Descentralized clinical studies
Is it a challenge imposed by the SARS-Cov-2 pandemic or an innovation that must be consolidated?
In August 2021, Inovatie Serviços em Saúde, in partnership with institutions that support the pharmaceutical market, held the Clinical Research Summit 20201. The event, 100% online, was an initiative reated to bring up-to-date information and promote debate on clinical research among professionals from the pharmaceutical market, the medical community and other researchers, bringing together speakers and topics of great relevance in the current context.
One of the topics discussed was the #Descentralized clinical studies: a challenge imposed by the SARS-Cov-2 pandemic or an innovation that must be consolidated?”, presented by Glauce Nunes, a pharmaceutical-biochemistry graduate from the University of São Paulo, executive director at ICON, in Strategic Solutions Division for Latin America. The professional is dedicated to developing strategic alliance programs with the pharmaceutical industry in Clinical Research and Medical Affairs.
Glauce began her presentation by commenting on the data from a survey carried out by med Data that showed that the Covid-19 pandemic reduced patient access to research centers by 80%. “The number of new studies dropped b y 50% between January and April 2020 and 60% of researchers reported a significant decrease in clinical research activities,” she noted.
The solution to reverse this situation was the adoption of tools that contributed to the decentralization of clinical studies, such as remote monitoring, videoconference visits and home blood collection, among others. “The pandemic has accelerated the virtualization of both consumer and research patient behavior, allowing for the decentralization of clinical trials.”
And many interventions seem to be here to stay. Several surveys have shown that patients and physicians view these new modalities of physician-patient interaction with positivity and satisfaction. Glauce presented data from a survey conducted by McKinsey Consulting that found that 98% of patients reported satisfaction with telemedicine and 72% of physicians reported a similar or better experience with remote engagement.
“Decentralized clinical studies are relevant because they allow for faster recruitment and faster delivery of innovative medicines, to those who need them. If patients are comfortable and engaged with these new practices, it will be our role, as clinical research professionals, to make the elements of decentralization viable and find ways to implement it in studies in the country, because patients are the end and the means of this process.”
Difference between decentralized, centralized and hybrid studies
Glauce explained what differentiates these three types of studies
- Decentralized: all procedures are conducted virtually, using digital technologies for patient monitoring and medication delivery.
- Centralized: traditional clinical studies carried out in research centers.
- Hybrids: in this modality, simpler procedures can be performed virtually, that is, they are decentralized and more complex procedures, such as the first randomization visit, cell therapy and magnetic resonance imaging, are performed in conventional research centers.
“We want clincal research to be seen as an alternative treatment. For this, we have to seek communication channels with patients and allow, to a certain degree, an inversion in the current recruitment model, with patients choosing research centers”, pointed out Glauce.
Focus on the patient journey.
Pharmaceutical companies and CROs (Contract Research Organizations) are investing efforts in the detailed study of the patient’s journey for each disease in order to better direct study towards investments towards rapid recruitment and high retention rates.
Another relevant aspect that she highlighted was the collaboration between service providers, CROs and the like in the development of solutions that make decentralized clinical trials viable.
As an example, she mentioned the possibility of developing integrated systems in which the patient is randomized in a study and obtains their consent through the system, which accesss to the study schedule, visits and test results on the same platform, in addition to access to telemedicine consultations and prescriptions. “When we think about patients’ access to clinical research, we’re not just referring to our presence in the patient’s home, but our integration into their journey.”
Glauce ended her presentation by commenting that there are indeed many challenges ahead, and many of them are being resolved along the way, through transparent conversations with regulatory agencies that are also experiencing this process of change. “Innovation goes through processes of prototyping and trial and error, and we in clinical research know that failure is part of the process.”