consider Role of RA Committee Rep
(Scientific and Procedural Input)
• Review of Protocol Contents
– Implementation at sites:
• Anticipate Obstacles to Avoid
Protocol Violations
• Ponder: What Tools Would Help Trial Process?
Clinical Trial Development
Annual Meeting 2011
RA Committee Rep’s Role
Trial assigned to
a representative
from the RA Committee
RA Committee reps
instrumental in
forms development,
which will have greater
impact going forward …
Clinical Trial Development
Annual Meeting 2011
Development and Implementation
Every RA has a role in trial development:
• Translation to local implementation
• Reasonable timelines for procedures
• Identifying pitfalls
(obstacles to study
compliance)
And let us know at any
time when you see
areas for improvement
Clinical Trial Development
Annual Meeting 2011
During Trial Development
Representative reviews the
protocol/forms from data
collection/operations perspective:
• How well are the procedures defined?
• Is the protocol consistent?
• What might be
confusing to
an RA (missing
details)?
Clinical Trial Development
Annual Meeting 2011
During Trial Development
How Can ACRIN Help You?
Help the Trial?
During trial development,
chime in with ideas to
assist the trial:
• Eligibility flip charts
• Patient handouts
• Screening log
Clinical Trial Development
Annual Meeting 2011
During Trial Development
“I have ideas! Who’s my contact?”
ACRIN’s Project Managers
and Communications team
leads the development of
recruitment and other
study-related materials.
Call Nancy Fredericks to get started!
Clinical Trial Development
Annual Meeting 2011
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.
Clinical Trial Development
Annual Meeting 2011
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 and training.
• Contact us any time if you
have specific feedback, e.g.,
see trends within a specific
trial or across ACRIN trials.
Clinical Trial Development
Annual Meeting 2011
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!
Clinical Trial Development
Annual Meeting 2011
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!
Clinical Trial Development
Annual Meeting 2011
Questions?
Clinical Trial Development
Annual Meeting 2011