1) Who should I, as a representative of a pharmaceutical company/CRO, contact for assistance with feasibility?
You should write to the National Coordinator (DNK) by e-mailing: firstname.lastname@example.org. The National Coordinator will manage the feasibility process, whether for the purpose of providing an overview of potential sites for a potential trial or with regard to implementing an actual site feasibility enquiry including the completion of a questionnaire in connection with a specific clinical trial. If a Confidentiality Disclosure Agreement must be obtained then the National Coordinator will also manage this process.
2) Can't I simply just contact the sites I have already established cooperation with myself with regard to a feasibility enquiry?
No. The Danish Respiratory Research Network would like to ensure close cooperation between all respiratory medicine departments in Denmark with regard to implementing clinical trials. Therefore, the network has decided that all feasibility enquiries will be issued to and discussed among the entire network. If a sponsor has any special requests for sites that should participate in a given study, this will naturally be taken into account.
3) What information does the National Coordinator require?
This depends on the type of enquiry, but the more information the National Coordinator receives in connection with a feasibility enquiry the better the network sites will be able to assess the individual clinical trial, potential challenges and how many patients it could realistically be possible to recruit. It would therefore be helpful if as much information as possible is submitted concerning the trial, patient population and the drug that is to be researched. Also include information about planned timelines. If Confidentiality Disclosure Agreements are to be obtained, a copy of the agreement must also be provided. In the event that there is a very short deadline for a pre-feasibility enquiry, it would shorten the processing time if the National Coordinator was to receive blinded material that does not require a Confidentiality Disclosure Agreement.
4) In our company we have a database containing e-mail addresses for doctors, and we would normally issue feasibility enquiries in accordance with our SOPs via this system. How can this be reconciled with the feasibilities process in the Danish Respiratory Research Network?
We acknowledge that companies have specific processes. In this case we ask that you submit an e-mail to the National Coordinator, explaining that you are planning to issue a questionnaire via the database and the National Coordinator will notify the network that such an enquiry is on its way. Companies are encouraged to update any internal databases and ensure that questionnaires/surveys are submitted directly to the network members and not people to which the enquiry is not relevant. The National Coordinator will be happy to assist in the validation of the information added to the database.
5) How can we ensure that the process of obtaining signatures on the Confidentiality Disclosure Agreements is not delayed?
We ask that companies submit Confidentiality Disclosure Agreements to the National Coordinator who will encourage the regional legal consultants to review the declaration with the shortest possible turnaround time. Alternatively, the approved standard – Standard Confidentiality Disclosure Agreement for Clinical Trials – can be used. You can access the standard agreement here. The legal consultants working on behalf of the network and regions are currently discussing company specific templates with certain companies.
6) Sometimes as a CRO I only have a few days in which to respond to a sponsor with information as to whether a specific trial can run in Denmark. What should I do in this scenario?
We understand your situation and will do what we can to provide a quick response. Please ensure that you make us aware that there is a very short deadline for responses in your enquiry.
7) We are planning to run a trial in Denmark but we only require two sites. Will it be necessary to comply with the full process?
The Danish Respiratory Research Network would like to invite all network members to respond to a trial and therefore maintains that all feasibility enquiries must be submitted to the entire network. If there is a situation in which there are discrepancies between the number of qualified sites and the number of sites required, the steering committee will be able to identify the best solution in consultation with the company.
8) Some time after a feasibility enquiry the National Coordinator contacted me with some questions concerning the trial. What will this information be used for?
In order to continuously follow up on the work of the network and to make ongoing adjustments to processes and optimise cooperation with companies, the National Coordinator will continuously follow up on the feasibility enquiries that have been submitted to the network and therefore requests feedback from the companies in respect of the following questions:
• Is Denmark participating in the trial concerned?
• If no, why not?
• Which sites have been contacted?
• Which sites are participating?
• If your company excluded some sites, what was the reason?
• Challenges – Have there been any specific challenges associated with this trial?.