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Clinical Methods Sub-core

The Methods Sub-Core provides comprehensive support and consultation on new pilot projects, led by Drs. Kyriakides (Clinical Trials, Laboratory Studies), Dr. Spiegelman (Observational Studies; Implementation Science), and Dr. Rios Motta (Health policy and Health Services Research), and supported by a cadre of Yale and UPR faculty with expertise in epidemiology or biostatistics related to HIV research.

The Department of Biostatistics and Yale Center for Analytical Sciences have been providing strong support to HIV researchers on an ongoing basis and will continue to do so for both Yale and UPR faculty; the Methods Sub-Core offers additional expertise and assistance for dedicated efforts. The process engages researchers from the beginning of the formulation of the pilot grant idea of a pilot through submission of the application for possible funding. A short, succinct and standardized research design clinic application document is made available through the Sub-Core to all interested researchers; this ensures all main components of the background, design and methodology of the proposed pilot project are provided in advance of the research design clinic to permit review for subsequent discussion.

In addition, an important function of the Methods Sub-Core is to provide continuity in support throughout all phases (from pilot projects through subsequent research projects) of a faculty member’s research involvement. Further, the Methods Sub-Core will be instrumental in developing new methodologies in HIV research that can be deployed as necessary to pilot and subsequent research projects. In partnership with other researchers and cores the Methods Sub-Core will work to develop new and enhance existing methodological approaches in HIV research. White papers and guidelines will also be developed to provide an additional resource for HIV investigators and UPR.

  • Assistant Professor of Biostatistics; Director, Cooperative Studies Program Coordinating Center (West Haven, CT), Department of Veterans Affairs

    Dr. Kyriakides collaborates with clinical researchers on numerous research projects and he provides statistical consulting on numerous research protocols. He has been an abstract mentor for young researchers at the International AIDS Conferences since 2012, leads the VACSPCC internship program and is a statistical reviewer for high-impact medical journals (Lancet Infectious Diseases and the Lancet Gastroenterology & Hepatology).He is the Director at the Department of Veterans' Affairs Cooperative Studies Program (VACSPCC-West Haven) and has worked, as a Senior Biostatistician, on pivotal clinical trials (The OPTIMA Trial, a multi-national HIV/AIDS treatment clinical trial; a surgical clinical trial (The OVER Trial); and a PTSD clinical trial (The VIP-STAR Trial). Even though his primary research focus is in the area of infectious diseases with particular emphasis on HIV/AIDS and its treatment, he has an interest in the history of medicine, social determinants of health and the socio-cultural dimension of the benefits of Greek/Mediterranean nutrition. He has recently been certified as an Olive Oil Sommelier by the International Culinary Center and the Olive Oil Education Lab in NY City. He is the co-proponent for the establishment of a Yale institute dedicated to the olive tree, its products and their impact on human and planetary health.
  • Ruth Ríos Motta, PhD (Methods Sub-Core Co-Director) is a graduate of UPR and John Hopkins (PhD in Health Services Research/Health Policy) whose biostatistical and health policy expertise has been applied to nutrition, cancer survival, use of alternative medicine, and ZIKA virus, among other topics that have synergy with challenges in the HIV field. She is a perfect complement to Drs. Kyriakides and Spiegelman in Methods co-leadership.
  • Susan Dwight Bliss Professor of Biostatistics; Affiliated Faculty, Yale Institute for Global Health; Director, Center for Methods in Implementation and Prevention Science (CMIPS); Director, Interdisciplinary Research Methods Core, Center for Interdisciplinary Research on AIDS; Assistant Cancer Center Director, Global Oncology, Yale Cancer Center

    Donna Spiegelman was appointed the Susan Dwight Bliss Professor of Biostatistics at the Yale School of Public Health in 2018. As one of the few people in the world with a joint doctorate in biostatistics and epidemiology, she can freely speak the languages of both disciplines and switch between these two professional cultures, playing the role of interlocutor for either. Her research is motivated by problems which arise in epidemiology and require biostatistical settlement. In particular, but by no means exclusively, she has focused on methods for study design and data analysis which reduce bias in estimation and inference due to measurement error or misclassification in the exposure variable. A particular current interest is risk-based monitoring of multi-center investigations to enhance quality and prevent fraud.She has extensive experience in troubleshooting and solving methodological issues that arise in longitudinal investigations, in clinical trials, and in large scale public health effectiveness evaluations. Before coming to Yale in 2018, Dr. Spiegelman played dynamic roles as professor, mentor, and expert statistician at the Harvard T.H. Chan School of Public Health for nearly 30 years. She was the recipient of the NIH Director’s Pioneer Award and recently the recipient of the Committee on the Advancement of Women Faculty Mentoring Award.