Patient Community Advisory Boards (CABs) are consulting bodies established, operated and maintained by disease specific, clinical trial specific, or company specific groups of patient advocates and expert patients to discuss, in a neutral, unbiased and critical setting, the latest developments, challenges and issues related to health technologies that concern the…
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Many randomized clinical trials are double blind – no one involved with the trial…
HTA stands for Health Technology Assessment. The main aim of HTA is to inform decision making by health care policy makers. It is a systematic process that considers health technologies (such as medicines or medical devices) and can involve a review of: clinical effectiveness (how well a medicine will work…
IMI Survey “Patient involvement in IMI projects” In August 2013, the Innovative Medicines Initiative (http://imi.europa.eu) conducted a survey amongst all IMI projects on “Patient involvement in IMI projects”. The results provide interesting learnings on patient (advocacy group) involvement in R&D projects. The most common reason for not involving patients in…
Patient involvement in research: Introduction The development of new therapies is a highly regulated, costly, long and complex process. In an era of growing demand and emphasis on patient-centricity, quality and sustainability of healthcare, it is critical to address this major gap in public perception and knowledge. Well informed patients…
European Patients Academy on Therapeutic Innovation (EUPATI) The IMI-funded ‘European Patients Academy on Therapeutic Innovation’ aims to educate patient advocates and lay public about medicines R&D processes. The Innovative Medicines Initiative (IMI, http://imi.europa.eu), a public private partnership between the European Commission and EFPIA, will fund a patient-led consortium to develop…
Some ideas of the roles that patient advocates could play in the medicines development process include: Setting priorities and cross-cutting issues Contributing to early horizon scanning, target product profile definition, intended research outcomes Ensuring that patients’ needs are considered within the research process Facilitating relationships between key stakeholders in medicines…
Optimizing Informed Consent Documents Informed consent documents are often difficult to read an understand. We have run a number of projects to improve the presentation amnd readability of [[Informed Consent]] documents in clinical trials.
