The new EU clinical trial lay summaries - PMLiVE

abernard102@gmail.com 2016-03-09

Summary:

"As we continue to have greater access to health-related information, there are increasing examples of patients who have become self-educated to the point that they are instructing their physicians. And beyond that, there are patients who aren't waiting for the next healthcare innovation; they're inventing their own. These include a diagnostic test for pancreatic cancer, remote updates from a continuous glucose monitor and sensor technology for stoma care. Evidence suggests that the pharma industry is responding to increasingly engaged patients and their thirst for information, particularly in the areas of diagnosis, treatment initiation and adherence. An area that is surprisingly late to the table however is the cornerstone of medical research: the clinical trial. It seems fairly obvious that patients, and the general public, should be able to access and understand clinical trial results, and there have been increasing demands for these results to be provided in a patient-friendly format. The European Patients' Forum (EPF) believes this would have a number of benefits ... The new Clinical Trial Regulation (EU No 536/2014)5 comes into effect 'no earlier than May 2016'. It requires trial sponsors to provide two summaries one year after the end of the trial in the EU: a trial summary and a lay person summary. The European Medicine's Agency (EMA) will manage an EU database, hosting these summaries ..."

Link:

http://www.pmlive.com/pharma_news/the_new_eu_clinical_trial_lay_summaries_950074

From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com

Tags:

oa.new oa.comment oa.lay oa.medicine oa.biomedicine oa.ema oa.europe oa.policies oa.data oa.clinical_trials oa.pharma

Date tagged:

03/09/2016, 08:49

Date published:

03/09/2016, 03:49