EU-X-CT TF2 Mapping: Your experience in your country in financial handling of patients seeking cross-border access to a Clinical Trial in Europe
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  • The EU Cross-Border Clinical Trials Multi-Stakeholders Initiative

    Questionnaire: Your experience in your country in financial handling of patients seeking cross-border access to a Clinical Trial in Europe
  • We need your help to understand how patients can join clinical trials that are not performed in your country but in other European countries.
     
    We are reaching out on behalf of the EFGCP-EFPIA Cross-Border (EU-X-CT) Initiative that aims to bring together reliable and accessible information regarding cost coverage, liability insurance, legal, regulatory, ethical as well as operational aspects on conditions and options for patients’ cross-border access to clinical trials.
     
    Participation in a clinical trial is an important element of healthcare, especially for patients with life-threatening and/or rare diseases for whom a medicinal product under investigation might be the only therapeutic option.
     
    While clinical trials are conducted in line with existing legislations such as the European Regulation [(EU) No 536/2014] on clinical trials on medicinal products for human use, there is no legal European framework that defines the conditions for accessing clinical trials in another European country. This is why there is need for reliable and accessible information to optimise cross-border access to clinical trials.
     
    Therefore, we would greatly appreciate your support of this Initiative by providing detailed answers to the questions below about your experience with coverage of healthcare costs for trial participants who participated in a clinical trial outside your country, and where these costs were NOT covered by the trial sponsor.
     
    Some of the following questions are addressed to a particular stakeholder group. If you don’t belong to this group, please tick “Not Applicable”.
     
    The first questionnaire has a general scope and is aimed at academia, not-for-profit organizations, patient organizations, health insurance companies, hospital administrators, clinical investigators.
     
    The second questionnaire for stakeholders involved in handling the costs for patients from another country that participate in a Clinical Trial in your country.
     
    The third questionnaire is for sponsors of a Clinical Trial (pharmaceutical industry, medical device industry, academia, sponsor-investigator).
     
    We would appreciate it if you allowed us to contact you for an interview in case we would need further details/information from you.

  • 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.

  • To which questionnaire would you like to answer?*

  • Organisation type

  • Organization type: Please select the option that best describes your organization*
  • Do you have experience with the financial hurdles for patients in your country wanting to join a Clinical Trial in another country?*
  • Please specify (multiple choice possible):*
  • Are you aware of patients (who were covered by your country’s health care system) who tried to find coverage for costs not covered by the trial sponsor like travel and/or baseline diagnostic and therapy costs when joining a Clinical Trial in another country? Or have you tried to help a patient to achieve such financial coverage?*
  • Please specify (multiple answers possible):*
  • Are you aware of trial participants who have asked your national health care system to cover additionally occurring costs like adverse-event related medical care or long-term baseline medication between their study visits at a site in another country? Or have you helped a patient to achieve such health care system coverage in the patient’s home country?*
  • Please specify (multiple answers possible)*
  • Are you aware of trial participants who asked for follow-up health care costs occurring in your country to be covered after they had participated in a clinical trial in another country? Or have you tried to help a patient to achieve such financial coverage?*
  • Please specify (multiple answers possible)*
  • Are you aware of any pre-requisite, minimal requirements, limitations and/or exclusion rules in your country’s health care system concerning financial coverage of costs for patients participating in a clinical trial abroad?*
  • Please specify (multiple answers are possible)*
  • Are you aware of any specific procedure, infrastructure and/or recommendations to enable a patient, covered by your national health care system, to participate in a clinical trial abroad?*
  • Please specify (multiple answers are possible)*

  • Your experience in the liability and health care insurance of patients seeking cross-border access to a Clinical Trial in another country

  • We need your help to understand how it is possible to join clinical trials that are not performed in your countries but in other European countries.
     
    We are reaching out on behalf of the EFGCP-EFPIA Cross-Border (EU-X-CT) Initiative that aims to bring together reliable and accessible information regarding cost coverage, liability insurance, legal, regulatory, ethical as well as operational aspects on conditions and options for patients’ cross-border access to clinical trials.
     
    Participation in a clinical trial is an important element of healthcare, especially for patients with life-threatening and/or rare diseases for whom a medicinal product under investigation might be the only therapeutic option.
     
    While clinical trials are conducted in line with existing legislations such as the European Regulation [(EU) No 536/2014] on clinical trials on medicinal products for human use, there is no legal European framework that defines the conditions for accessing clinical trials in another European country. This is why there is need for reliable and accessible information to optimise cross-border access to clinical trials.
     
    Therefore, we would greatly appreciate your support of this Initiative by providing detailed answers to the questions below about your experience with coverage of the costs for patients that are NOT covered by the trial sponsor when patients want to join a Clinical Trial in another country.
     
    We would appreciate it if you allowed us to contact you for an interview in case we would need further details/information from you.
     
    Some of the following questions are addressed to a particular stakeholder group. If you don’t belong to this group, please tick “Not Applicable”.
  • Please select the option that best describes your organization:*
  • As a Liability Insurer for clinical trials, do you provide liability insurance coverage to patients that are NOT covered by your investigator country's healthcare system when joining a Clinical Trial outside their country of residence?*
  • Rows
  • As an insurance company, have you been asked to cover screening costs like travel, baseline diagnostic and/or therapy costs for patients from another country (under another health care system) that wanted to join a clinical trial in your country but failed the screening? Or have you tried to help a patient to achieve such coverage in your country?*
  • Rows
  • As an insurance company, have you been asked to cover costs like travel, baseline diagnostic, therapy and/or hospital stay costs for patients from another country (under another healthcare system) that were successfully enrolled in a Clinical Trial in your country? Or have you helped a patient to achieve such coverage?*
  • Rows
  • As an insurance company, have you been asked to cover additionally occurring costs like adverse-event-related medical care or long-term baseline medication in the patient’s home country between study visits? Or has your insurance company helped a patient to achieve such coverage in the patient’s home country?*
  • Rows
  • As an insurance company, have you been asked by patients  to cover the follow-up healthcare costs in the patient’s home country after participation in a Clinical Trial in another country? Or have you helped a patient to achieve such coverage in the patient’s home country?*
  • Rows
  • Are you aware of any pre-requisites, minimal requirements, limitations and/or exclusion rules in your country concerning financial coverage of costs for patients participating in a Clinical Trial who are coming from another country?*
  • Please Specify (multiple answers are possible)*
  • Are you aware of any specific procedure, infrastructure and/or recommendations to enable a patient from another country, to participate in a clinical trial at a site in your country? (multiple answers possible)*
  • Please specify (multiple answers are possible)*

  • Your experience as a sponsor in the financial handling of patients seeking cross-border access to a clinical trial in another European country

  • We need your help to understand how patients can join clinical trials that are not performed in your country but in other European countries.
     
    We reaching out on behalf of the EFGCP-EFPIA Cross-Border (EU-X-CT) Initiative that aims to bring together reliable and accessible information regarding cost coverage, liability insurance, legal, regulatory, ethical as well as operational aspects on conditions and options for patients’ cross-border access to clinical trials.
     
    Participation in a clinical trial is an important element of healthcare, especially for patients with life-threatening and/or rare diseases for whom a medicinal product under investigation might be the only therapeutic option.
     
    While clinical trials are conducted in line with existing legislations such as the European Regulation [(EU) No 536/2014] on clinical trials on medicinal products for human use, there is no legal European framework that defines the conditions for accessing clinical trials in another European country. This is why there is need for reliable and accessible information to optimise cross-border access to clinical trials.
     
    Therefore, we would greatly appreciate your support of this Initiative by providing detailed answers to the questions below about your experience with coverage of healthcare costs for trial participants who participated in a clinical trial outside your country, and where these costs were NOT covered by the trial sponsor.
     
    We would appreciate it if you allowed us to contact you for an interview in case we would need further details/information from you.
  • Please select the option that best describes your organization:*
  • Have you signed a contract with a liability insurance company that also covers clinical trial-related damage that occurs to patients from abroad who are NOT covered by the national health care system in the country where the site is located?*
  • Rows
  • As a Sponsor, have you been asked to cover the non-Clinical Trial related costs like travel and/or baseline therapy costs for patients (under another healthcare system) that wanted to join a Clinical Trial in another country but failed screening? Or have you tried to help a patient to achieve such coverage?*
  • Rows
  • As a Sponsor, have you been asked to cover the non-Clinical Trial related costs like travel, baseline diagnostic and therapy and/or hospital stay costs for patients (under another healthcare system) that were successfully enrolled in a Clinical Trial in another country? Or have you helped a patient to achieve such coverage?*
  • Rows
  • As a Sponsor, have you been asked to cover additionally occurring costs like adverse-event-related medical care or long-term baseline medication in the patient’s home country between study visits? Or have you helped a patient to achieve such coverage in the patient’s home country?*
  • Rows
  • As a Sponsor, have you been asked by patients to cover the follow-up healthcare costs in the patient’s home country after participation in a Clinical Trial? Or have you helped a patient to achieve such coverage in the patient’s home country?*
  • Rows
  • Are you aware of any pre-requisites, minimal requirements, limitations and/or exclusion rules in your country concerning financial coverage of costs for patients from abroad participating in a Clinical Trial in that country?*
  • Please specify (multiple answers are possible)*
  • As a Sponsor, do you have/know about any specific procedure, infrastructure and/or recommendations to enable a patient, to participate in a Clinical Trial in another country?*
  • Please specify (multiple answers are possible)*

  • Personnal 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

  • Terms of Use and Data Protection Policies

    We respect your trust, and the protection of the personal data is important to us. Therefore, we act in accordance with the European General Data Protection Regulation (GDPR). By filling out this form you acknowledge that your personal data will be provided to EU-X-CT Core Management Team, EU-X-CT Members, and Task Force members carrying out the mapping exercise to identify and collect available contacts who can provide information on enabling cross-border access to clinical trials. The contact information may be shared with EFPIA Staff, but will not be given to any other third party and, 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 data privacy policy or 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 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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