Penn State Clinical and Translational Science Institute’s clinical research support includes a detailed guidebook for conducting clinical research at Penn State College of Medicine, recruitment tools, fully staffed clinical research centers in Hershey and State College, operational resources through Trial Innovation Network and more.
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Clinical Research Resources
What is Trial Innovation Network?
Trial Innovation Network is a collaborative initiative of National Center for Advancing Translational Sciences (NCATS) that seeks to address critical roadblocks in clinical trials and accelerate the translation of novel research into clinical practice.
Through its Clinical and Translational Science Award (CTSA) program grant, Penn State has become a member of the Trial Innovation Network, which provides study investigators with a broad range of services and consultations to optimize clinical trials and studies.
These services and consultations are designed to help investigators develop proposals into protocols, optimize study operations and enhance recruitment and enrollment. Trial Innovation Network is a rapidly developing and evolving collaborative initiative that leverages the expertise, skills and knowledge of the entire CTSA Consortium.
What services are offered through Trial Innovation Network?
Individual services available include study budget, projected timelines, recruitment and retention plan and materials, initiating a central IRB, study feasibility assessment, standard agreements, community engagement, and electronic health record cohort assessment. A liaison team reviews multi-site project proposals and determines what projects should be submitted to the Trial Innovation Network for further review and consideration.
Who can submit a proposal to Trial Innovation Network?
All full-time faculty at Penn State can submit.
How should proposals be submitted?
Investigators must contact their local Trial Innovation Liaison Team to discuss their proposal and obtain a brief consultation prior to submission. A consultation with the local Trial Innovation Liaison Team is important because these teams will directly connect the local hubs to the national network and provide advice and input on proposals.
Proposals submitted to Trial Innovation Network should have a strong scientific hypothesis and should be responsive to each section of the Proposal Intake Form. Detailed information on the proposal form can be found here.
Full-time faculty with questions about the Trial Innovation Network, or who are interested in submitting a proposal, should request support.:
Clinical research guidebooks are available for faculty and staff members engaged in clinical research.
These resources, adapted from materials created by The Clinical Trials Resource Group at University of California-Davis CTSC, include sections on several aspects of the research process, including resources and training, study development and feasibility, financial consideration, compliance and protected health information.
A separate version is available for Penn State College of Medicine.
Penn State has two Clinical Research Centers (CRCs) that provide research infrastructure including study nurses for investigators who conduct research with human subjects.
Clinical Research Centers are located in Hershey and University Park.
The Division of Population Health Research and Development, located within the Department of Medicine at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine, seeks to increase research funding for investigator-initiated clinical trials by providing hands-on mentorship/guidance along with an individual to write the proposal and an individual to submit the grant.
This process limits the efforts required for investigator-initiated clinical trials, allowing the team to become specialized, creating efficiencies and expertise while increasing the number of grants submitted.
Interested individuals should contact Christopher Sciamanna, MD, MPH, Professor of Medicine and Chief, Division of Population Health Research and Development, at firstname.lastname@example.org.
StudyFinder is a web-based recruitment tool for Penn State researchers, managed and sponsored by Penn State Clinical Translational Science Institute. It is available to all Penn State researchers actively recruiting participants or volunteers for studies.
StudyFinder displays data in a way that is intuitive and user-friendly for the public. Only those studies that have indicated in CATS IRB that they wish to use StudyFinder as a recruitment tool are included on the StudyFinder website
Information is updated once per day upon receipt of IRB approval and is retrieved from the CATS IRB smartform StudyFinder Recruitment page. If clinical trials registration is required for the study, further information will be gathered using the NCT number and pulled from ClinicalTrials.gov.
Study information provided in CATS IRB must be presented in lay language to be most effective in reaching potential participants. Periodic review of study information in CATS IRB is encouraged to help potential participants connect with available research.
Clinical Trials Office
The Clinical Trials Office, located at the College of Medicine and Milton S. Hershey Medical Center, enhances, fosters and promotes organized, high-quality clinical research.
Institutional Review Board/Human Subjects Protection Office (IRB/HSPO)
The Institutional Review Board at Penn State consists of independent committees established to protect the rights and welfare of human subjects involved in research at the University.
The Human Subjects Protection Office administers the institutional program to protect research subjects, provides administrative support to the IRB and assists faculty/staff with the requirements to meet ethical and regulatory standards for human research.
Multiphase Optimization Strategy (MOST)
Researchers at Penn State Methodology Center are developing the multiphase optimization strategy to provide a framework for engineering efficacious and effective behavioral interventions.
Conceptually rooted in engineering, MOST emphasizes efficiency and careful management of resources to move intervention science forward systematically.
MOST can be used to guide the evaluation of research evidence, develop optimized interventions and enhance Type I and Type II translational research.
Special Populations Liaisons
Penn State Clinical and Translational Science Institute, working with subject-matter experts across the institution and throughout the community, provides researchers with access to special populations, mentors junior faculty and provides consultation lifespan research.
Areas of expertise include:
- childhood overweight/obesity
- childhood trauma
- women’s prenatal health
- aging populations
- military service members
- veterans and their children/families
- rural populations
- unique patient populations, including nicotine addiction, infertility, ALS, cystic fibrosis, sleep disorders and end- of-life care