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What was the impact of the pandemic on clinical studies?
The Covid-19 pandemic had, among its many effects on society, an important impact on the conduct of clinical trials, with several studies being suspended or even cancelled. In addition, fear of contamination led several centers to restrict people's access.
In 2021, LACOG conducted a study with 350 representatives of research programs in Latin American institutions to assess the impact of the pandemic on clinical trials in oncology.
Ninety research centers participated in the study, 70 of which located in Brazil. Most had confirmed Covid-19 cases at the institution (n = 57; 63%). One of the important findings was that part of the research was interrupted, in 49% of the cases by decision of the sponsor. The survey also revealed that in 28% of the institutions there was a change in the screening processes, with the prioritization of patients with the greatest potential to benefit from the therapies (severity of the disease).
Clinical trial routine was affected by appointment cancellations, reduced patient attendance, reduced availability of other specialties, or changes in follow-up processes. The survey also showed that 57% of centers adopted telemedicine to assess the patient; 74% put the research team in a home office and 77% had remote monitoring.
The use of digital platforms
The use of digital platforms to carry out clinical research has been especially discussed in times of a pandemic. An event held by the Pharmaceutical Products Industry Union (Sindusfarma), which aimed to discuss the disruptive moment of clinical research resulting from the impacts of the pandemic, pointed out that the introduction of digital platforms was accelerated to carry out various activities related to clinical studies, such as telemedicine, monitoring, signing of contracts and terms of consent, among others.
Research shows that there has been an approximate increase from 9% to 57% between January and May 2020 in surveys conducted remotely. Making phone calls and teleconsultations, and even sending medication and monitoring equipment by mail, were some of the actions used as new approaches within the pandemic.
On the other hand, it is also necessary to question to what extent the data obtained in systems like this are valid, since the collection of information may not be as rigorous as a face-to-face survey. Therefore, scholars believe that the future lies in a hybrid model of clinical trials.
Veeva Insights; an American cloud computing company focused on pharmaceutical and life science applications; on health in 2022, show that predictions which the pharmaceutical industry would adopt an entirely virtual model, in which study sites would become less relevant, have already been proven invalid.
The industry seems to be moving more and more towards a hybrid model of clinical trial execution with some decentralized elements. Study sites and the researcher will continue to play a vital role in patient engagement and retention. As more clinical data is collected electronically, studies will be better managed and new therapies will be discovered more quickly.
The positive data of the pandemic in clinical studies
According to data from the Brazilian National Health Surveillance Agency (Anvisa), Brazilian participation in clinical studies grew during the pandemic. Counting the surveys between phases I to III, in 2018 there were 163 studies in the country; in 2019 there were 202; and 259 in 2020. In 2021, the number dropped from the previous year, but still remained at a higher level than pre-pandemic years: there were 231 studies.
The percentage of studies in early stages increased from 27% in 2018, and 25% in 2019, to 40% in 2020. In 2021, the percentage of trials in the early stages remained higher, at 34%. The numbers show an increasing trend in studies in earlier phases, which may indicate an expansion of clinical research in the country.
In addition, to adapt to the demands imposed by the pandemic for carrying out studies and approving vaccines and medicines, Anvisa issued a series of instruments to adapt the regulatory framework to the pandemic scenario and provide faster responses. Now, the Agency is studying and preparing to ensure that these advances become a legacy, in order to implement the processes of ethical and regulatory evaluation in a more agile way, making Brazil a more competitive country when it comes to clinical research and attracting the attention of scientific communities.
Revista Hospitais Brasil