Acknowledgment for APICES collaboration in a clinical trial published in BMC Cancer. This month, we want to share the acknowledgment that APICES has received in a recent publication in BMC Cancer in which APICES has collaborated in several tasks of the project. This means to all APICES team an extra motivation in order to give…
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 were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing…
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 their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).…
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 Clinical Trials. The E8 last version was adopted in 1997, but changes to trial design and conduct…
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 that APICES has received in a recent publication in The Oncologist. This means to all APICES team…
AEMPS UPDATES GCP SECTION On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated: New version of serious protocol breaches notification form. Prohibition of FDA 1572 form in clinical trials carried out in Spain. Those clinical trials must follow Spanish laws 2001/20/EC, 2001/83/EC y 2005/28/EC and Regulation (EU) No. 536/2014…
NEW TREATMENT OPTION FOR PATIENTS WITH SPINAL CORD INJURY This month has been published a relevant article about a new therapeutic advance. A patient with spinal cord injury can walk again after being treated with NC1, a new cell therapy produced at Hospital Puerta de Hierro from Madrid, Spain. The medical team from Hospital Puerta…
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 perspective. In this document, a complex clinical trial is considered to have a complex clinical trial design…
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 (FDA) has revised the previous guidance on oncology endpoints published in May 2007. This guidance provides recommendations…
MERRY CHRISTMAS AND HAPPY 2019 – APICES 10 YEARS OLD Next year is very close and is time to think about results of this year, time to celebrate successes and to be enthralled with the beginning of new projects and challenges for 2019. Moreover, 2019 is really a very special year, APICES will be 10…
