Direct to Patient (D2P) shipment for Clinical Trials - Survey
Dear Sponsor, CRO, Investigator or Patient,
Within Europe and more specifically within Belgium, Direct To Patient (D2P) shipments have limitations within the current regulatory framework. Considering the growing enthusiasm of pharma companies, investigators and patients performing D2P shipments in the US, we need to investigate if the European market should not adapt its regulations in order to respond to this new demand.
A working group has been established with participation of the Belgian Federal Agency for Medicines and Health Products (FAMHP), the Ministry of Social Affairs & Public Health, Patient organizations especially EUPATI, Industry, Academic Organizations as well as Industry Associations to further explore these options and understand the regulatory implications.
In an effort to influence current regulations, this working group is reaching out to You, as stakeholder in Clinical Trials, to share your current experience and future interest on D2P by completing this questionnaire.
This survey will help define and scope the needs of D2P shipments in EU and support the need to change the current regulations in order to meet the evolving needs of the patients participating in clinical trials.
Thank you for taking the time to answer this questionnaire by 31st January 2018.
· For the purpose of this questionnaire, D2P means shipment of IMP from a clinical site to a patient, from a pharmacy to a patient or shipments from a depot to a patient.
· For the purpose of this questionnaire, Company refers to the whole organization (on a global scale). Some questions refer to previous experience with D2P, which can exist within your organization at an international level.
· It is possible that answering this questionnaire requires the input of different business units of your organization. Please take the time to consolidate information with your colleagues and provide company's response to the questions.
· In any case, your feedback will be treated anonymously. If you wish to receive the survey's output, you can provide your email.
The D2P Working Group
https://www.surveymonkey.co.uk/r/D2PSponsor (Sponsor Survey)
in DUTCH: https://www.surveymonkey.co.uk/r/FSTZ2H8
in ENGLISH: https://www.surveymonkey.co.uk/r/FSTZ2H8?lang=en
https://www.surveymonkey.co.uk/r/RYSM8WYCRO (CRO Survey)
https://www.surveymonkey.co.uk/r/VQHSKX2Investigators (Investigator Survey)