Returning Clinical Trial Data to study participants within a GDPR compliant and approved ethical framework (2nd stage)

Estado

Pendent de resolució

Área gestora

Oficina de Projectes Internacionals

Entidad convocante

No aplica

Programa

IMI2 - Innovative Medicines Initiative 2016

Área temática

No aplica

Tipo de ayuda

PJE_Projectes Europeus

Destinatarios

  • Grups de Recerca (GRU)
  • Investigadors/es (INV)

Descripción

A large amount of high-quality health data is collected during clinical studies (interventional and non-interventional), but, beyond the immediate objectives of the study, these valuable data are not used to the extent they merit. Subject to appropriate legal grounds, these data could be used to enrich patients’ healthcare records to improve clinical decision-making and reduce duplication in procedures/investigations. In addition, returning clinical trial data to patients could allow them to contribute their data for additional scientific research (e.g. patient-powered research), in particular for rare diseases where treatments and data are scarce or unavailable. Finally, the lack of transparency and sharing of clinical trial data could contribute to the lack of patient willingness to be involved in studies, delays in clinical study set up and conduct, and delays in conducting health research in Europe to the detriment of vulnerable patients and public interest in general.

Bases de la convocatoria

Consultar bases

Web con más información

Consultar web

Fecha de publicación

23/06/2020

Fecha de inicio de solicitudes

23/06/2020

Fecha de presentación en la UAB

No aplica

Fecha de fin de solicitudes en el Organismo convocante

17/03/2021

Fecha de resolución prevista

17/08/2021

Resolución

No aplica