Image of two researchers working in a lab

Clinical Research Center – CRC

The Clinical Research Center (CRC) at the C.S. Mott Center for Human Growth and Development brings together basic and translational research in order to improve the quality of life for our communities. Our cutting-edge medical research is conducted by highly-skilled medical investigators and support staff with unparalleled clinical expertise. We strive to treat our patients with the highest level of compassionate care while providing world-class research services to the investigators and sponsors we support.

“The Clinical Research Center is long-tested, and has experience in providing the physical environment, infrastructure, and service to support in the implementation of basic and translational research to advance therapeutic progress” Jack D. Sobel,M.D.,Director of Clinical Research Center, Distinguished Professor of Medicine and Dean Emeitus of Wayne State University School of Medicine.

Illustration for the Clinical Research Center with three focus areas: Pregnancy, Women's Health and Infertility

The Clinical Research Center is long-tested, and has experience in providing the physical environment, infrastructure, and service to support the implementation of basic and translational research to advance therapeutic progress.”

Jack D. Sobel, M.D.
Director of Clinical Research Center, Distinguished Professor of Medicine and Dean Emeritus of Wayne State University School of Medicine

History and Capabilities

Since 1995, the Clinical Research Center (CRC) has provided the infrastructure for a vast range of research— from smaller investigator-initiated trials, to larger pharmaceutical company trials, and expansive NIH-funded trials. Our research team has conducted more than 140 clinical trials in such therapeutic areas as uterine fibroids, endometriosis, Polycystic Ovarian Syndrome, adhesions, unexplained infertility, environmental contaminants on male factor infertility, sexual dysfunction (arousal and desire disorder), hot flashes and more. Over the past 4 years, we have expanded our areas of service to include the Department(s) of Dermatology, Internal Medicine, Pharmacy, and Nursing.

The CRC is thoroughly equipped for these research efforts, featuring:

  • Seven exam rooms, two with gynecological exam tables

  • Pharmacy for study drug storage

  • Laboratory for sample preparation, storage, and shipment

  • Conference room

  • Space for onsite monitoring

Image of examination room

Research services provided:

  • Regulatory submissions (WSU IRB, Advarra, WCG, DMC, and SMART IRBs)
  • Budget negotiations/CTA review
  • Creation of Source documents
  • Study Drug Pharmacy management
  • Coordinator Support
  • Dual-Energy X-ray Absorptiometry (DEXA) for bone scans
  • Vaginal plethysmography and genitosensory analyzer
  • Ultrasound (including vaginal US)
  • Electrocardiograms (ECGs) for recording the heart’s electrical signal
  • Phlebotomy capabilities that include storing, processing and shipping of blood and urine samples
  • Tissue Bank Repository to increase collaboration with local research centers

Our team assists with regulatory components of clinical trials through OnCore®, a Clinical Trial Management System (CTMS) which helps to streamline and centralize operations. The software is utilized university-wide to support all aspects of clinical trials, as it has the capacity to manage multi-site trials both nationally and internationally.

Translational Research

The CRC is structured as part of the C.S. Mott Center for Human Growth and Development so that partners receive the best of both clinical (directly patient-oriented) and basic (laboratory-focused) research. CRC clinician researchers work directly with patients, and many of their research interests focus on preventive measures and improved treatments. The basic science researchers of the CRC and C.S. Mott Center hold faculty appointments within the Wayne State University School of Medicine, and many of their laboratories focus on novel treatments and techniques. Their proximity creates an excellent environment for collaboration, granting researchers the unique opportunity to add a human dimension to their work. Together, clinical and laboratory researchers establish a dialogue, debate issues and challenge each other to develop new research skills that directly affect patient outcomes.

Your Impact

To promote health on a local and global scale, the CRC at the C.S. Mott Center focuses on advancing translational reproductive research, disseminating medical knowledge, and engaging in service and advocacy in a highly cost effective, compliant and efficient manner. Your partnership can strengthen our research outcomes by providing our faculty and staff with the resources necessary to push the boundaries of medicine, leading to life-changing breakthroughs. With your help, we can ensure that patients receive ground-breaking treatments through exceptional clinical care.

Clinical Research Center Team

Profile picture of Jack D. Sobel

Jack D. Sobel

Karen Priest (Collins)

Karen Priest (Collins)

Mindy Lindeman

Mindy Lindeman

Michelle Brossoit

Michelle Brossoit

Laura Cedo

Laura Cedo

Elizabeth Paton

Elizabeth Paton

Biljana Basic-Panic

Biljana Basic-Panic

Yanni Zhuang

Yanni Zhuang

Current studies

Ongoing clinical trials

A Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of Tildacerfont in Adult Subjects with Polycystic Ovary Syndrome (PCOS) and Elevated Adrenal Androgens

PI: Awoniyi Awonuga, MD
Sponsor: SPRUCE
Status: Recruiting

A Phase 3 Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women with Uterine Fibroids or Endometriosis who are at Risk for Pregnancy

PI: Jay Berman, MD
Sponsor: Myovant
Status: Recruiting

A Multicenter, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants with Moderately to Severely Active Systemic Lupus Erythematosu

PI: Housam Sarakb, MD
Sponsor: UCB Biopharma SRL
Status: Recruiting

A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Endometriosis and Associated Moderate to Severe Pain

PI: Jay Berman, MD
Sponsor: Abbvie
Status: Recruiting

A PHASE II, OBSERVER-BLIND, RANDOMIZED, CONTROLLED, STUDY TO EVALUATE IMMUNOGENICITY AND SAFETY OF A CANDIDATE VARICELLA VACCINE COMPARED WITH VARIVAX, AS A FIRST DOSE, ADMINISTERED IN HEALTHY CHILDREN IN THEIR SECOND YEAR OF LIFE

PI: Paul Kilgore, MD
Sponsor: GlaxosmithKline
Status: Pending recruitment start-up

Trajectory Patterns and Factors predicting Fatigue in Individuals on Hemodialysis

PI: Bincy Joshwa, PhD, MSN, RN
Sponsor: BCBSM, Ada Jacox Pain and Symptom Management Internal Research Award, College of Nursing start-up funds
Status: Pending recruitment start-up

A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain (M14-702)

PI: Awoniyi Awonuga, MD
Sponsor: Abbvie
Status: Active follow-up phase

A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women (M16-283)

PI: Awoniyi Awonuga, MD
Sponsor: Abbvie
Status: Active follow-up phase

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY

PI: Bernard Gonik, MD
Sponsor: Pfizer
Status: Active follow-up phase

A Phase III, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV Maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age

PI: Bernard Gonik, MD
Sponsor: GlaxosmithKline
Status: Active follow-up phase

A study of the long -term effects of aspirin and other factors on the health of older persons

PI: Shaun Cardoza, MD
Sponsor: Pfizer
Status: Active follow-up phase

Chronic Renal insufficiency Cohort – CRIC 2018 (CRIC IV)CRIC

PI: James Sondheimer, MD
Sponsor: NIDDK/UoM
Status: Active follow-up phase

Duke CRI and Bodyport Inc – Scale Study

PI: Luis Afonso, MD
Sponsor: Duke
Status: Active follow-up phase