2011 ACRIN Annual Meeting ACRIN Accrual Committee ACRIN 2011 Fall Meeting Reginald F. Munden

2011 ACRIN Annual Meeting ACRIN Accrual Committee Reginald Munden, MD (Thoracic Committee) MDACC Hiroyuki Abe, MD (Breast Committee) - University of Chicago Peggy Anthony (Patient Advocacy Committee Chair) Lorna Beccaria (RA Executive Committee) Sanford Jeames (Patient Advocacy Committee) Suzanne Lenz (RA Executive Committee) - Darthmoth Barbara Galen (NCI Rep) Frank Lin (NCI Rep) Chaan Ng, MD (GYN Committee) - MDACC Rathan Subramaniam, MD (Head/Neck/Neuro Committee) – Boston University Betty Patterson, MD (Patient Advocacy / Special Populations Committee Chair) - Retired Tracy Petro (RA Executive Committee) - Springfield, IL Michael Yu, MD (Experimental Imaging Science Committee) - Fox Chase Nancy Fredericks - ACRIN

ACRIN Accrual Committee Goal: 1.To improve recruitment of institutions and investigators (site recruitment) into ACRIN clinical trials. 2.To improve participant enrollment (patient recruitment) into ACRIN clinical trials. Deliverables: Recommendations to improve participation by institutions and sites Methods/strategies to improve patient recruitment into clinical trials Data and information to incorporate into clinical trials to ensure recruitment

ACRIN Accrual Committee Site Recruitment – Site issues – Physician/Radiologists issues Patient Recruitment – Science/Protocol related – Patient Related – Referring physician related

Accrual Committee Site Recruitment – Site Issues Start Up Funding - Institutions require funds to cover costs of the trial prior to initiation. ACRIN reimbursement is typically not funded until patients are enrolled. Sites need to be capable of performing the patient enrollment process and imaging requirements, but they may not be familiar with the specific needs to accomplish the trial. Competing clinical trials limits resources. Lack of resources to conduct imaging trial (equipment, technologists, assistants).

Accrual Committee Site Recruitment – Physician Issues Site PI for ACRIN trial does not receive recognition for their efforts and time by Chair, Institution, or NCI. Lack of excitement by radiologist for ACRIN trial. Lack of knowledge regarding importance of ACRIN. Lack of understanding the time and resource commitment needed by PI. Lack of engagement by referring physicians.

Accrual Committee Patient Recruitment – Science/Protocol The complexity of imaging protocols – especially very ill patients Increased focus on biomarkers requires biopsies/molecular staining and pathology support Trials often demand single therapy to limit impact of imaging results, but institutions are typically ones offering multiple therapies Coordinating access to an imaging agent (FLT/FMISO) impacts activation Timing of imaging and scanner access has a significant impact on accrual Cost of imaging - often costs for imaging far exceed funding

Accrual Committee Patient Recruitment – Patient Related Potential participants, especially cancer patients, are overwhelmed with their diagnosis and not receptive to a study that delays treatment Imaging studies offer little to no directly obvious patient benefit Patients prefer to have scanning close to home. ACRIN study may require imaging that is only available at large medical center

Accrual Committee Patient Recruitment – Referring Physician Need buy in from referring physician Referring clinician perception of value of the imaging in the trial. Lack of coordination and awareness of studies within and between departments in a given institution. Time to introduce a clinical trial is challenging in a busy clinic setting.

ACRIN Accrual Committee Demonstration Projects Suzanne Palmer, MD/ Chan Ng - University of Southern California / MD Anderson Pamela Woodard, MD - Washington University Carol Mertens, PhD - University of Iowa David Mankoff, MD, PhD /Connie Lehman MD, PhD- University of Washington