The coronavirus pandemic has virtually paralyzed much of the world. However, clinical trials cannot slow down, faced with the threat of delaying or preventing the progression of essential remedies and therapies.
Outsourcing-Pharma (OSP) recently spoke with Fareed Melhem (FM), senior vice president of Acorn AI Labs at Medidata, about how COVID-19 affects clinical studies and how pharmaceutical corporations and their partners want to adapt to keep up.
OSP: Your team has been monitoring the clinical trial landscape since the onset of the pandemic. Could you please share some of the key ways studies have changed since COVID-19 landed?
FM: We have noticed that a significant effect has an effect on clinical studies. With limited movements and blockages implemented around the world, patients who entered the studies fell from 50% to 80% according to the indication.
We also saw a significant accumulation of lost visits; with this, clinical trial groups want to reconsider their technique to trials. It starts with understanding the landscape and reading has an effect through examination and country by country.
We are also seeing a shift towards technologies that enable test virtualization; These include, for example, electronic consent solutions, telemedicine and access to knowledge for remote scales. We will also want to move to much more centralized monitoring and monitoring of trials to pleasantly manage patient protection and quality of knowledge, as monitors have not been physically on sites.
FM: As noted in the most recent article “COVID-19 and Clinical Trials: The Medidata Perspective” [page 18], the coVID-19 scenario is changing. This is due to the continued spread of the disease, other responses from the national and regional government, and the variation in detection and detection capabilities.
Taken together, this means that patients’ ability to participate in trials and scales at sites is evolving and presents demanding situations for corporations conducting trials around the world.
At Medidata and Acorn AI, we work to help our consumers navigate this pandemic, keep tests ongoing, patient and site safety, and obtain certain high-quality data.
OSP: How do test adjustments differ in geographic spaces, i.e. how do adjustments in geographic testing differ? AsiaPac to the United States and Europe?
FM: Test settings in geographic spaces differ for several reasons. First, geographical spaces have been affected to varying degrees, as have responses to the epidemic; This has had a variable that has an effect on the ability to recruit and enroll new patients, or to keep sites open.
In addition, regulatory rules vary from country to country, which has an effect on what corporations can do to modify their tests. This means that even in geographical areas such as Europe, the effect on trials differs, with the UK lagging behind other European countries in terms of recovery, for example.
Similarly, in the APAC region, China was the first country to suffer the primary effects of COVID-19 and has since been on an upward trajectory, while other countries such as Japan have been affected later and have only recently begun to recover from the impact.
OSP: Tell us about trends in patient recruitment and retention: how has this domain been replaced since the start of the pandemic?
FM: Given the demanding situations of the pandemic, it has become much more difficult for new patients to enter studies and make visits. Globally, we found that the highest negative has an effect on the ability of new patients to participate in trials in April; Since then, we have noticed a steady improvement in the target.
However, this has an effect on varying significantly across the geographic region and also through the healing domain (AT). For example, oncology was the least affected AT: we discovered a minimum of about 40% in the number of new patients who entered oncology screening sites in April, compared to the first part of 2019.
This is higher particularly in June, with an average number of new patients 10% higher entering test sites in June to the first part of 2019; This is likely due to the accumulation of patients as more sites are reopened. Other AT Haves recovered from April lows, but are still acting particularly worse than in the first part of 2019.
OSP: Please have an effect on other technologies in clinical trials.
FM: We describe 4 main spaces in which generation can have a significant positive effect on clinical trials in our white paper, “COVID-19 and Clinical Trials: The Perspective of Medidata”:
OSP: If you can take a look at your crystal ball, look at the long term and determine how you think the clinical trial landscape will be different in the short and/or long term remote.
FM: Clinical trials will continue to adapt to focus more on the patient and reduce the burden on patients and sites so that studies and clinical progress can continue, even in the case of a global pandemic. The pandemic has accelerated the speed of replacement and adoption of technologies that have been around for several years, and Medidata hopes this will continue in the future.
OSP: Similarly, what accommodations have an effect on the pandemic that can simply control that groups surrender once the virus is under control, and what do you think?
FM: This pandemic is likely to continue to have a direct effect on the industry at least for the next year and maybe more. Medidata believes that many of today’s investments in generation are likely to last some time.
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