Follow-Up Survey of stakeholder actions following the EMA patient registry workshops

Study type

• Study topic:
  Other
• Study topic, other:
  Survey of stakeholder
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Survey of actions taken after registries workshops
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey

Population studied

• Short description of the study population:
  EMA Patient Registries Initiative team's regulatory colleagues who had attended at least one workshop.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  194

Study design details

• Main study objective:
  The aims were:1) to determine if the recommendations and actions agreed in each of the workshops by the stakeholders had been achieved, were under consideration, or if stakeholders were actively working on measures to be put in place in the short/long term2) to assess if views on the value of registries had changed following the workshops.
• Data analysis plan:
  The survey was anonymous. Participants were asked to provide their primary stakeholder group (registry holder, patient representative, regulator, marketing authorisation holder/applicant (MAH/MAA), health technology assessment (HTA) and/or reimbursement body) and the workshop attended. The survey consisted of common questions to be answered by all the participants and specific questions based on the stakeholder group and/or a specific workshop. Most questions asked respondents to choose a single answer from a list of 3-5 options. Broadly, the questions enquired about the status of workshop actions and recommendations, impact on views about registries, and collaboration between stakeholders including any new alliances or early dialogue between registries and MAH/MAAs on studies or protocols. Free text space was provided for respondents to expand on their answers, for example, to explain why recommendations from the workshop had or had not been implemented.

Documents

Study report

EMA Follow-Up Survey Report

Study publications

McGettigan P, Alonso Olmo C, Plueschke K, Castillon M, Nogueras Zondag D, Bahri…