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...
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...
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...
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...
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...
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...
Patient advocates can be involved in early clinical development through partnerships and working relationships with regulatory authorities, ethics committees, investigators, and industry. They can provide input and play an...