Questions and answers about Feasibility Sweden

What is Feasibility Sweden?

Feasibility Sweden is Clinical Studies Sweden’s national service for feasibility requests to Swedish healthcare.

The service helps life science companies and academic researchers receive structured responses when planning and conducting clinical studies in Sweden.

Through Feasibility Sweden, you can:

• receive an early expert assessment of whether a study can be conducted in Sweden
• identify clinics and investigators with the capacity and interest to participate
  

Who can use Feasibility Sweden?

Feasibility Sweden can be used by life science companies and academic researchers planning clinical studies in Sweden.

The service is relevant if you want to explore whether a study can be conducted within Swedish healthcare or connect with clinics and investigators.

What does it cost to use Feasibility Sweden?

The service is free of charge for all users.

What types of studies and therapeutic areas can the service be used for?

Feasibility Sweden can be used for feasibility requests within all therapeutic areas and for different types of clinical studies.

The service can be used for, for example:

• clinical trials with medicinal products
• clinical studies with medical devices
• ATMP studies
• other clinical studies or interventions

Can I direct a Site Feasibility request to specific regions?

Yes. Site Feasibility requests can be directed to all of Sweden or to selected healthcare regions, hospitals or clinics.

What is the difference between a Country Feasibility and a Site Feasibility?

You should submit a Country Feasibility request when you want an overall expert assessment of whether a clinical study is feasible within Swedish healthcare.

You should submit a Site Feasibility request when you want to connect with clinics and investigators that may be relevant for participation in a clinical study. Site Feasibility is suitable when the study is sufficiently defined for recipients to assess whether they would like to receive more information or express interest.

Submit and follow requests

Why is a user profile needed?

A user profile is required to:

• access the forms
• submit and follow your feasibility requests
• view incoming responses

How do I create a user profile?

Create a user profile here.

Once your profile has been created, you can submit feasibility requests and follow your requests on My Pages.

Can I save a request as a draft?

You can save a request as a draft and continue at a later time. The request is also auto saved every fifteen minutes.

Where can I follow my feasibility request?

You can follow your feasibility requests on My Pages, which are only available when you are logged in. There you can view the status of ongoing requests, see incoming responses and get an overview of contacted hospitals and clinics.

What happens if information is missing from the request?

A feasibility request is reviewed as soon as it has been submitted. If any information is missing, the requester is contacted directly to complete the information.

How quickly will I receive a response?

Most requests receive their first response within the first 24 hours.

Response times vary depending on factors such as the type of request.

Site Feasibility requests often receive quick feedback, as they concern identifying interest and capacity to participate.

Country Feasibility requests may take slightly longer, as they involve a broader expert assessment of whether the study is feasible in Sweden.

When is Feasibility Sweden closed?

Feasibility Sweden is available all year round. You can submit and follow feasibility requests in the service at any time.

Requests are handled during regular office hours.

Response times may be affected during public holidays and vacation periods.

What does a Country Feasibility request answer?

A Country Feasibility request provides a consolidated expert assessment of whether a clinical study is feasible within Swedish healthcare.

The assessment is based on factors such as patient population, recruitment opportunities, study design and Swedish standard of care. It may, for example, indicate whether the patient population is present in Sweden, whether there are conditions for recruiting the desired number of patients and whether the study design is compatible with Swedish standard of care.

The experts responding to the feasibility request may also indicate whether there is interest in participating in the study.

All questions answered by the experts in the Early Feedback Form

What supporting information is needed for a Country Feasibility request?

For experts to make a relevant assessment, the Country Feasibility request needs to include basic information about the study, describing the study design, patient population and conditions for conduct. This may include:

• therapeutic area
• study phase or type of study
• investigational medicinal product, medical device or other intervention
• patient population and key inclusion and exclusion criteria
• specific requirements for clinic, equipment or expertise
• protocol synopsis or equivalent study information, if available

What is Early Feedback Form?

The Early Feedback Form is the standardised questionnaire completed by experts in a Country Feasibility request.

Read all questions included in the Early Feedback Form here.

Can I add my own questions or use my own questionnaire?

You can add individual questions to a Country Feasibility request if needed.

At the same time, Country Feasibility is based on standardised questions in the Early Feedback Form. These questions are designed to make the process faster, easier to manage and more comparable. Therefore, company-specific questionnaires should not be attached to the Country Feasibility request.

More detailed or company-specific questions can often be handled at a later stage with investigators or clinics that have expressed interest in the study.

What does a Site Feasibility request answer?

A Site Feasibility request provides responses from clinics and investigators that have reviewed the request.

The responses show whether there is interest and capacity to participate in the study. You also receive contact details for the recipients who have expressed interest.

Can I direct my request to specific regions or clinics?

You specify whether a Site Feasibility request should be directed to all of Sweden or to specific healthcare regions, hospitals or clinics.

How do I know which clinics have been contacted?

In Feasibility Sweden, you can see which hospitals or clinics have been contacted, which have expressed interest, which have declined participation and which have not responded. This gives you both contact with interested recipients and a clear overview of how the request has been distributed.

Do I receive contact details for clinics and investigators?

You receive contact details for the investigators or clinics that have expressed interest in the study. Contact details or other information about recipients are not shared without consent.

How quickly will I receive responses?

Many feasibility requests receive responses within a few days, and a large proportion receive their first response within 24 hours. We work to ensure that all requests are answered within the agreed timeframe.

Can I do anything to increase the possibility of receiving responses?

When you submit a feasibility request, you specify when the request needs to be answered. If you choose a longer timeframe, Swedish healthcare has better opportunities to handle the request, which may increase the possibility of receiving more and more complete responses.

For investigators and clinics

Can I receive feasibility requests?

If you are an investigator and would like to receive feasibility requests through Feasibility Sweden, please contact us at feasibility@kliniskastudier.se.

Do I have to respond to a feasibility request?

You do not need to respond, but your response is valuable.

Even a negative response provides companies and researchers with better input for planning clinical studies in Sweden.

Why is even a negative response important?

A negative response gives clearer information about interest and conditions within Swedish healthcare.

If you state why you decline, for example due to lack of time or resources, this also contributes to increased knowledge about the conditions for clinical studies in Sweden.

Confidentiality

Do confidentiality agreements need to be established?

For feasibility requests to Swedish healthcare, company-specific confidentiality agreements, such as Confidentiality Disclosure Agreements, CDAs, are normally not established. Instead, reference can be made to the confidentiality legislation that applies to Swedish healthcare.

Lif has published information on confidentiality protection in relation to public authorities under the Swedish Public Access to Information and Secrecy Act, as well as suggested standard wording for reference.

Guidance and standard wording for reference, Lif’s website. External link.

Technical support

Why can I not submit a request?

For security reasons, you are logged out after a period of inactivity. If you have been inactive for too long, you may need to log in again before the request can be submitted.

Keep the tab with your request open, open a new tab in the same browser and log in again. Then return to the request and submit it.

Who should I contact if I need help?

Contact Feasibility Sweden at feasibility@kliniskastudier.se if you have questions about the service or need help with a feasibility request.