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

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?*

CRO / SponsorsInvestigator

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?*

YesNo

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?*

YesNo

Participants Information
If you have any comments on the questionnaire or the project, please leave a comment below:*

Personal Data
Would you be interested in follow-ups on this mapping exercise by the EU-X-CT?*

YesNo
Thank you for your interest. Please provide an email address where you can be contacted*

First NameLast Name
Organisation*
Email*
example@example.com
I agree to be contacted by EFGCP for other activities/surveys/events related to the EU-X-CT*

YesNo
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
Survey Confidentiality Agreement*

I agree to Terms of Use and Data Protection Policy
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
Should be Empty:

	0%	1-25%	26-50%	51-75%	76-100%
Phase I
Phase II
Phase III
Phase IV

	Not Applicable	Not Challenging	Somewhat Challenging	Challenging	Very Challenging
Not willing to trave with required frequency
Not feeling comfortable to live far away from study physician
Not feeling comfortable with living abroad
Insufficient coverage for travel of patient and/or caregiver

	0%	1-25%	26-50%	51-75%	75-100%
Patients living in the European Union
Patients living in Eastern Europe outside the EU
Other

	Not Related	Somewhat Related	Related	Heavily Related
Insurance coverage
Hospital admission

	Not Related	Somewhat Related	Related	Heavily Related
Obtaining patients’ clinical history
Accessing healthcare documents and data from the patient’s home country (country of residence)
Sharing documents and data with the patient’s treating physician (home based physician)
Challenges with the data formats (electronic/paper) of the information

The EU Cross-border Clinical Trials Multi-Stakeholders Initiative

Questions to People/Operational experts – INVESTIGATORS

Administrative and/or organizational procedure

Logistics

Language & Cultural

Questions to People/Operational experts – CRO / Sponsors

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?

Administrative and/or organizational procedure

Logistics

Language & Cultural

Participants Information

Personal Data

Terms of Use and Data Protection Policy

	Not Related	Somewhat Related	Related	Heavily Related
Import license for medication without marketing authorization in the EU
Import license for medication with marketing authorisation in any other EU country but not in the patient’s country of residence
Import license for authorised medication that is not reimbursed in the patient’s country of residence
Shipping trial medication to the patient’s home not allowed in the patient’s country of residence
Health Authority approval
Adequate amount of medication
Tracking system for medication
Other

	Not at all	Yes, but rarely	Yes, a few times	Yes, regularely	Yes, a lot
Cost of travel & accommodation
Required visit flexibility, e.g., due to need for titration/dose adjustment
Inability to keep follow-up appointments such as inability to travel or cost of accommodation

	Yes	No
Availability of accommodation in the vicinity of the trial site
Payment for the accommodation
Payment and/or accommodation of accompanying persons

	Yes	No
Cost coverage for the travels
Visa application
Organizational support for the patient
Organizational support for the accompanying person (caregiver)
Reluctance of local physician to cooperate with the clinical trial physicians/research coordinator

	Not needed at all	Sometimes needed	Needed	Mandatory
Translation of medical records
Translation of materials for patients (patient diaries, patients questionnaires, informed consent form)
Availability of interpreters
Other

	Never	Rarely	A few times	Regularely	A lot
Video conferencing (virtual calls)
Phone calls
Use of WhatsApp or other messaging platforms
Electronic consent (e-signature, DocuSign)
Applications

	Never	Rarely	A few times	Regularely	A lot
Cost of follow-up care
Reimbursement of care from public resources
Medical care/ required medication not available in patient's country of residence
Standard of care medication access
Collaboration and support from the patient's treating physician in their home country

	Never	Rarely	A few times	Regularely	A lot
Cost of follow-up care
Adverse management
Reimbursement of care from public resources
Medical care/ required medication not available in patient's country of residence
Standard of care medication access
Collaboration and support from the patient's treating physician in their home country

	Not Applicable	Not Challenging	Somewhat Challenging	Challenging	Very Challenging
The participant was not willing to travel often for the frequency required to take part in the trial study visits and follow ups
The participant did not feel comfortable living far away from the study physician during the trial
The participant did not feel comfortable living abroad
Insufficient financial coverage/re-imbursement for travel of the participant (patient and/or caregiver)