Epidemiological consultation will range from small requests that range between 1-5 hours to complete to comprehensive projects that include all analyses for a manuscript. Examples of small requests include: a. Direction on what is the most appropriate test for statistical inference in a given study or dataset (e.g. t-test, ANOVA, linear regression, logistic regression, Cox-proportional hazards modeling, etc.), how to perform it R, SAS, STATA etc., and how to interpret the results. b. Sample size or power calculations for grant applications. c. Programming/ code review of analysis that has already been completed by the requester. Other examples of more extensive services offered include: d. Designing a retrospective cohort or case-control study within the MGB RPDR (Research Patient Data Registry) to investigate clinical epidemiological associations – based on EHR data from clinical diagnoses, laboratory results, medications, etc. e. Linkage of RPDR/ Biobank participants with state cancer registry or with death index to study cancer/ mortality outcomes. f. Extraction of genetic data from MGB Biobank genomic data to generate polygenic risk scores (of various diseases, phenotypes, traits, etc.) and conduction of genomic association studies or Mendelian randomization studies.

a. An investigator is preparing a grant to implement a prospective stool collection to be paired with other molecular endpoints collected in ongoing immunotherapy trials across DF/HCC. EPICORE is able to provide support for all phases of the project, including letters of support for the grant application. An initial consultation with the biorepository service can provide recommendations as to the best collection methods to empower downstream analyses, including available kits, proper fixatives, and immediate processing and long-term storage requirements. The epidemiologic study design consultation can provide insights as to how best design collections for endpoint analyses as well as considerations for statistical power. If funded and depending on investigator resources, EPICORE can assist in IRB protocol review to start the study, kit creation and materials sourcing for sample collection, sample processing, accessioning, and storage within the DOM biorepository. When collection has been completed, EPICORE technicians can assist with sample retrieval and shipment to academic or industry partners for analysis (i.e. metagenomic sequencing or metabolomics). EPICORE can similarly assist with downstream analysis of multiple -omic data sets via our bioinformatic support channels. Any or all of these services can be provided by EPICORE to meet individual needs. b. An investigator has an ongoing study characterizing microbial and immunologic changes in inflammatory bowel disease. The study requires collecting stool and blood samples to identify genetic and molecular characteristics associated with the progression of this disease. Depending on the PI’s resources, there are multiple ways they could utilize the CTEU EPICORE. First, if the PI did not have their own lab bench or fume hood, they could utilize the CTEU Biobank lab space to aliquot the stool and blood samples. Second, if the PI did not have dedicated study staff trained in sample processing, they could utilize the CTEU Biobank lab techs to complete the processing. Third, if the PI didn’t have access to a -80 freezer, they could store their sample aliquots in one of the CTEU Biobank’s -80 freezers. These services could be used in any combination necessary to meet the investigator’s needs.

The MGB Biobank serves as a central biobanking repository offered as a resource to all MGB investigators in need of patient samples or data for specific research projects. Patients are consented directly to the MGB Biobank and their data is available via an application process to any MGB investigator. The CTEU EPICORE is a fundamentally different service; rather than directly aggregating patient data, it will assist individual investigators in the planning, collection, processing, and/or storing of samples and data from specific patients or study participants for individual investigator-initiated projects. Since the CTEU EPICORE will operate under a broader MGB laboratory safety protocol for sample and data handling, patients will only need to be consented to the investigator’s study covering the use and collection of these samples. See FAQ #4 for more information on data sharing within the CTEU EPICORE.

Any investigator who uses the CTEU EPICORE will retain stewardship of their study’s samples and data. However, we will be maintaining a database of ongoing projects that can be searched by individual MGH investigators who may be interested in collaboration. Data and biospecimen sharing will occur on a study-by-study basis to be managed by individual collaborating investigators and will not be overseen by EPICORE. Investigators specifically seeking collaborations or those that are open to broadly sharing their resources within the DOM may opt-in to denote this interest in the database. EPICORE can assist in making samples or data accessible to collaborating investigators at the direction of the study’s PI.

Any DOM investigator wishing to understand the studies and investigators being supported by EPICORE may request access to our database listing investigator-initiated projects. Collaborations should be sought out and established with the study’s PI before engaging EPICORE.

While this service is intended to support DOM investigators, we may provide services on a case-by-case basis to non-DOM investigators. Please contact us to learn more.