During clinical development the manufacturing and distribution facilities available may not be suitable for a trial medicine (investigational medicinal product (IMP)), however, IMPs must be manufactured, stored and distributed...
Medicine adherence (also known as ‘patient adherence’ or ‘compliance’) is how well patients follow doctors’ instructions about the timing, frequency, and dosage when taking a medicine.
A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from clinical...
‘Within-trial decisions’ are decisions made once a clinical trial has already begun, for instance if an unexpected problem comes to light. This article looks at two specific kinds of...
To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or...
An example of patient involvement looking at a case report on Phase III patient involvement in an advisory board comprising six expert GYN oncology nurses from across Europe and...
A collaboration of Genzyme, International Pompe Association (IPA); UK, Dutch, and US Pompe patient organisations, Erasmus Medical Center and Duke University to establish appropriate measures to ensure the data...
A French patient association (La Ligue contre le cancer - http://www.ligue-cancer.net/ ), developed a collaboration in oncology with the Sanofi-French Clinical Study Unit (CSU) to involve patients in the...
Expert melanoma nurses and advocacy group experts held a Melanoma board meeting to explore perceptions about novel treatments and scientific developments in the management of melanoma.
A Patients Involved case report on an R&D collaboration between the European AIDS Treatment Group, European Liver Patients Association, Treatment Action Group, and Janssen R&D.
