After six courses directed to new incorporations into Clinical Research Ethics Committees (CREC), one step forward was deemed appropriate. This time, the contents were customized to fit active members of committees that work specifically in the field of cancer research. The objective was to update the main aspects involved in the assessment of cancer clinical trials and to exert some of the basic skills relating to this task.
The second edition of these new training seminars took place in Madrid on 1 March 2007. Theoretical sessions, further debates and a final practice session with evaluation of a real protocol were imparted by two expert professors (both of them active members of CRECs): Mª Ángeles de Cos, from the Clinical Pharmacology Service of the Hospital Marqués de Valdecilla University in Santander, and member of the CREC of the Community of Cantabria; and Manuel J. Valladares, from the Medical Oncology Department of the Hospital Juan Canalejo University of La Coruña, and member of the scientific and executive committee of the Spanish Group for the Treatment of Digestive Tumors (TTD) and of the Spanish (SEOM) and European (ESMO) Societies of Medical Oncology.
The seminar was held in the morning and in the afternoon –the latter dedicated entirely to the discussion of a real protocol– and included the following topics:
1. New therapeutic targets in Oncology. Background and history of anticancer pharmacology. Mechanism of action of anticancer drugs. Pharmacology and toxicology. Examples and news of cancer-directed treatments. The future of pharmacological treatments in oncology.
2. New legal framework in clinical research and its implications in Oncology. European and Spanish regulations. Issuing a single opinion and its local implications in the CRECs.
3. Clinical trial design in Oncology. General features of clinical trials in oncology. Rationale and objectives. The different phases of research. Screening criteria. Comparative groups: reference treatments. Justifications of independent oncology.
4. Other differential aspects relating to cancer clinical trials Endpoints in oncology. Tolerability evaluation. Changing research strategy with the new drugs. Informed consent. Sample management.