The method of randomized trials, as performed by WHO, has definitely been a legitimate clinical study design in patients with melanoma from about 1970 to the end of the last century. Three important results of these WHO trials have substantially influenced the approach of the clinician towards melanoma: (1) There is no role for elective regional lymph node dissection; (2) narrow local excision of the primary melanoma does not entail additional risks; and (3) adjuvant treatment with chemotherapy and immunotherapy after radical surgery for regional lymph node metastases did not, until now, show substantial benefit. A problem is that the randomized clinical study requires long periods of time for its completion and often, subsequently, its legitimacy is challenged because of the emergence of new parameters, both regarding staging (for instance the introduction of sentinel node biopsy) and prognosis. Therefore, it would be better to define different clinical study models to quickly test a hypothesis on a small group of selected patients in order to give a fast answer. We believe that this is the future of clinical research in the new millennium, because it does not seem reasonable anymore to plan large clinical trials that need 10 years or more of accrual and follow-up without reaching definite conclusions.
|Number of pages||13|
|Journal||Surgical Oncology Clinics of North America|
|Publication status||Published - 2001|
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