Dear Nino

Many thanks for this information and step by step guide. We are having the clinical advisory group meeting today at 6 p.m. at the ministry and will convey this information to them. Would it be possible for you to join to explain details and address questions if any. We can have a video call for you to join.

Many thanks!
Tamar

Dear Tamar,

Thank you for your response and showing an interest.

As for the next steps, the MoH has to respond to the following 12 points:

1. MoH needs to obtain the necessary ethical and regulatory clearances at national level as soon as possible and sign the WHO standardized protocol (coverpage of the Study protocol enclosed for your easy access);
2. Once the protocol is approved and signed, the names of clinicians and principal investigators together with their emails and phone numbers are to be communicated to WHO (EURO  daram@who.int + HQ Lydonp@who.int ) with a copy to our WHO Country Office, if there is any;
3. This will allow to organize a rapid training on how to fill the online data form (taking around 5 minutes to fill in for each patient);
4. MoH/Clinicians need to clarify what medicines are available or need to be procured locally or supplied by WHO;
5. The National Drug Regulatory Authority (NRA) will need to issue an emergency authorization so medicines can be imported for those drugs that WHO will supply. If medicines are to be imported, an import permission should be issued as soon as possible;
6. WHO will send an official letter to MoH to start the Trial;
7. Once we know the import permit is available, WHO has agreements with the 5 manufacturers and will instruct them to ship the necessary medicines as soon as possible;
8. An address of where to send the drugs will be needed and MoH will be responsible for getting the medicines to the different hospitals / clinical trial sites;
9. For drugs that exist in country, these arms of the trial can move ahead. There is no need to wait for all drugs for all arms to be available;
10. Once patients come to hospital(s), they will be randomized according to the study protocol and put on standard of care or the trial arms. The data will be entered at admission and then at discharge or in case of death, the death and conditions which patient was in hospital;
11. The only paper work involved in the trial centers is the informed consent form (ICF). The rest is all electronic using the WHO system. MoH or WHO Country Office (if there is any) can help with translating the Informed Consent form to your national/local language (pages 5-8 of the enclosed SOPs and Appendixes);
12. WHO will process and analyze the data and submit findings to an executive committee. MoH will need to appoint 1 or 2 representatives to join the international steering committee what will have members from all countries conducting the trials. The steering committee will review the findings from the executive committee before anything is made public. It is through this process that decision will be made to continue or not with certain arms of the trial or add news one. This why it is called an adaptive RCT.

Thank you in advance.

Kind regards,

Nino

Dear Nino

Thanks a lot for forwarding these documents. ​Absolutely, we would be delighted with this opportunity. Please kindly advise on next steps. 

Tamar