Richard Platt was recently awarded a 26-month contract with Pfizer Inc. to conduct a study titled, A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States. This is Phase 2 of a multi-phased project. The goal of this phase is to monitor the uptake of Pfizer-BioNTech COVID-19 vaccine, to characterize vaccine recipients and rates of selected outcomes, and to prepare for Phase 3, involving the execution of the Study Protocol.
Health Data Collaborations for Safety and Effectiveness Research (HDC-SER) within The Division of Therapeutics Research and Infectious Disease Epidemiology (TIDE) was recently awarded an 17 month contract with GlaxoSmithKline (GSK) to develop the protocol and statistical analysis plan for a cohort study titled, Effectiveness and safety of recombinant zoster vaccine (RZV) in adult solid organ transplant (SOT) recipients. The goal of this study is touse electronic healthcare data complemented with medical record review from participating Sentinel Data Partners to rigorously evaluate the real-world effectiveness and safety of recombinant zoster vaccine (RZV) in adult SOT recipients. A group of health plans with claims data linked to EHR data will be used to assess clinical information and uptake of RZV to further characterize the cohorts of interest.
TIDE is hiring! Chief Data Scientist and Lead Biomedical Informatician, FDA Sentinel Operations Center - Assistant or Associate Professor
The Department of Population Medicine (DPM) at the Harvard Pilgrim Health Care Institute, a Harvard Medical School affiliate, seeks a faculty member to lead the data science and biomedical informatics work of its Division of Therapeutics Research and Infectious Disease Epidemiology (TIDE). The proposed academic appointment will be as Assistant / Associate Professor of Population Medicine at Harvard Medical School, commensurate with qualifications. Please click here for the full position description. Responsibilities include leading strategic planning and implementation of system architecture, data models, ontologies, and querying strategies. Candidates should send their CV, cover letter, and a statement of research interests to: Darren Toh, ScD, Professor, Department of Population Medicine c/o TIDEFacultysearch@harvardpilgrim.org.
The Division of Therapeutics Research and Infectious Disease Epidemiology was recently awarded an 18 month contract with GlaxoSmithKline (GSK) titled, Safety and effectiveness of recombinant zoster vaccine in adults with systemic lupus erythematosus (SLE) or multiple sclerosis (MS). The goal of this study is touse electronic healthcare data complemented with medical record review from participating Sentinel Data Partners to rigorously evaluate the safety and real-world effectiveness of recombinant zoster vaccine (RZV) in patients ≥18 years with systemic lupus erythematosus (SLE) or multiple sclerosis (MS). This phase 1a study will lay the groundwork with the development of a protocol and statistical analysis plan. A group of health plans with claims data linked to EHR data will be used to assess clinical information and uptake of RZV to further characterize the cohorts of interest.
Dr. Jeffrey Brown was recently awarded a 15-month contract with GlaxoSmithKline (GSK) titled, Shingrix Pregnancy Exposure Study, Epi-Zoster 039 (Phase 1b). GSK received approval for the expanded indication for the recombinant zoster vaccine, Shingrix. The expansion will include persons 18 and 50 years of age who are immune compromised (IC) or immunodeficient due to disease or medications in the United States, for whom there is a high unmet medical need for prevention of herpes zoster.
As it is difficult to anticipate the number of women with IC who will be exposed to Shingrix during pregnancy, GSK will evaluate the feasibility of conducting a pregnancy exposure study by monitoring Shingrix exposure in pregnant women with IC in the distributed research network. HPHCI has worked with GSK to complete prior preparatory phases, leading up to this current Phase 1b. This project phase will include the development of the full study protocol.
Richard Platt and Xiaojuan Li are awardees of the IMPACT Demonstration Projects Program, a new funding mechanism to support full-scale, Stage IV effectiveness ePCTs testing non-pharmacological interventions for people living with Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) and their care partners that are linked to the needs of a health care system. Recipients were selected from an impressive group of competitive applications.
In this new project, Harvard Pilgrim Health Care Institute (HPHCI) will conduct a pragmatic randomized clinical trial to evaluate a collaborative care coordination program embedded in a health plan for persons living with ADRD and their caregivers.
The program consists of comprehensive needs assessments, creation and implementation of personalized care plans, monitoring and revising care plans, disease education and support coaching, referrals to community-based organizations for service and support, and access to assistance. The trial will be embedded in the legacy Tufts Health Plan (THP), where the program is currently available to patients with advanced ADRD. The trial will expand the program to those with early or moderate ADRD.
Title: Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)
Co-PIs: Richard Platt, Xiaojuan Li
Funder: Brown University via The National Institute on Aging (NIA)
The Reagan Udall Foundation (RUF) recently awarded the Harvard Pilgrim Health Care Institute Department of Population Medicine (HPHCI PI: J Brown) a contract to continue implementation of a study titled: Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycemic agents (AHA) (EU PAS Register number: EUPAS31378). The goal of the study is to compare the risk of diabetic ketoacidosis (DKA) with use of ertugliflozin compared to the risk of DKA in other antihyperglycemic agents.
The research activities will be a collaborative effort between Merck, the Innovation in Medical Evidence Development and Surveillance (IMEDS) Operations Center at RUF, the IMEDS Analytic Center at HPHCI, and participating IMEDS Network Partners.
The Reagan Udall Foundation (RUF) recently awarded the Harvard Pilgrim Health Care Institute Department of Population Medicine (HPHCI PI: Jeffrey Brown) a contract to conduct the final analyses for a study titled: Database cohort study to assess the risk of serious angioedema in association with LCZ696 (sacubitril/valsartan; Entresto) use in Black patients with heart failure in the United States. The study will use data sources from the Innovation in Medical Evidence Development and Surveillance (IMEDS) and the Center for Medicare and Medicaid (CMS). The goal of the study is to provide real-world estimates of the incidence of angioedema among HF patients initiating Entresto (sacubitril/valsartan) and HF patients initiating an ACE inhibitor, with a primary focus on Black patients. The research activities will be a collaborative effort between Novartis, the IMEDS Operations Center at RUF, the IMEDS Analytic Center at HPHCI, and participating IMEDS Network Partners.
Developing a Program to Educate Sensitize Caregivers to Reduce the Inappropriate prescription Burden In Elderly with Alzheimer's Disease study (D-PRESCRIBE-AD, NIA R61AG069794 ) is a pragmatic trial of a planned 22,500 individuals with Alzheimer's disease or related dementias in the community. It examines the effect of a provider and patient/caregiver-centered educational intervention on inappropriate prescribing, which includes the use of medications that may no longer be necessary or that may increase the risk of harm. PI: Jerry Gurwitz; HPHCI PI: Rich Platt. Funded on 9/30/2020, with potential for an additional 4 years of funding if approved for an R33 phase.
The Harvard Pilgrim Health Care Institute Department of Population Medicine (PI: Jeffrey Brown) was recently awarded a 22 month contract with GlaxoSmithKline to study the use of selected medications during pregnancy. This multi-site study uses health plan claims data and claims data linked to electronic health record data to identify and characterize women exposed to Nucala (mepolizumab) and Benlysta (belimumab) during pregnancy specifically, and more generally among women of child-bearing years. The project will also evaluate the potential of these data for conducting comparative studies between women who were exposed and women who were not exposed to these products during pregnancy.
Dr. Jeffrey Brown was awarded a three-month contract with GlaxoSmithKline (GSK) titled, Shingrix Pregnancy Exposure Study (Preparatory Activities) in June 2020. The goal of this contract is to provide GSK with recommendations for the design and conduct of their planned monitoring study.
Dr. Julia Marcus presented on March 6, 2019 at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019) in Seattle, WA. Her presentation titled "Using EHR Data to Identify Potential PrEP Candidates in a Large Health Care System" described a prediction model to identify patients at risk of HIV acquisition in Kaiser Permanente Northern California.