Participants of clinical trials have rights that are protected by law, and they also have specific responsibilities. Participants' organisations have close relationships with the patients in a clinical trial...
Phase II clinical studies, or proof of concept studies, begin to test the effect of a medicine on the target disease in humans. These studies are usually run as...
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability,...
A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose...
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...
Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatments participants have received during a clinical trial.
Introduction Patients were asked by GlaxoSmithKline staff members to review a draft plain language summary from a completed Phase III study. The patients provided valuable feedback about the wording,...
Introduction Novo-Nordisk, a pharmaceutical company, does user research with patients to enhance understanding of patients and to develop products that meet users’ needs. Where in the process? – Phase...