What is a clinical trial?
A clinical trial is a health-related research study in human beings that follows a pre-defined protocol. Interventional studies aim to answer specific questions about new therapies or new ways of using known treatments, while observational studies are those in which patients are observed and their outcomes are measured by the investigators. Carefully conducted clinical trials are the safest and most efficient way to identify treatments that work in people.
There are several benefits to participating in a clinical trial. Participants have the opportunity to play an active role in their own health care, gain access to new investigational treatments before they are made widely available, and help others by contributing to the advancement of medical science through research.
The welfare of participants in clinical trials is carefully protected by the IRB (Institutional Review Board) and the Ethics Committee, each of which reviews all aspects of a clinical trial both before the investigator is able to enroll participants and throughout the trial.
For more information about clinical trials, please visit www.clinicaltrials.gov
Columbia University's Medical Center provides world-class leadership in scientific research, health and medical education, and patient care. Faculty members from its four schools (College of Physicians & Surgeons, College of Dental Medicine, School of Nursing, and Mailman School of Public Health) carry out the school's core mission of educating and training future generations of health care professionals. Research is conducted with the ultimate goal of translating discoveries into new techniques for fighting disease and improving health. Columbia University researchers are responsible for a number of significant clinical breakthroughs - among them, the first blood test for cancer, the first medical use of the laser, and the first successful transfer of genes from one cell to another.
The Clinical Research Unit (CRU) within the Department of Dermatology was established by Dr. David Bickers in the 1990s, and was directed by Dr. Franco Barsanti from 2002 to 2007. Under his leadership and with support from Dr. Bickers, the CRU has grown in size and developed into one of the nation’s most outstanding clinical research units in the field of dermatology. Our new director, Dr. Julian Mackay-Wiggan, aims to continue our trajectory of growth and increase our repertoire of studies.
The CRU is located adjacent to the Department of Dermatology’s medical clinics within the Herbert Irving Center for Dermatology and Skin Cancer on the twelfth floor of the Herbert Irving Pavilion. The research unit is a self-contained organization within the Department of Dermatology with access to outpatient and inpatient facilities of the NIH-funded Columbia University Irving Center for Clinical Research (ICCR). A fully-equipped medical photographic studio housed within the unit allows for high-quality, reproducible clinical photography. The CRU is equipped to conduct all phases (0-4) of clinical trials, and has been instrumental in the development of many dermatologic drugs used today.
In addition to conducting trials for the pharmaceutical industry, the unit has been engaged in numerous protocols supported by the NIH and other investigator-initiated programs. Currently the CRU operates with 2 MDs, 1 MD fellow, 1 research nurse, 2 study coordinators, and 1 regulatory liaison. A quality assurance program actively monitors ongoing studies, and the unit maintains a liaison with the IRB, the Office of Clinical Trials, the ICCR and the FDA. The unit welcomes and/or performs clinical trials for a variety of disorders including: psoriasis, acne vulgaris, viral and fungal diseases, allergies/urticaria, eczema, nail pathology, skin cancers, vascular malformations, cutaneous lymphomas, photoaging, autoimmune skin diseases, and blistering diseases. Please visit Research Capabilities for additional information.
The Clinical Research Unit is also actively involved in the various medical education programs of the department, including continuing medical education programs, the rotation of medical students through the unit as part of the Fourth Year Medical Student Clinical Dermatology Elective, and a Clinical Research Fellowship program supported by the Department.