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Report onNCIExtramural Cancer Epidemiology CohortStudiesJulie R. Palmer, ScD and Leslie L. Robison, PhD for theAdHocWorking Group on Strategic Approaches and OpportunitiesinPopulation Science, Epidemiology, and Disparities
Meetingof theAd HocSubcommittee on Population Science, Epidemiology, and DisparitiesNATIONAL CANCER ADVISORY BOARDJune 9,2019
Working Group Members
Lucile L. Adams-Campbell, PhD Georgetown UniversityChristine Ambrosone, PhD Roswell Park Cancer InstituteJudy E. Garber, MD, MPH Harvard UniversityMaria Elena Martinez, PhD University of California San DiegoJulie R. Palmer, ScD Boston UniversityElectra D. Paskett, PhD Ohio State UniversityBruce D.Rapkin, PhD Albert Einstein College of MedicineLeslie L. Robison, PhD St. Jude Children’s Research HospitalMargaret R. Spitz, MD, MPH Baylor College of MedicineKate Yeager, PhD, RN Emory UniversityDeborah M. Winn, PhD National Cancer Institute
InitialCharge to the Working Group from Dr.Sharpless
Assist the Subcommittee by engaging in discussions and developing recommendations on four focus points:Near-term concerns and long-term goals for existing and future cohort studiesBetter use of cooperative groups to address disparitiesSurvivors and cancer survivorshipExtramural training programs for scientists in population sciences, epidemiology, and disparitiesDr.Sharplesssuggested beginning with the first two focus pointsCharge given to the Working Group at first telephone meeting, June 19, 2018
Sharpless- Charge to Working Grp.
Invitations to Working Grp.
May June July Aug Sept Oct Nov Dec Jan Feb Mar Apr May June
2018
2019
Timeline of Working Group Activities
Sharpless- Charge to Working Grp.
Invitations to Working Grp.
May June July Aug Sept Oct Nov Dec Jan Feb Mar Apr May June
2018
2019
Timeline of Working Group Activities
Initial phone callsClarification ofscopeof thechargeNarrowed to a focus on cohort studies:“near-term concerns and long-term goalsof existing and future cohorts”Defining the keyquestions under that themeDeveloping a process foraddressingthe questions and coming up with a reportInformation gathering
Sharpless- Charge to Working Grp.
Invitations to Working Grp.
All of USCOHORT
NCI COHORT EVAL. PROJECT
DCEG CONNECT COHORT
VIRTUAL POOLED REGISTRY
SEER
May June July Aug Sept Oct Nov Dec Jan Feb Mar Apr May June
2018
2019
Timeline of Working Group Activities
NCI Current Portfolio
N=19
N=10
Cumulative Number of Funded Cohorts
Year Cohort Initially Funded by NCI
1976 1985 1995 2005 2015 2019
Preparations for 2-day meeting at NCI in JanuaryAssign 1-2 WG members to each questionSubgroup phone callsPrepare slide set for each question (N=6)
Sharpless- Charge to Working Grp.
Invitations to Working Grp.
Meeting of Working Grp.
Working Grp. Report
All of USCOHORT
NCI COHORT EVAL. PROJECT
DCEG CONNECT COHORT
VIRTUAL POOLED REGISTRY
SEER
May June July Aug Sept Oct Nov Dec Jan Feb Mar Apr May June
2018
2019
Timeline of Working Group Activities
Question 1. The role of cohort studies in etiologic and survivorship research in human populationsHow can NCI ensure that its cancer epidemiology cohort portfolio has the potential to address future questions related to cancer risk, cancer recurrence, cancer survival, and cancer-related long-term health outcomes?
Question 1. The role of cohort studies in etiologic and survivorship research in human populationsHow can NCI ensure that its cancer epidemiology cohort portfolio has the potential to address future questions related to cancer risk, cancer recurrence, cancer survival, and cancer-related long-term health outcomes?
Question 2. Utility of cohorts for addressing cancer health disparitiesWhat is the best way to ensure that the portfolio includes cohorts with large numbers of one or more populations that have been understudied and underserved?
Question 3. Study design considerations for extramural cancer epidemiology risk and survivor cohortsWhat are the optimal study designs to address cancer risk, recurrence, survival, and long-term health-related outcomes following cancer in human populations?
Question 4. Data sharing and collaborationHow can NCI ensure that the extramural scientists responsible for designing, organizing, and maintaining the cancer epidemiology cohorts remain motivated to continue these time-consuming efforts in this era of rapid sharing of data?
Question 5. Funding models for cohortsIs the funding mechanism to support cancer epidemiology cohorts optimal? If not, what other models might be better?
Working Group Report
Executive SummaryOverview of observationalcohorts in the NCI Extramural PortfolioFive specific questionsBackgroundWorking GroupassessmentRecommendations
Selected Recommendations and Opportunities for Enhancement
Q1. The role of cohort studies in etiologic and survivorship research in humanpopulations
….there are circumstanceswhere a cohort design reflects the most scientifically rigorousapproach….. toinvestigate important existing and emerging topics relating to cancer risk and outcomes.Thus, NCI should invest in providing sufficient infrastructure support for cohortsto…. addresscritical scientific gaps,anticipatethe scientific questions of the future, andconsiderssocietal issues that are deemed to be of high importance with high impact.
Selected Recommendations and Opportunities for Enhancement
Q1. The role of cohort studies in etiologic and survivorship research in humanpopulations
…. continue to support new and existing focused cohort studies to address specific cancer etiology and survivorship questions……. promote andfacilitate the use of existing and planned intramural cohorts inorderto leverage access of these resources for the broader extramuralcommunity….…. support establishment/expansion of national infrastructure for ascertainment and follow-up of cancer cases….
Selected Recommendations and Opportunities for Enhancement
Q1. The role of cohort studies in etiologic and survivorship research in humanpopulations
…. use of prevention and cancer therapy trials to address etiological research…. newsurvivor cohorts, opportunities to leverage the patient populations available through the NCI-supported cooperative clinical trials groups and theNCORP….. supportthe conduct of pilot studies to determine the feasibility and design for establishing an adult survivor cohort to investigate treatment-related adverseoutcomes….…. opportunities to draw upon the strengths/attributes of cohorts to conduct intervention research….
Selected Recommendations and Opportunities for Enhancement
Q2. Utility of cohorts for addressing cancer health disparities
…. additional cohorts are required to fill existing and future gaps in the NCI cohort portfolio…. on underrepresented populations…. insufficient numbers across the portfolio to allow meaningful within-group comparisons.…. support additionalbiospecimencollection in existing cohorts that have an appreciable number of participants from a single underrepresented group to address scientifically important questions.
Selected Recommendations and Opportunities for Enhancement
Q3. Study design considerations forcancerepidemiology risksurvivor cohorts
…. identify possible opportunities for embedding cohorts in interventions trials for primary prevention, screening and treatment ….…. whenscientificallyjustified, incorporation of serial data andbiospecimencollection over time to capture time-dependent events...…. support and facilitate methodological research to identify efficient and effective approaches for longitudinal specimen and data collection.
Selected Recommendations and Opportunities for Enhancement
Q4. Data sharing andcollaboration
…. Guidelines and/or mandates for data sharing of cohort-based data must take into consideration the investment of time and academic implications for investigators establishing and maintaining the cohort….…. The investigator and staff time/effort associated with data sharing/collaborative efforts… ongoing funding for data sharing will be needed… supplements have not been an appropriate funding approach because of the limited timeline for activities.
Selected Recommendations and Opportunities for Enhancement
Q4. Data sharing andcollaboration
…. for existing cohorts… informed consents may not allow some types of data sharing… may not always be feasible to re-consent participants……. new cohorts should consent for broad data sharing as part of the initial enrollment procedure.
Selected Recommendations and Opportunities for Enhancement
Q5. Funding models for cohorts
…. NCI should continue to use a Cohort Infrastructure Program Announcement for funding of infrastructure… Investigator-initiated hypothesis-driven research based on cohorts should be funded through R grants, P01s and related mechanisms.…. It may be most effective for NCI to accept applications for new cohorts only in response to a call for applications, which would occur periodically as needed… applications for new cohorts should be considered in a special study section, separate from reviews of continuations of cohort.
Selected Recommendations and Opportunities for Enhancement
Q5. Funding models for cohorts
…. Decisions about when to stop funding active follow-up of a given cohort should be based upon peer-review and the likely future productivity and importance of future findings…
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