EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information…
Call for all sponsors to publish clinical trial results in EU database The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of…
ICH Releases Draft Revision of E8 Guideline, General Considerations for Clinical Trials Since the last update of ICH6 (R2) on 2017, ICH was working on a new release, a new revision of ICH E8 about General Considerations for…
Acknowledgment for APICES collaboration in a clinical trial published in The Oncologist. Many times the work of CROs is not totally acknowledged. But, fortunately, this is not always the case. This month, we want to share the acknowledgment…
CTFG KEY RECOMMENDATIONS TO CONDUCT A COMPLEX CLINICAL TRIAL The Clinical Trials Facilitation and Coordination Group has drawn up a document that provides recommendations for sponsors regarding the authorization and conduct of complex clinical trial from a current…
GUIDANCE ON ONCOLOGY ENDPOINTS: FDA REVISION Clinical trial endpoints serve to different objectives: In early phase, clinical trials evaluate safety and evidence biological drug activity; for later phase efficacy studies evaluate the clinical benefit. Food and Drug Administration…
Update of Annexes II, V and VIIIC of the AEMPS for the conduct of clinical trials in Spain The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain. Annex II. Security…
Use of electronic health record data in clinical investigations Electronic health record (EHR) systems are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health…
Endpoints en ensayos clínicos: Ventajas y desventajas Los endpoints primarios en ensayos clínicos deben basarse en 3 requisitos: Ser clínicamente relevantes. Relacionados con el efecto del tratamiento. Medibles e interpretables. Los endpoints secundarios pueden aportar una visión más…
Actualización de los criterios de selección de pacientes en ensayos clínicos Estimados amigos, En el recientemente celebrado congreso anual de la Asociación Americana de Oncología Clínica (ASCO) se ha presentado un trabajo en el que ASCO, Friends of…
