While the clinical trials industry has been working vigorously to find ways to navigate through COVID-19-imposed challenges, our own experience also tells us that many investigators have been facing even harder times.
In order to evaluate the situation, OCT Clinical interviewed Karina Khidishyan, MD, an investigator at one of the largest oncology sites in the country, the FSBI Petrov Research Institute of Oncology of the Ministry of Health of Russia.
Karina, could you please comment on the general situation at your site? Do you get any help from Sponsors or CROs in terms of, for instance, taxis for patients?
[K.K.] Yes, we do. The companies we work with assist in arranging taxis for the following: patients and their relatives, for sending research materials,(this can also be via a courier); providing personal protective equipment. Also, sponsors hold a variety of lectures, webinars and meetings.
Talking about the patients themselves, do you provide home visits for them? And do you experience any challenges while doing that?
[K.K.] There is such an option, yes. At the beginning of the pandemic there was discussion about the implementation of such a practice. Our site has the right to conduct such visits from a legal point of view. However, in our case, many patients live in remote regions of Russia, that is, outside Moscow or Saint-Petersburg, therefore it is impossible for us to arrange home visits for 300 subjects on our own. So, what we did, together with all the teams, including sponsors, was to determine the optimal number of visits to the site, which, in the end, amounted to approximately 170 mandatory visits per month. Thus, all patients have the opportunity to continue with their treatment now.
Which risk-management measures were undertaken within your site to manage the situation with the pandemic?
[K.K.] We implemented necessary standard operating procedures (SOPs), moved all ongoing clinical trials to the clinical diagnostic department, minimized the time a patient stays at a preventive care facility, and provided personnel and patients with personal protective equipment. We ensure that patients are being tested for the COVID-19, that they arrange testing independently at their residence right before their visit to the site, and we thoroughly examine and interview all of the patients during visits to detect the coronavirus.
Do you employ third-party vendors to collect patients' bio samples at their homes?
[K.K.] It's a possibility, but has not been necessary yet. On the one hand, such measures ensure that patients continue receiving their treatment as safely and effectively as possible. On the other hand, there may be psychological issues for patients, since they can get worried about such a new arrangement.
Talking about ongoing studies, did you have to pass over any of them to another site because of the pandemic?
[K.K.] The probability of transferring a patient to another site will certainly increase if the epidemiological situation in the country gets worse. All these measures are primarily aimed at ensuring the safety of patients and maintaining the efficacy of the treatment. For example, we have had a case recently in which a patient underwent the procedures necessary for a visit to our institution at another research site in Moscow and then came to our site to go through therapy.
Has there been an increase in the number of missed visits by patients within ongoing trials?
[K.K.] We mitigate this risk by having reduced the number of patient visits. For instance, follow-up visits that do not require radial or laboratory diagnostics are conducted remotely by phone and video.
Do you employ IP delivery to patients' homes?
[K.K.] This option exists, but it has not been necessary yet.
Talking about eClinical solutions, have you been working with eClinical platforms for clinical trials? (ePRO, EDC)
[K.K.] Of course, the role of electronic questionnaires is important. For example, when assessing the quality of life of a patient. Given the situation with the pandemic, this tool greatly simplifies a doctor’s task of assessing a patient's condition and provides a more detailed status of a patient’s health.
How would you rate communication with sponsors or CROs within the last 2 months? Do you think remote monitoring is effective?
[K.K.] At the beginning we had some concerns that the quality of communication with CROs and sponsors might be compromised due to the situation with the pandemic and limited visits, but it never happened. We live in a time when digital technology can help us to get on with our work as effectively as possible. And due to the efficient and timely response of all the parties involved we managed to channel our communication quite successfully.
If there are any new studies about to start at your site, how do you manage processes such as site initiation, patient screening or even obtaining of ICFs?
[K.K.] We do it using online tools, courier services or remote signing of documents.
Does your site participate in ongoing patient recruitment at the moment?
[K.K.] We are getting on with our work and enrolling patients. The number of patients has slightly decreased. Now we can communicate with a patient and transfer informed consent forms for review using remote tools. Only if a patient makes the final decision on consenting to be included in a clinical trial is he or she invited to a face-to-face consultation. Screening procedures are carried out as quickly as possible in order to ensure patient safety.
Watch the video interview with Karina Khidishyan here.