How the way of working in Clinical Trials has changed due of Covid?

We invited two CRAs Alba Hernandis from Experior and Agnieszka Frankowska from Clinscience to discuss how Covid impacted their daily work. A retrospective on Covid and how it accelerated the implementation of technology.  The Pandemic has changed the way we are working. And we find ourselves in a scenario where remote work seems to stay, what will it be like in the future?

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How did you manage your regular work before the COVID-19 pandemic and how are you doing right now? 

Alba: Before the COVID-19 pandemic the CRA work was most likely to be 90% presential however due to all this situation this has changed significantly. Sponsors, Sites, CROs, Competent Authorities, etc.  have had to adapt to the situation very quickly to continue performing our work as efficient as possible remotely and to comply with the deadlines and milestones. We all had to learn, and the rights of the patients have to be protected and in remote means is more difficult to ensure it. Each country has adopted their own measures, so we had to follow them in order to continue with the regular monitoring, however I think it is still a lot to do if the tendency is to decentralize the tasks of the CRA.

Agnieszka: Before the pandemic, the planned monitoring visits somehow imposed work organization in advance. Currently, preparation for the visit relies more on the initial analysis of data sent by the Site (CRF, Logs) in order to be able to predict possible areas for discussion before the meeting. In conditions of limited opportunities for meeting with members of research teams, constant, regular communication with the Sites has become much more important.

 Talking about the duality of remote and on-site work, what is done now on-site and what is done remotely?

Agnieszka: Many study documents (without personal patient data) are submitted to the monitor prior to the visit for verification (i.e. study logs, checklist etc.). Before the pandemic, the sites preferred to discuss and solve issues during the meeting; now, there is a better understanding of remote cooperation. This saves time spent on visiting the Site and allows to better plan the meeting and focus on the most important issues. On-site visits are intended to the SDV & ICF review, administrative & organizational issues are discussed and resolved remotely.

Alba: As said before, it is still a lot to do for decentralize the CRA work, Covid situation has help us to see that presentiality is not the only way to do monitoring activities. However as soon as we have been able to resume the onsite activities, this has been done again.

• Talking about what has been done remotely and on-site, for example the revision of Informed Consent Forms (ICF) and Investigator File I think are two things that still require on-site visits.
• Revision of the medical notes – in some countries this can be done remotely by accessing to the medical chart of the hospital, this is something that in my opinion will be the future but it is something that should be implemented by the hospital, other options that is being done is to anonymize the medical notes and upload them to the eCRF or send them by email so the CRA can review this data – to do so, legislation should be followed, EC should be informed according to the guidelines and the patients should also be informed about this remote revision and if required ICF should be signed.
• Trainings to the team can also be done remotely and we have done several Site Initiation Visits remotely.  
• Pharmacy forms – in most of the pharmacies the documentation is kept electronically and is send by email or through a platform to the CRA (so no need to do an on-site visit to the pharmacy).

Regarding the tools used, I would like to know if from your perspective, the environment of Clinical Trials has been able to adapt the technology to this new situation. 

Alba: I think we are still a bit far away; we have adapted to the situation in order to continue our work, however there are several tools that would be useful for example, electronic ICFs.

Agnieszka: In my opinion, the Clinical Research community (Sponsors, CRO) was technically ready to adapt the technology to this situation, but the pandemic highlighted the need to adjust existing law in order to legally implement it. This is a very important issue for the Sites which very often, despite their willingness to cooperate, had concerns to what extent they could use the new tools so as not to infringe patients’ rights to maintain adequate data protection.

Could you tell us, in your case, what technology do, or did you use or had to implement to adapt to this new situation?

Alba: Teleconferences with the site has been the most used for the remote monitoring here. We have implemented other ad hoc systems, always reviewing the instructions of the country to be in line with the legislation and the guidelines of the Competent Authorities.

Agnieszka: The tools used so far in internal communication (training platforms, teleconferences, online training) have been used to a greater extent than before in cooperation with Sites; also, Sites use modern tools much more willingly. 

In the other hand, talking about the access to the teams who you usually work with. How this have changed and how has been the role of technology for you in this situation?

Agnieszka: At the beginning of the pandemic, the access to the teams was very limited. In the following months, research teams approached the remote form of communication & technologies more and more boldly, also experimenting with new tools for communicating with patients. Circumstances have to some extent forced study teams to adapt new technologies to their routine activities, but it seems they want them to stay for longer. In most of cases it is now much more convenient to cooperate with sites in areas that were previously perceived in more traditional ways, (i.e. remote monitoring visits, including SIVs and COVs). 

Alba: Teleconferences have been our best friend and create tech solutions ad hoc, one of the best ways to review documents, data, or any other study form.

Seeing how your work was before and how it is now, how do you think your work will be in the future?

Alba: think this will help to push our work to be more efficient by doing risk base monitoring and only perform on-site visits for the riskiest data or documentation that require an on-site review and the rest of data/documentation to be reviewed remotely.

However, to do so, not only the CRAs (CROs, Sponsor) but also the sites should also be part of the change and should adapt their way of work, because it is still difficult in some hospitals where the study coordinators are not available remotely and ask the CRA to be on site.

Agnieszka: In my opinion, in the future, clinical trial management will be more RBM based, with fewer on-site visits. Using new technologies to record source data sent in real time via your phone or tablet can reduce the need for traditional SDV on your site. I also suppose that telemedicine tools will be used to a greater extent in routine patient visits.

Looking to our nearest future, do you think the Industry is ready for decentralized CT? And why?

Agnieszka: I think that the DCT is the future revolution of clinical trials, but this revolution requires cooperation and integration of different systems of data sharing. The huge role of the Industry is to educate medical teams and patients about benefits of decentralized CT.

Alba: I think it is not ready at all, we are on the way but there is still a lot of work to do from all the perspectives, because I think there are several parts of our work that still require on-site visits and we all have to change our minds and be in the same direction, and of course the technology could help us.

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Experior, with recognized experience and a staff that stands out for its high qualifications, covers all fields related to clinical research, from phase I to phase IV. Its service is flexible and adapts to each client and each project.
Experior ‘s corporate culture facilitates the simplification of processes and the reduction of time, which results in greater customer satisfaction. In addition to Experior’s network of offices in the main cities, the company also has a team of local CRAs.