Workshops and Coursework

Scholars are expected to complete coursework to advance their professional development and, according to NIH guidelines, they must also complete instruction related to responsible conduct of research, and training on rigor and reproducibility. The training may be tailored to the scholar’s experience and research project. The University of Pittsburgh’s Clinical and Translational Science Institute (CTSI) and Office of Academic Career Development (OACD) provide free workshops on a broad range of topics that fulfill this requirement; tuition-based courses are available via the Institute for Clinical Research Education (ICRE, see recent offerings below). Scholars are strongly recommended to pursue academic coursework that expands their scientific and research knowledge. Tuition and course materials may be charged to WRHR. As University faculty, scholars qualify for 10% tuition rate at Pitt.

Professional development and laboratory management
Pitt offers several programs to support junior faculty in their professional development and transition to independence. Here we highlight key opportunities that will bolster our scholars’ long-term success:

• Office of Academic Career Development (OACD): The OACD offers a variety of professional development workshops throughout the year, including the Mentored Career Development Award Series, providing guidance on competitive grant applications and workshops focused on career development. The OACD also provides a year-long orientation program, Springboard, for new faculty investigators in the Schools of the Health Sciences, provides guidance on research-related resources at Pitt and beyond and introduces key members of the research and administrative communities. Programs designed specifically for female scholars include the Women in Medicine and Science series. Upon request, the OACD also provides customized services, such as one-on-one coaching and referral assistance.
• Health Sciences Faculty Leadership Academy: This OACD year-long professional development program for early-career faculty members is designed to cultivate a generation of transformative academic leaders through shared leadership training. Participants complete nine workshops (2 full-day, 7 half-day) focused on developing a leadership style, supporting diversity, and building teams, creating a culture of respect though mentoring, overcoming difficult situations, and negotiating for success. This is a competitive program and requires nomination by the Department Chair reflecting a strong commitment to the applicant’s career and support for the applicant to attend the entire program. Dr. Edwards, OBGYN Chair and WRHR PI will nominate WRHR scholars and dedicate departmental funds to cover the program fee.

Design, execution and analysis of clinical trials
As noted in the above table, there are several recommended courses focusing specifically on training for clinical trials, including the CTSI’s courses “Fundamentals of Clinical Trials,” “Statistical Methods and Issues in Clinical Trials,” and “Special Topics in Clinical Trials” and the School of Public Health’s offerings “Clinical Trials: Methods and Practice” and “Design and Conduct of Clinical Trials.” Further, the NIH Office of Disease Prevention developed a free seven-part online course that provides a detailed guide to designing and analyzing group-randomized trials and includes video presentations, slide sets, suggested reading materials, and guided activities. Scholars engaging in clinical trials will be expected to take key courses and modules from among these offerings.

In addition to the training modules, our scholars can work with research mentors who are experienced in clinical trials, and they will also be able to participate in interactive presentations from the research faculty on this topic. Several of our OBGYN primary mentors are engaged in clinical trials and can ensure that scholars learn about registering trials at clinicaltrials.gov, preparing protocols, writing a RCT protocol paper, overseeing the contents and organization of a regulatory binder, and describing planned analyses. There are also excellent CTSI resources to support clinical trials, including the recruitment and staffing of a data safety and monitoring board. Further, Dr. Janet Catov, WRHR RD, has two current clinical trials enrolling women during and after pregnancy and can provide firsthand advice and guidance to scholars interested in clinical trials.

Data science track
This is an area of tremendous growth, and WRHR scholars will be encouraged to pursue training in this area. As part of the Pitt ICRE Master of Science in Clinical Research, scholars can select a Data Science track or choose individual courses in this track. Using data science to discover and insightfully forecast patterns from big biomedical data is at the core of modern medical research in managing patients’ health conditions, establishing novel treatment options, and building analytical intelligence. The courses offered by the ICRE Data Science Track are designed to build essential skills in data science for clinical research that include managing, analyzing, visualizing, and extracting meaningful information from very large healthcare data. WRHR scholars will have access to MOMI data (births from 1995) that is able to be linked via an honest broker to pediatric records and maternal health records across the life span. Trainees have utilized these approaches to study lifespan features of pregnancy complications, such as linking births complicated by a hypertensive disorder of pregnancy to a first myocardial infarction in women under age 65.

Training in sex as a biological variable
The incorporation of sex or gender as biological variables is reviewed in mentor-mentee sessions and in discussions at our WRHR Advisory Committee meetings. All scholars will complete the four modules of ORWH’s course “Sex as a Biological Variable: A Primer.” Other recommended Pitt courses and classes are offered under the Gender Health program and include Gender and Science; Gender and Medicine; Gender and the Child; and Gender, Trauma and Disability. Based on the research need, we will refer our scholars to the Mayo Clinic SABV course FunCaTS (fundamentals) and EcaTS (essentials).

Training in the responsible conduct of research (RCR)
During the first year, all scholars will enroll in the Pitt CTSI Training in the Responsible Conduct of Research Workshop Series, which includes Responsible Conduct of Research Principles and Application and at least three other workshops. These workshops, which are offered on a rotating basis throughout the year, are 1 hour in length and comprise lectures and case study-centered workshops. All scholars will complete additional required workshops (Making the Most of Mentoring, Faculty Leadership Academy, see above) in the second year. They will be expected to add additional training, determined based on elective RCR components, during their training.