Words by Jade Williams
Clinical trials must generate results that reflect how a drug will perform in the outside world, but this is not always achieved. There are multiple benefits of decentralised clinical trials, and there is potential for the results of these to align more closely with real-world outcomes
Once conducted almost exclusively in-person, with participants required to travel to and stay in clinical settings for lengthy amounts of time, COVID-19 forced conventional clinical trials to halt and put innovations in drug development on the back burner. This brought forward the push for new models, compelling pharmaceutical scientists to develop remote options.
Moving clinical trials from hospitals and into people’s homes is a long-overdue development that has been catalysed by the pandemic. While this is a challenging manoeuvre for the industry, it paves the way for drugs to be more regularly tested in patients’ natural environments, and for results to be a more accurate reflection of real-world outcomes. Although clinical trial developers have done their utmost to replicate real-world situations within their studies, this has not always been achieved.
In a panel discussion at ‘Reuters Events: Pharma 2021’, Victoria DiBiaso, Global Head, Patient Informed Development and Health Value Translation, Sanofi, notes that it is important for clinical trials to “mirror real-life conditions”. When a treatment is prescribed to be taken in the home setting, a patient will not be able to touch base with a healthcare professional as often, nor will educational support be as readily available. Conditions like this accurately depict the realities of the standard of care outside clinical environments, and technologies such as artificial intelligence and personal monitoring software allow scientists to replicate rigorous laboratory controls.
Furthermore, bringing trials into the home can greatly improve access for marginalised communities, who may not have been able to reach clinical environments, thus leaving them out of the patient pool and potentially unable to benefit from drugs that fit their needs. Also speaking at the Reuters event, Kate Wilson, Associate Director, Head of Health Equity, Global Clinical Operations, Biogen, states: “It is critical for clinical trial participants to accurately represent the populations that medicine is designed to treat; however, we know that many people are not well represented in clinical trials.” In support of this, a study released by the FDA in 2020 found that white and non-Hispanic Americans make up the majority of clinical trial participants in the USA, despite the Hispanic group accounting for 18.1% of Americans, according to Clinical Research Pathways.
Translate patient insights into actions that develop new healthcare solutions
This disparity in trial participation results in a lack of clarity for under-represented groups who tend to suffer from certain diseases more frequently than others. For example, diseases such as lupus are two to three times more common in women of colour than in white women. But that’s not all, decentralised trials also enable patients to enjoy the convenience of having drugs and trial materials delivered to their doors, without the need to spend long stints in hospitals.
While pharma has done well to develop decentralised trials, there are still improvements to be made. DiBiaso comments that pharma companies must “translate patient insights into actions that develop new healthcare solutions, with meaningful outcomes that address unmet need”. This unmet need can be satiated through working with patient groups to gain insight on what patients truly experience in the world outside clinical trials. Pharma companies must continue listening to patient insights to work through the remaining knots in real-world replication and truly represent the reality of care. DiBiaso comments that Sanofi is seeking advice on trials in 33 different countries to gather more than just the global view, digging deep into communities to truly reflect accurate patient outcomes.
Replicating a patient’s reality in clinical trials is something pharma companies must strive for in order to generate results that will accurately reflect how a drug will perform outside the lab. Convenience and access for patients must also continue to shine as a key marker of success of trials in the future. Progress has been made, but there is still work to be done toward true transformation; a goal that both pharma and patients will continue to march towards together.
This article will feature in GOLD 19 – to receive a copy of the magazine directly in your inbox on publication day (8 December 2021), click here.