annual meeting 2011 clinical trial development clinical trial development: oewg, ra’s role, and...

Annual Meeting 2011 Clinical Trial Development

Clinical Trial Development: OEWG, RA’s Role,

and Activating Trials on Deadline

Martha HeckelProtocol Associate II, ACRIN Dept. of Protocol Development

& Regulatory Compliance


Overview of Discussion Points

1. Introducing the OEWG Timeline

2. The RA in Early Trial Development

3. Trial Activation and Ramp-Up Phase


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?


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.


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.


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.


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


OEWG Timelines: Phases I and II

Target Milestones


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).


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


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


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


OEWG and ACRIN

B. Site membership

• Centers for QuantitativeImaging Excellence, or CQIE Program(advanced imaging qualification program—NCI-designated Cancer Centers only)

• ECOG/ACRIN and ECOG membership


OEWG and ACRIN

C. Scanner qualifications

• CQIE (CT, MR, PET)

• ACRIN will be working with sites to qualify imaging scanners using CQIE standards


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


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?


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


After Trial Activation

TRIAL ACTIVATES!


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?

During Early Trial Development


Trial assigned to a representative from the RA Committee

RA Committee reps instrumental in forms development,which will have greater impact going forward …

RA Committee Rep’s Role


Every RA has a role in trial development:• Translation to local implementation• Reasonable timelines for procedures• Identifying pitfalls

(obstacles to studycompliance)

And let us know at any time when you see areas for improvement

Development and Implementation

mheckel

Reasonable expectations with clinical workloadSchedulingOther trials--recruitment barrier?RAs = Foot SoldiersPIs = GeneralsGenerals do not always know what is going on at front lines!


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)?

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

mheckel

EfficiencyTrial start-upEligibility flip charts and patient handouts ar eroutinely developed ... What protocol-specific tools can you think up?Who to contact ...



“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!


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



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.


“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!

Submitting to Local IRBs


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!

Thank You

mheckel

trial design to activation and ongoing recruitment and conduct of trial ...WE NEED YOU!


Questions?

annual meeting 2011 clinical trial development clinical trial development: oewg, ra’s role, and...

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