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. Since then, the CRU has grown in size and developed into one of the nation’s most outstanding clinical research units in the field of dermatology. Under the direction of Dr. Julian Mackay-Wiggan, the CRU continues to design and participate in clinical trials of novel therapies for the treatment of dermatologic disorders. In addition, the CRU works in close collaboration with the Basic Science research group to facilitate the development of treatments for skin disease stemming from discoveries made in the laboratory (Translational Research).
The state-of-the-art Clinical Research Unit is located in the Herbert Irving Pavilion on the 12th floor within the Department of Dermatology’s newly renovated clinical facilities as part of the Columbia University Medical Center’s New York Presbyterian campus. The unit is equipped with dedicated, state-of-the-art patient examination and treatment rooms, as well as separate waiting areas. The research investigators and study coordinators are assigned contiguous office space that is fully-furnished with computers that are continually updated with the most recent software programs relevant to clinical research and medical care. In addition to standard dermatologic and general medical evaluation and examination apparatuses, the CRU has specialized tools for evaluating multiple parameters of skin structure, function and appearance including a spectrophotometer, cutometer®, and ultraviolet measurement devices. A fully-equipped medical photography studio, housed within the unit allows for high-quality, reproducible clinical photography (distance, close-up, and epiluminescent). There is a secure research drug storage and dispensing area as well as secure data storage facilities. Additionally, the CRU contains a medical refrigerator and -70°C freezer. State-of-the-art research pharmacy and infusion center facilities and services are readily available within the same building as the CRU and the NIH-funded Columbia University Irving Center for Clinical and Translational Research outpatient and inpatient facilities are also conveniently located. The CRU is experienced in and is fully operational for conducting all phases (0 through 4) of clinical research for multiple dermatologic diagnoses, including skin cancer, inflammatory and autoimmune skin disorders, infectious skin disease, as well as genetic disorders of the skin. The CRU also regularly collaborates with and provides consulting and/or clinical support to departments conducting clinical trials with non-dermatologic primary foci.
In addition to conducting trials in collaboration with 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 a team consisting of one or more board-certified dermatologists, fellows, study/nurse coordinators, and additional administrative staff to provide a fully functional and efficient research environment. 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 but not limited to: 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 First Year Medical Student Clinical Research Dermatology Elective, and a Clinical Research Fellowship program supported by the Department.