a new point of view: an “outsider’s” perspective from the inside of the nci and the ccop...

A New Point of View: An “Outsider’s” Perspective From the Inside of the NCI

and the CCOP Strategic Plan

Marge Good, RN, BSN, MPH, OCNMD Anderson Cancer Center Meeting

March 3, 2011

Objectives

• Background/History

• Current role

• Learning the NCI from the inside

• CCOP Strategic Plan overview & highlights

Background/History

• Began working in oncology 1983– Delivered chemotherapy– Ordered drugs– Phone triage nurse

• Hired as CCOP research nurse in 1988– Enrolled patients on clinical trials– Collected and submitted data

• Typed flow sheets ()– Began with 3 nurses, 2 office staff & Director

Background/History

• 1993 began role as Administrative Director– Reviewed newly activated trials for possible implementation– Prepared selected trials for IRB submission– Devised systems and processes for study implementation– Maintained communication between research bases and CCOP– Managed CCOP staff (25 nurses, CRAs)– Monitored accrual, data submission timeliness, queries, internal audit findings &

staff workload on monthly basis– Prepared and submitted NCI Progress Report & NIH/NCI CCOP U10 re-

competing grant applications– Communicated with PI and sub-investigators – Coordinated communication and training for satellite sites– Participated in fiscal agent oncology service line activities– Developed SOPs– Monitored budget

Background/History

• 28 years of oncology experience

• 22 years total with Wichita CCOP

• 17 years as Administrative Director – Wichita CCOP

Current Role

• Nurse Consultant – COPTRG/DCP/NCI– Collaborate and consult with CCOPs as a representative of the NCI

– Provide leadership, development and coordination for activities focusing on clinical trial management, accrual and outreach to minority populations

– Develop and/or assist in the development of clinical trial related position statements, public relations documents, guidelines and other materials

– Organize, coordinate and conduct meetings as well as serve on advisory, steering and planning committees and other groups to address clinical trials in community setting and related issues

– Lead efforts to increase accrual, address barriers and evaluate strategies

– Mentor new clinical trial sites and contribute to the evaluation of the community clinical trials program

Current Role

• Major role:– Bring community perspective to the NCI

• Years of experience– One CCOPs perspective

• No longer physically in the community• Not the expert for all CCOPs

– Each are different in their own ways

• Communication will be key

How Things Work: A View From the Inside

• It is the government!– Many layers

• Institutes, divisions, branches, groups• Each with goals, grant programs and funding

– Complex reporting structure– Security is tight!! – Still much to learn

A Visual Perspective

Department of Health & Human Services

National Institutes of Health - Institutes

Institute Name Acronym Year Establishe

d

National Cancer Institute NCI 1937National Institute of Dental & Craniofacial Research NIDCR 1948

National Heart, Lung & Blood Institute NHLBI 1948

National Institute of Mental Health NIMH 1949

National Institute of Diabetes & Digestive & Kidney Diseases NIDDK 1950

National Institute of Neurological Disorders & Stroke NINDS 1950

National Library of Medicine NLM 1956

National Institute of General Medical Sciences NIGMS 1962Eunice Kennedy Shriver National Institute of Child Health & Human Development NICHD 1962

National Eye Institute NEI 1968

National Institute of Environmental Health Sciences NIEHS 1969

National Institute on Alcohol Abuse & Alcoholism NIAAA 1970

National Institute on Drug Abuse NIDA 1973

National Institute on Aging NIA 1974

National Institute of Arthritis & Musculoskeletal & Skin Disorders NIAMS 1986

National Institute of Nursing Research NINR 1986

National Institute on Deafness & Other Communication Disorders NIDCD 1988

National Human Genome Research Institute NHGRI 1989

National Institute of Biomedical Imaging & Bioengineering NIBIB 2000

National Institute on Minority Health & Health Disparities NIMHD 2010

National Institutes of Health – Centers

Center Name AcronymClinical Center CCFogarty International Center FICNational Center for Complimentary & Alternative Medicine NCCAMNational Center for Research Resources NCRRCenter for Information Technology CITCenter for Scientific Review CSR

NIH Clinical CenterBethesda, Maryland

National Cancer Institute - Intramural

National Cancer Institute - Extramural

National Cancer Institute6130 Executive Blvd, Rockville, MD

National Cancer InstituteDivision of Cancer Treatment &

Diagnosis

National Cancer InstituteDCTD - CTEP

National Cancer Institute Division of Cancer Prevention

Entrance

COPTRG

CCOP Strategic Plan

• Established to explore issues needing to be addressed to ensure programs continue to successfully contribute to the NCI mission.

• In person meeting and conference calls

Strategic Goals

1. Incorporate emerging science & novel trial designs into cancer prevention/control research

2. Maximize community resources

3. Use epidemiological and biological data from underrepresented populations to address disparate clinical outcomes

4. Improve trial access and participation

5. Build on success of CCOP/MBCCOP to further improve the ability of community institutions to accrue to clinical trials.

1. Incorporate emerging science & novel trial designs into cancer prevention/control research

• Develop and enhance survivorship research

• Enhance research on acute treatment toxicities & cancer symptoms

• Foster research on risk assessment and risk modeling

• Develop funding mechanisms for correlative studies

• Foster relationships with basic science researchers

• Develop mechanisms to encourage training for young & mid-career cancer prevention & control investigators

2. Maximize community resources

• Develop supplemental funding for biospecimen collection• Develop new funding model to support true level of effort• Encourage standardization & improve efficiency across

Network• Develop process to address issues related to changing health

care environment• Provide support to professional organizations to develop

mentorship programs• Foster collaboration with NCI Office of Communication &

Education• Address partial overlap of activities with other NCI community

programs

3. Use epidemiological and biological data from underrepresented populations to address disparate clinical

outcomes

• Apply current & emerging science to identify & address research questions

• Develop trans-disciplinary working group to develop pilot studies

• Promote cancer risk assessment or individuals in underserved communities

4. Improve trial access and participation

• Consider broadening eligibility requirements for MBCCOPs

• Facilitate language translation

• Implement a plan for assigning credit for screening

• Develop recommendations/guidelines for publications

• Review accrual requirements for MBCCOPs

• Develop an effective model to incorporate patient navigation

• Increase diversity in the workforce

5. Build on success of CCOP/MBCCOP to further improve the ability of community institutions to

accrue to clinical trials

• Develop Best Practice Accrual Guidelines• Systematically collect & maximize use of data in

CCOP progress reports on patients screened• Develop process to rapidly indentify & address

slow accruing clinical trials• Encourage development of correlative studies

that address accrual

My Strategic Plan-Related Tasks

– CCOP 101 Manual– Accrual Best Practices Guidelines– Develop web-based training modules for CCOP staff– Improve the auditing process– Establish consistent means of communication

between CCOPs and NCI– To listen and help decrease barriers– Provide input for new funding structure– Other tasks as needed

Future of CCOP

• Strategic Plan development and past successes assured favorable review by BSA– Viewed as an important program by the NCI

Director– Provided approval for 3 years of funding

• Continued success and viability will be further ensured by implementation of strategic plan action items– Will require involvement of CCOP leaders (PIs,

Administrators, RBs & COPTRG)