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Clinical Research world has been seriously affected by the COVID-19 pandemic. Leading experts and market leaders, with the guidance of the FDA and key regional regulators, have been putting their heads together to design the best strategy and response measures to anticipate the challenges the industry will most likely face in the near future.
This is an interview with OCT's Clinical Operations Director, Irina Petrova, with a CRO's perspective on the global pandemic.
Irina, what are the primary challenges the clinical trial industry faces at the moment?
[I.P.] The clinical trial industry is very much affected by limitations imposed by the COVID-19 pandemic. It will not be an exaggeration to say that every process has been challenged, from logistics and monitoring to study conduct at sites, which are the most vulnerable. CROs are trying to adjust their procedures to the rapidly changing situation. The main regulatory bodies, such as FDA, EMA and MHRA issued their guidance to help the pharmaceutical industry focus on the critical aspects which should be discussed and covered by mitigation and contingency plans for each particular study.
What is the best strategy for a CRO under the circumstances?
[I.P.] To prepare a detailed analysis of the impact of COVID-19 on every project, document the results of this analysis and set up an action plan accordingly; to continuously collect and analyze incoming information to be able to adjust the risk mitigation plan pro-actively depending on the situation in each country of operations; to focus on the protection of subjects' safety and data integrity; to ensure the safety of our own employees; to strictly abide by the local regulations on travel restrictions, remote work, and quarantine measures.
What measures have been taken at your CRO?
[I.P.] Our CRAs and then all in-house employees were set up to work remotely. This was preceded by a test day in anticipation of the upcoming home-based regimen for all employees. Project Managers have updated Monitoring Plans to include remote monitoring procedures, and Risk Management Plans were updated for every project. We have also factored in the risks related to travel limitations for CRAs, temporary site closures, inability of the patients to travel, courier companies' limitations, shortage of study supplies and other challenges. Together with the sponsors we have been developing strategies to respond to and address issues arising during the epidemic.
How can remote monitoring help save the situation?
[I.P.] In extreme situations when on-site activities must be reduced, remote monitoring focusing on the most important data for subject safety may be an appropriate alternative. It is also crucial to remember that once the situation is stabilized and is back to normal all the transitional activities such as remote monitoring should be properly followed-up to avoid any adverse effects. Also important is that it is not acceptable to share patients’ data and grant remote access to the electronic database of medical facilities to the Sponsor's representative, because of ethical considerations and sensitive data protection.
How does the situation affect the patients who have been enrolled and are receiving care within ongoing clinical trials?
[I.P.] Luckily, so far there have not been any restrictions reported for patients at any of our sites. However, with the course of the pandemic we have to be prepared and anticipate such turn of events. Moreover, even if the site is open for the patients, they may prefer to stay at home, especially if their disease does not require emergency treatment and can be postponed, which is absolutely understandable. Some patients may be missing visits because they contracted COVID-19. All these situations and possible solutions have been discussed in every study where we have patients enrolled and receiving treatment. Information letters have already been sent or are on their way to the sites now. The discussions involved not only project managers and CRAs but also the Sponsor, biostatisticians and medical experts. Again, regulatory guidelines mentioned earlier are very helpful in taking the right decisions.
Are house visits/siteless monitoring an option in Eastern Europe/ Russia?
[I.P.] Yes, not for every site but for many of the sites this is possible, and the investigators confirmed that they are prepared to visit study subjects at their homes. However, a lot will depend on the intensity of pandemic development on our territories. We all are perfectly aware of the situation in Italy and China, where all doctors work non-stop, having to stay at hospitals for many days, and the question is whether they will have time to perform such visits. So, to prevent significant protocol deviations in the vast majority of the studies, it was decided that enrollment would be put on hold and site initiations postponed.
If sites are closed: what is a prudent way for a CRO to behave?
[I.P.] As discussed earlier, all the data should be checked and processed remotely when possible, while visits should definitely be redesigned accordingly. It is also essential to keep our finger on the pulse and check for any changes within every site at least twice a week.
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