EU-X-CT - TF3 Mapping: The EU Cross-border Clinical Trials Multi-Stakeholders Initiative (ALL STAKEHOLDERS)
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  • The EU Cross-border Clinical Trials Multi-Stakeholders Initiative

    Borders should no longer be barriers

  • Dear colleague,

     

    We highly appreciate your support for this initiative by providing detailed answers to the questions below regarding national information on practical and operational aspects and options based on your experience participating in cross-border trials.

    It should take no longer than 10-15 minutes to answer.

  • What is your profile?*

  • Questions to People/Operational experts – INVESTIGATORS

    Initial questions for a basis for selection and understanding the background

  • Questionnaire on people and operations cross-border access to clinical trials

     

    We welcome you and thank you for your interest in our EU-X-CT Initiative.  This is an initiative that seeks to improve cross-border access to clinical trials (in another country) for patients, as well as better facilitate clinical principal investigators seeking to enrol such patients from other EU and other European countries.

    The EU-X-CT Initiative, funded by The European Federation of Pharmaceutical Industries and Associations (EFPIA), aims to bring together reliable and accessible information regarding legal, regulatory, and ethical as well as practical aspects of conditions and options for cross-border access to clinical trials, with medicinal products (drugs) according to Article 2.2 of the EU Clinical Trial* Regulation 536/2014  or respective national law. This is particularly important for patients that have a life-threatening and/or rare disease(s) for whom a medicinal product (experimental) might be the only therapeutic option.

    The purpose of this survey is to help us undertake a mapping exercise that will better understand cross-border access to clinical trials. We are interested in understanding more explicitly both concerns around people and operations, as well as barriers/specific hurdles faced by all stakeholders, including clinicians and principal investigators, patients and their families, and Clinical Research Organisations (CROs).

    The responses we collate from the survey will be used by mapping the current situation and will be presented to relevant stakeholders and guide future action planning.  In the process of conducting the survey, we may/will collect some personal data. We may wish to contact you for follow-up (if needed), but you are free to opt-out of future communications with us should you wish. Moreover, we would like to share with you the results from the survey outputs, including the mapping exercise and outcomes resulting from the work, and invite you to attend future EU-X-CT events.

    *‘Clinical trial’ means a clinical study that fulfils any of the following conditions:
    (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within the normal clinical practice of the Member State concerned;
    (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
    (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

  • We are aware of the complexity of the topic and the questionnaires. It is possible that you would not be able to answer all questions. This does not matter. Any information you can share is valuable and it does not have to be fully complete.

  • Are you currently (or during the past 24 months) conducting or playing an active part in an ongoing clinical trial?*
  • Are you taking part as:*
  • Which type of center are you working in?*
  • How many clinical trials are conducted in the institute you work in, in a year?*
  • Does your site provide options for a participant coming from abroad and who is not covered by your national health care system to take part in your clinical trial (cross-border access to a clinical trial)?*
  • Rows
  • How many participants (patients) who were not covered by your health care system (i.e. patients coming from/resident in another country) have you enrolled in the last 24 months in a clinical trial at your clinic/site/hospital?
  • According to your experience, do you think that there are eligible participants, patients not resident in the country where you are conducting the clinical trial that are not enrolled?*
  • Rows
  • As an investigator, did you ever experience a difficult situation where you wanted to enroll a patient from abroad, but you encountered significant challenges that created a high work burden and additional time investment? Did this influence your decision so that you did not include that patient?*
  • Rows

  • Administrative and/or organizational procedure

  • Have you had to conduct additional administrative and/or organizational procedures at the hospital/clinical trial site when trying to enroll participants (patients) who were not part of your healthcare system (cross-border patients) and were not self-funded patients?*
  • Rows
  • Have you ever experienced issues accessing medical information for participants (patients) who were not part of your healthcare system (cross-border patients)?*
  • Rows
  • Did you experience any particular challenges specifically among cross-border patients participating in clinical trials? E.g in ensuring protocol compliance and follow-up visits?*
  • Was the compliance with the clinical protocol requirements the same?*
  • Were there problems in enabling participants to show up for both clinical study visits and follow up visits?*
  • Were there problems you experienced with facilitating follow-up visits after the end of the active part of trial?*
  • Have you ever experienced issues with getting trial medication sent to the cross-border patients’ homes when they returned to their country of residence?*
  • Rows

  • Logistics

  • Rows
  • Have you ever experienced issues with accommodation access for participants in the vicinity of the hospital for patients who were not part of your health care system (cross-border patients self-funded/self-paying )?*
  • Rows
  • Have you ever experienced issues with logistics arrangements for patients who were not part of your health care system (cross-border patients) and were self-funded/self-paying?*
  • Rows

  • Language & Cultural

  • Have you ever experienced problems with language barriers at the hospital/trial site when conducting a clinical study and enrolling patients who were not part of your healthcare system (cross-border patients)?*
  • Rows
  • Have you experienced problems with cultural barriers at the hospital/clinical trial site, when conducting a clinical study, enrolling patients who were not part of your healthcare system (cross-border patients)?*
  • Have you had any other problems when trying to enroll patients who were not part of your health care system (cross-border patients) and were self-funded/self-paying?*
  • Have you used digital technologies to support the participation of patients who were not part of your health care system (cross-border patients) in a clinical trial at your hospital/clinical site?*
  • Rows
  • Have you experienced issues with the continuation of medical care for those who were not part of your health care system (cross-border patients) after they returned to their country of residence?*
  • Rows
  • Have you ever experienced issues with the continuation of medical care for those participants (patients) who were not part of your health care system (cross-border patients) after they returned to their country of residence after the active part of clinical trial completed?*
  • Rows
  • What were your cross-border patients' disease(s)? (multiple answers possible)*
  • To which specific class or category did the investigational medicinal product (IMP) utilized in the study clinic belong? (please select the most appropriate answer)*
  • What was the administration route of the investigational medicinal product(s) in the clinical trials?*

  • Questions to People/Operational experts – CRO / Sponsors

    Initial questions for a basis for selection and understanding the background

  • Questionnaire on people and operations cross-border access to clinical trials

     

    We welcome you and thank you for your interest in our EU-X-CT Initiative.  This is an initiative that seeks to improve cross-border access to clinical trials (in another country) for patients, as well as better facilitate clinical principal investigators seeking to enrol such patients from other EU and other European countries.

    The EU-X-CT Initiative, funded by The European Federation of Pharmaceutical Industries and Associations (EFPIA), aims to bring together reliable and accessible information regarding legal, regulatory, and ethical as well as practical aspects of conditions and options for cross-border access to clinical trials, with medicinal products (drugs) according to Article 2.2 of the EU Clinical Trial* Regulation 536/2014  or respective national law. This is particularly important for patients that have a life-threatening and/or rare disease(s) for whom a medicinal product (experimental) might be the only therapeutic option.

    The purpose of this survey is to help us undertake a mapping exercise that will better understand cross-border access to clinical trials. We are interested in understanding more explicitly both concerns around people and operations, as well as barriers/specific hurdles faced by all stakeholders, including clinicians and principal investigators, patients and their families, and Clinical Research Organisations (CROs).

    The responses we collate from the survey will be used by mapping the current situation and will be presented to relevant stakeholders and guide future action planning.  In the process of conducting the survey, we may/will collect some personal data. We may wish to contact you for follow-up (if needed), but you are free to opt-out of future communications with us should you wish. Moreover, we would like to share with you the results from the survey outputs, including the mapping exercise and outcomes resulting from the work, and invite you to attend future EU-X-CT events.

    *‘Clinical trial’ means a clinical study that fulfils any of the following conditions:
    (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within the normal clinical practice of the Member State concerned;
    (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
    (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

  • We are aware of the complexity of the topic and the questionnaires. It is possible that you would not be able to answer all questions. This does not matter. Any information you can share is valuable and it does not have to be fully complete.

  • Are you currently (or during the past 24 months) conducting or playing an active part in an ongoing clinical trial?*
  • Are you taking part as:*
  • Which type of center are you working in?*
  • How many clinical trials are conducted in the institute you work in, in a year?*
  • Have you experienced a patient coming from abroad who is not covered by the country of the clinical trial site’s national health care system - cross-border access to a clinical trial? (i.e do they have cross-border access to a clinical trial)?*
  • Rows

  • How many participants (patients) who were not covered by the country of clinical trial site’s health care system (ie. patients coming from/resident in another country) have you seen enrolled in the last 24 months in a clinical trial that you worked in?

  • According to your experience, do you think that there are eligible participants, patients not resident in the country where you are conducting the clinical trial that are not enrolled?*
  • Rows
  • As a clinical trial research professional, did you ever experience a difficult situation where a clinician wanted to enrol a patient from abroad, but the challenges involved would have created a high work burden and additional time investment so the clinician had actively decide not to include the patient?*
  • Rows

  • Administrative and/or organizational procedure

  • Have you had to conduct additional administrative and/or organizational procedures at the hospital/clinical trial site when trying to enrol participants (patients) who were not part of clinical trial site’s healthcare system (cross-border patients) and were not self-funded patients?*
  • Rows
  • Have you ever experienced issues accessing medical information for participants (patients) who were not part of clinical trial site’s healthcare system (cross-border patients)?*
  • Rows
  • Did you experience any particular challenges specifically among cross-border patients participating in clinical trials? E.g in ensuring protocol compliance and follow-up visits?*
  • Was the compliance with the clinical protocol requirements the same?*
  • Were there problems in enabling participants to show up for both clinical study visits and follow up visits?*
  • Were there problems you experienced with facilitating follow-up visits after the end of the active part of trial?*
  • Have you ever experienced issues with getting trial medication sent to the cross-border patients’ homes when they returned to their country of residence?*
  • Rows

  • Logistics

  • Rows
  • Have you ever experienced issues with accommodation access for participants in the vicinity of the hospital for patients who were not part of the clinical trial site’s health care system (cross-border patients self-funded/self-paying )?*
  • Rows
  • Have you ever experienced issues with logistics arrangements for patients who were not part of the clinical trial site’s health care system (cross-border patients) and were self-funded/self-paying?*
  • Rows

  • Language & Cultural

  • Have you ever experienced problems with language barriers at the hospital/trial site when conducting a clinical study and enrolling patients who were not part of your healthcare system (cross-border patients)?*
  • Rows
  • Have you experienced problems with cultural barriers at the hospital/clinical trial site, when conducting a clinical study, enrolling patients who were not part of the country of the clinical trial site’s healthcare system (cross-border patients)?*
  • Have you had any other problems when trying to enrol patients who were not part of the country of the clinical trial site’s health care system (cross-border patients) and were self-funded/self-paying?*
  • Have you used digital technologies to support the participation of patients who were not part of your health care system (cross-border patients) in a clinical trial?*
  • Rows
  • Have you experienced issues with the continuation of medical care for those who were not part of the country of the clinical trial site’s health care system (cross-border patients) after they returned to their country of residence?*
  • Rows
  • Have you ever experienced issues with the continuation of medical care for those participants (patients) who were not part of the country of the clinical trial site’s health care system (cross-border patients) after they returned to their country of residence after the active part of clinical trial completed? (In case this question is relevant for you)*
  • Rows
  • What were your cross-border patients' disease(s)? (multiple answers possible)*
  • To which specific class or category did the investigational medicinal product (IMP) utilized in the study clinic belong? (please select the most appropriate answer)*
  • What was the administration route of the investigational medicinal product(s) in the clinical trials?*

  • Participants Information

  • Personal Data

  • Would you be interested in follow-ups on this mapping exercise by the EU-X-CT?*
  • I agree to be contacted by EFGCP for other activities/surveys/events related to the EU-X-CT*

  • Terms of Use and Data Protection Policy

  • By submitting this form, you agree that the information provided in this questionnaire can be used for the purpose of EU-X-CT mapping exercise.


    We respect your trust, and protecting personal data is important to us. Therefore, we act in accordance with the European General Data Protection Regulation (GDPR). By filling in this form, you agree that your anonymous responses will be shared with the EU-X-CT Core Management Team and the EU-X-CT Members carrying out the mapping exercise. If you agree to be contacted, an EU-X-CT member from a patient organisation, academia or not-for-profit organisation will receive your personal information and contact you so that you can provide further information on cross-border access to a clinical trial. Your personal data will be handled by EFGCP within the framework of the EU-X-CT Project according to the EFGCP Privacy Policy. If you have additional questions on the data privacy policy, or if you might want to have your personal data deleted or amended, you can contact the EFGCP Data Protection Officer of the EFGCP in writing at secretariat@efgcp.eu.

    In the scope of this survey, EFGCP will process your data as a data controller for the purposes that were presented to you. The legal basis for processing your personal data is consent (Article 6(1)(a) of Regulation (EU) 2016/679). Your data will be processed according to the EFGCP Privacy Policy.

    By filling out this survey, you agree for your personal data to be stored by EFGCP and made accessible to the EU-X-CT Members. You have the right to ask your data to be amended or deleted by contacting secretariat@efgcp.eu.


    EFGCP will provide its services in a professional and compliant manner using best efforts to protect personal data. When sharing your personal data for the purpose of the EU-X-CT Project to the participating stakeholders, EFGCP will implement appropriate safeguards. Each participating stakeholder is an independent controller and has agreed to carry out the tasks assigned to it in this Project with care and diligence applying their own safeguards for the received personal data. The parties hereto acknowledge and agree that nothing in this statement contained, and nothing done pursuant hereto by participating stakeholders shall be deemed to constitute a direct or indirect guarantee by EFGCP of any liability. EFGCP cannot be held responsible for any data leaks, IT issues, hacks, misuses, or any harms to you, your organisations or your activities, due to your involvement in the EU-X-CT Project Activities

     
    Personal Data Gathered:

    • Name, Surname
    • eMail Address
    • Organisation, Role
    • Country

  • Thank you for your time and completing this survey. Your contribution is valuable and much appreciated, it will help us to improve our understanding of cross-border access to clinical trials for patients.

    If you would have any questions or require additional information, please contact the EU-X-CT Secretariat at eu-x-ct@efgcp.eu

    Yours sincerely

     EU-X-CT Team

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