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While key regulating bodies continue looking for strategies to manage the impact of the pandemic, there are certain regulatory implications that clinical trial leaders worldwide should be aware of. This is an interview with industry experts Natalya Eliseeva (Senior Regulatory Manager, OCT Clinical) and Tatiana Goruishkina (Registration Manager, OCT Clinical), who will shed light on the implications the current situation brings to the clinical trial world.
1. Natalya, we all know that key regulating bodies have been vigorously working on the responsive actions and strategy toward clinical research during the pandemic. FDA, EMA, MHRA, PMDA, ANVISA and other related entities have issued guidelines to assist the industry participants. What about Russia? Are there any instructions or guides released?
N.E.: I think the letter from the Russian Ministry of Health on March 20, 2020 should be considered as the primary local document relating to the issues regarding conducting clinical trials during the COVID-19 pandemic. The guide stresses that the safety of trial participants should always be at the forefront of all considerations and also includes recommendations on reducing social contact while conducting trials.
2. How do you think the FDA, WHO and MHRA’s recommendations and the changes they have introduced will affect Clinical Trial Application approval procedure in Russia and Eastern Europe?
N.E.: There have not yet been any changes introduced to the local regulatory documents managing the CTA approval process. To obtain approval for new clinical studies, we follow the official IND approval procedure and recommendations, our own Risk Management Plans and procedures, and common sense.
3. Do you think it is possible to accelerate CTA approval for COVID-19 drugs or vaccine trials in Russia?
N.E.: Yes, I think it is quite possible. Besides, there have already been several COVID-19 studies launched over the past two weeks with the approval obtained within a shorter time. This is clearly a case in which the Regulating Body should demonstrate more leniency, since they have shared interests in the overall success of the trials.
4. Patient safety is without doubt the number one priority, as always. How is it addressed in your region and have any new measures been introduced for additional protection of study participants?
N.E.: The MoH set of guidelines addressed this point, stressing that a considerable reduction of social interaction should be applied for the sake of all trial participants.
5. Tatiana, do you think the changes and guidelines introduced by the FDA, WHO and the MoH of Russia will affect marketing authorization procedures in Russia and the EAEU region overall?
T.G.: We should anticipate delays in finalizing the elavulation for the drugs that are in the middle of obtaining marketing authorization. Even though its duration is mandated by the Law, the length of time is measured in business days. Therefore, with the introduction of non-working days there will be postponements. Also, we should expect limited travel by the Ministry of Industry and Trade of the Russian Federation employees, which in turn will cause some delays in obtaining GMP-certifications and, as a result, marketing authorization.
6. Is it possible to establish a fast-track system for COVID-19 drugs and vaccines to obtain marketing authorization in Russia and the Eurasian Economic Union?
T.G.: Given the situation, that would be a fair and prudent solution. I think that the both fast-track and accelerated approval introduced by the regulating bodies will help bring such drugs and vaccines to market as quickly as possible to address the serious public health threat caused by the new coronavirus.
7. In its guidelines the Ministry of Health of Russia urges to switch to alternative monitoring methods, by introducing the practice of replacing in-person visits with telephone calls or virtual visits. Can you comment on its actual application in Russia? Your CRO?
N.E.: The industry players have been introducing remote monitoring into their standard procedures in accordance with the MoH’s recommendations. Naturally, our Clinical Team included these procedures in our Monitoring Plans to be implemented when necessary.
8. In case there is a considerable protocol deviation, what should the scenario for clinical trials look like?
N.E.: Actually, it all should go according to routine practice. All deviations are documented and addressed in the report. There will be corresponding deviations after the MoH's latest guidelines regarding the COVID-19 are introduced and followed. If there are any deviations detected at a site caused by a serious violation of the GMP or fraud, it will lead to the termination of clinical trials at that site. This should be followed by notifying regulating bodies, in the case of it being a serious deviation jeopardizing the safety of a trial and clinical data integrity.
9. How are such deviations and their causes documented?
N.E.: Everything is done according to the procedures applied in the trials. Normally, all deviations are documented in Monitoring Reports. Afterwards, they are entered into the Deviation Log and get highlighted in the Clinical Trial Report with the discussion on whether a patient is eligible for statistical analysis. Deviations, related to MoH’s recommendations on conducting trials during the pandemic, can be deemed acceptable should a CRO have planned ahead and introduced a remote monitoring practice.
Should there be substantial deviations (e.g. an ineligible patient), a CRA then reports the finding to a Project Manager and includes it into the Clinical Trial Report.
10. What additional measures have been taken to ensure the safety of the personnel involved in a clinical trial?
N.E.: The general recommendations of the regulating entities on reducing social contact and keeping physical distance also apply when ensuring the safety of clinical trial associates conducting monitoring visits and investigators.
11. What do you think the impact of the FDA and WHO Guidelines on the clinical trials market in Russia and the EAEU region will be?
N.E.: The role of guidelines is essential, as they bring additional structure and help all the parties concerned to respond accordingly. The overall situation caused by the pandemic, however, has been brutally affecting the clinical trial landscape worldwide, and Eastern Europe is not an exception. One of the major processes hit by the pandemic is, of course, enrollment, which is being placed on hold in many cases.. But we should all stay focused and deal with arising complications one thing at a time, because sooner or later this will be over and we will have to be able to resume our work as effectively as possible.
12. Finding the vaccine is at the top of the agenda today. Is there any progress in Russia? Is there any help from the government?
N.E.: Of course, the Government is assisting the vaccine research. As mentioned earlier, the acceleration measures for approval and authorization processes are being introduced. Also, Sberbank (the largest bank in the country) has been finalizing the terms with the Government on offering grants to Russian researchers working on COVID-19 vaccine and drugs. As for the development of the vaccine, the Prime Minister of Russia announced that at the moment 6 vaccines are getting ready for trials. Also, a number of studies for the COVID-19 treatment drugs have been launched, and among the drugs tested there is Mefloquine, Hydroxychloroquine and Colidavir.