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We at Clariness strongly believe that it is crucial to better understand what’s important to patients and their needs during these challenging times. That’s why we conducted a survey in which we asked more than 17,000 patients from 21 countries a range questions across several topics, including a subgroup of people who are currently enrolled in a clinical trial on whether their participation is somehow affected by the pandemic.
In this post we discuss some insights on this topic based on the data. The underlying data can be downloaded in form of an infographic here for free.
Depending on where the trial of each of the 752 survey participants is conducted (whether it’s in a hospital, at a doctor’s practice or in a dedicated research centre), we found discrepancies between the different locations. In one location type, nearly half said their participation in a trial is somehow affected. Obviously, there is a huge divergence in how these different location types operate: for example, dedicated research centres need to worry less about a large patient influx that is unrelated to the trials themselves. This may alleviate the burden of complicated hygienic protocols and staff rotas in coordination with physical separation of the intensive care unit COVID-19 patients.
We found large discrepancies between different regions when looking at the survey participant data clustered by geographical area (largely as continents). In one region in particular, trial participation was very much affected. In fact, nearly two thirds of trial participants in that region said that they are either “very worried” or “extremely worried” about COVID-19 exposure, compared with less than a quarter in most other regions.
The hurdles and challenges that a given sponsor or site encounters can vary a lot by region, which could explain these discrepancies. Regional differences – including (but not limited to) in the healthcare and political systems, social security status, income, and the culture – should be considered as much as possible to ensure a smooth execution of a globally conducted trial.
There were also large and unexpected discrepancies in answers between the different age groups, especially as the age gap between the groups widens. The trend we observed was that the older the person, the less likely it was that they said their trial participation has been affected. These findings were particularly surprising considering the timing of collecting the survey data: summer 2020. A long time before a single company had a complete set of phase-III vaccine trial data. Way before the elderly were the first to be offered the jab.
Vaccine rollout efforts vary massively from country to country, as widely reported in the media. Even wealthy countries such as many in the European Union are lacking behind in their vaccination efforts, due to a multitude reasons such as production and supply chain shortages, political indecisiveness, and vaccine hesitancy. Most of us have realised that we won’t go back to “normal” for “a while”. Hence, for the coming months (and in some areas likely years) it’s important to take patient worries into account. This includes measures that sites can take to reduce COVID-19 exposure of participants, as well as a clear communication strategy of these measures to potential participants.
If you are interested in more insights regarding patient wellbeing during the pandemic and how Clariness can support your clinical trial, please don’t hesitate to reach out to:
Dr. Andree Beckerling | CEO
Mobile: +49 (0) 173 510 40 13
The CLARINESS Team is here to help YOU overcome the challenges in conducting clinical trials during these extraordinary times