Clinical Trials Group

The MacDonald Clinical Trials Unit (MCTU) was established in 2002 to conduct industry-supported pharmaceutical drug and device trials in women's health and to support physician-initiated clinical research within the department. Since its inception, the MCTU has established a strong reputation as a regional leader in the conduct of pharmaceutical trials in women's health.

The Research staff in the MCTU offers investigators the support they need to conduct clinical research. MCTU staff are uniquely trained to carry out research protocols with an emphasis on patient safety and research quality.

Obstetrics and Gynecology Research

Obstetrics and gynecology (OB/GYN) clinicians representing all subspecialties conduct research both at the UH Landerbrook Health Center outpatient facility and at UH MacDonald Women's Hospital. We have recently expanded our efforts to include UH Ahuja Medical Center and the UH Westlake Health Center.

The MCTU at UH MacDonald Women's Hospital is staffed by highly qualified and experienced clinical research coordinators. The Nursing Core consists of a full-time certified research registered nurse and a full-time research assistant. The research staff is responsible for all aspects of ongoing clinical research projects including protocol planning, implementation and documentation of study activities.

Each clinical trial is assigned to a research nurse or coordinator. Working with the principal investigator (PI), the research nurse or coordinator collaborates with the PIs and co-investigators to identify subjects who may be willing to participate. The study staff reviews patient eligibility, educates the patients about clinical trial risks and benefits, and conducts study assessments and follow-ups. The research staff are closely involved with patients, monitoring their progress throughout the clinical trial and ensuring that patients’ safety, rights and privacy remain protected

Dedicated Clinical Trials for Pharmaceutical Research

The Director of the MCTU is Dr. James Liu, Chair of the department. Dr. Liu has extensive experience in pharmaceutical-oriented research trials having conducted more than 70 trials, including:

• Estrogen gels
• Hot flush
• Low-dose, third-generation progestin oral contraceptives
• Progestin-only contraceptives
• SERM
• SPARMs
• The effects of GnRH agonist on endometriosis
• The use of erythropoietin in uterine myoma and hysterectomy
• Trials of contraceptive steroid rings
• Use of the cervical cap

The OB/GYN department has experience conducting research trials for the following conditions:

• Fibroids
• Endometriosis
• Heavy Menstrual Bleeding
• Menopause
• Female Sexual Health
• Contraception

To learn more about current obstetrics, gynecology and reproductive biology research, contact 216-350-3075, email mctu@uhhospitals.org, or visit our patient research section.