Avrupa İlaç Ajansı (EMA)’ndan kalp yetmezliği tedavisi ilaçlarının klinik araştırmasına yönelik kavram raporu (İng)
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EMA issues concept paper on clinical investigation of cardiac failure treatment drugs.
EMA has issued a concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure (CPMP/EWP/235/95) draft.
Chronic Heart Failure (CHF) encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The CHMP Guideline on the clinical investigations of medicinal products for the treatment of cardiac failure (CPMP/EWP/235/95) addresses the development issues in this specific patient population. Recently, it became apparent that the scope of the guideline should be widened to include patients who are encountered in clinical practice and not previously addressed, including patients with preserved ejection fraction and with heart failure stabilized after an acute event, and also to elaborate on the endpoints to be studied.
The concept paper proposes that there should be discussion regarding the need to update the CHMP Note for Guideline on the clinical investigations of medicinal products for the treatment of cardiac failure (CPMP/EWP/235/95) in order to further enhance the following aspects:
- The inclusion of patients who are stable early after an acute de-compensation.
- The definition of Heart Failure according to the presence or absence of left ventricular dysfunction.
- Ways to measure the endpoint of hospitalisations.
The definition of endpoints that may be useful in the earlier phases of drug development in heart failure for further clinical trials.