| The idiosyncracy of dermatology clinical trials poses key challenges to the pharmaceutical industry that require an imaginative response; Theresa Callaghan of proDERM reports
The therapeutic advances observed in dermatology today are based on the outcomes of carefully controlled clinical trials. With the development of novel therapies to treat a variety of skin diseases such as immunomodulators, retinoids, monoclonal antibodies, cytokines and so on, and the advances made through current scientific interest in the treatment of skin cancer and the consequences of age manifested in the skin, dermatology has developed its own unique position, not only within medicine, but also in clinical trials.
The most credible basis now widely accepted for evaluating both safety and efficacy of new dermatological drugs is data obtained from randomised controlled clinical trials. To prevent bias many Phase II and most Phase III drug trials are designed to be randomised, double-blind and placebo-controlled. The most commonly performed clinical trials evaluate new drugs, medical devices, or other interventions on patients in strictly controlled settings and are required for regulatory authority approval of new therapies (in the US, the Food and Drug Administration (FDA); in Canada, Health Canada; in the EU, the European Medicines Agency; in Japan, the Ministry of Health, Labor and Welfare). Although the conduct of clinical trials is becoming increasingly complex, due to technological advances and mounting regulatory and economic pressures, the opportunities within dermatological clinical trials, and moreover those conducted within dedicated dermatological clinical research organisations, are unique. |
