The second EUPATI webinar will discuss how patients can contribute to the ethical review of trials and products. As a public-private partnership, EUPATI is ideally placed to generate a broader dialogue on the importance of increased patient involvement in this area.
HTA is a multidisciplinary process that examines the information about medical, cost-effectiveness, social, political, legal and ethical considerations of the application of a health technology – usually a medicine, medical device or clinical/surgical procedure. The main purpose of conducting an assessment is to inform policy decision making, which has an impact on patients and their ecosystem of health, including physicians and payers.
The webinar will examine the need for patient involvement in HTA and look at the HTA landscape in Europe. A patient organisation representative will present a case study on patient participation in HTA, and the conversation will also look at how the EUPATI toolkit can help informed patients engage in HTA.
How early in the development of a new medicine should thEarly collaboration – a recipe for solutions: drug development and treatment strategies may go hand in hand.e discussion between researchers and patients occur? Can such early strategic interaction really maximize the value of the outcome? In this EUPATI webinar, a pharmaceutical industry researcher and a patient expert will present two cases describing the research questions, their interaction and the outcome of this early collaboration. Join us in listening and discussing two very interesting experiences of successful patient involvement in the development of new medicines.
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 to give informed legal consent. Released in April 2014, the new “EU Clinical Trial Regulation” (EU Regulation 536/2014) expands on information given for the above populations. Additionally, it also goes further and defines the conditions, especially the informed consent process for clinical trials in pregnant and breast feeding women as well as in emergency situations. Although, the objective is to harmonise the performance of clinical trials in Europe, certain opt-out options for Member States are foreseen and thus might lead to exclusion of certain countries from some trials.