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 were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the…
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 their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are fundamental…
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 Clinical Trials. The E8 last version was adopted in 1997, but changes to trial design and conduct in the last two decades have made much of the guideline out…
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 that APICES has received in a recent publication in The Oncologist. This means to all APICES team an extra motivation in order to give continuity to the implication we…
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 perspective. In this document, a complex clinical trial is considered to have a complex clinical trial design if it has separate parts that could constitute individual…
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 care institutions and are used to deliver care. The EHR systems can be an interesting chance in clinical investigation: to improve data accuracy and promote clinical…
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 global del beneficio de tratamiento que está siendo estudiado y de su relación beneficio- riesgo; pueden ser de dos tipos: Aquellos que, como los…
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 Cancer Research y la FDA utilizaron las recomendaciones del trabajo original de ASCO para identificar los criterios de elegibilidad que con mayor probabilidad restringirían la participación de los…
El VIII Seminario Fundación ECO, organizado de manera conjunta con la Real Academia Nacional de Medicina, ofreció un foro de debate y discusión en esta ocasión, sobre la evaluación y los resultados de salud en Oncología. Oscar Salamanca, director general de APICES, reflexionó sobre las debilidades y fortalezas de los End Points en Oncología Médica, sobre la interpretación…
Los procesos excesivamente complejos y burocratizados, y la fragmentación de las autorizaciones entre las distintas autoridades a nivel europeo e interno son los principales óbices que intenta solventar el Reglamento 536/2014 del Parlamento Europeo y del Consejo, de 16 de abril de 2014, que deroga la anterior Directiva 2001/20/CE y en España, el Real Decreto…