Introduction A patients involved case report of patient feedback improving an informed consent form. UCB employees consulted patients with epilepsy and rheumatoid arthritis to make the form simpler and...
In the current Clinical Trials Directive, the definition of conditions for inclusion of vulnerable populations is limited to clinical trials with minors and incapacitated adults who are not able...
Introduction Partners from Ethic Committees (National Commission of Ethic Committees – CNCP), patient associations, and investigating centres worked in a writer’s guide of five recommendations and six rules for...
The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give...
Introduction A collaboration of the Patient Consumer Group [part of National Research Institute for Health Research (NIHR), Clinical Research Network] with the pharmaceutical company Eli Lilly. Where in the...
Introduction RWD and RWE are defined by the European Medicines Agency (EMA)[2] as a regulatory authority as such: RWD: “routinely collected data relating to a patient’s health status or...
Introduction A French patient association (La Ligue contre le cancer – http://www.ligue-cancer.net/), developed a collaboration with the Sanof-French Clinical Study Unit (CSU) to involve patients in the review of...
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
Published and available for citation: Klingmann I, Heckenberg A, Warner K, Haerry D, Hunter A, May M and See W (2018) EUPATI and Patients in Medicines Research and Development:...
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard...
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