Why is now the best time to go for digital solutions to save your trial?
The pharmaceutical industry and CROs have been struggling with a long list of challenges since the outbreak of Coronavirus (COVID-19), and the one topping the list is to ensure the continuity of trials. With the emerging hurdles of enrollment, study start-up, patient retention and site visits, the situation calls for alternative models to be employed by sponsors, such as using advanced technologies, which help the companies to shake off inertia and ensure the continuity of trials with minimal losses and the highest compliance. Moreover, in its recent emergency guidance, the FDA encourages trial sponsors to leverage on the technological solutions which can help to facilitate trials under the current circumstances and ensure their continuity.
Our Q&A is run today by the Head of Data Management, Anastasia Zaitseva, who will address the most pressing issues raised by sponsors recently:
1. How can we ensure the continuity of a trial and data capture during the pandemic?
Under these challenging circumstances, it is more essential than ever to consider eClinical solutions, especially those which can support remote site-patient interactions. For instance, ePRO (Electronic Patient-reported Outcome), enables remote collection of patient data which then goes directly into EDC. In the meantime, an investigator can track the data online and act accordingly. With Data MATRIX ePRO, data can be entered both on a sponsor-owned device as well as on a patient’s personal mobile device. The solution is designed with a focus on patient centricity and patient experience with a variety of useful interface features. Patients, for instance, do not need to memorize when they need to access the app or create reminders for it. All the notifications for filling out the questionnaires show up offline as well.
2. If there is a need for a speedy trial start-up (e.g.vaccine trials), should we go for paper or EDC?
While it might seem that with paper you can hope for a faster trial start-up, the reality shows the opposite. On average, EDC platforms allow sponsors to launch clinical trials within the shortest timelines, speeding up the start-up by up to 30% percent. With Data MATRIX EDC it is possible to launch a trial within 1.5-2 months. Additionally, the solution enables the quick processing and analysis of clinical data, with the guarantee of compliance, leanness and validity. This and the speed of incoming data will allow the investigators to make decisions within the shortest time, thus shortening the path from drug to patient.
3. What if there is a need to stop the screening process immediately?
Within our risk-mitigation action plan such a need arose in several projects, and in response to the issues, a special code was created for DBAs to be able to perform the task.
4. Is there a need to modify eCRFs?
Some of the eCRFs, that were not supposed to include information on additional lab tests, are now being modified to include the entry on Covid-19 tests.
5. Is Covid-19 coded as an adverse event?
Though we haven’t encountered such cases yet, Covid-19 positive cases will be coded as adverse eventsAQ, except when it is a Covid-19 trial.
6. With many CRAs now not being able to visit sites, it is impossible for data to go through the necessary SDV. Does it affect the data-cleaning process in any way? How can the problem be dealt with?
We clean unverified data as it can be helpful for CRAs during the on-site visits later. In addition to that, we recommend checking the validity of the documented protocol deviations and other information related to Covid-19.
If you have any additional questions or concerns regarding your trial, do not hesitate to contact our team at firstname.lastname@example.org. Your request will be processed with high priority. We would also like to remind you that we offer our EDC platform at zero cost for sponsors running novel coronavirus trials.