Why do certain patient populations respond better than others to a particular course of treatment? How can we adapt these sorts of genetic predispositions when developing medicine? One part of the answer to these questions can be found in better integration of all patient categories into the clinical trials we conduct. Read on for the explanation.
Diversity in clinical trials: Why is it important?
A more accurate representation of clinical practice
One important aspect when initiating a clinical trial is making sure that the sample group is representative of the patient population affected by the disease in question. Recruiting patients from a variety of backgrounds allows us to refine the results in terms of treatment efficacy and safety according to the patient profile.
“Reproducing the diversity of clinical practice over the course of the clinical trial lets us validate our scientific hypotheses and allows for more widely applicable results. The more varied the patient profiles, the richer and more comprehensive our research and results.”
Marta Garcia, Chief Patient Officer R&D at Servier
Providing access to experimental treatments for as broad a population as possible
For patients with unmet medical needs, access to new therapeutic treatments is a vital necessity. Geographic distribution, for example, presents a challenge for both the patients affected by a rare disease and research. New decentralized and hybridized trial models offer a way to broaden access to clinical trials to include patients located in remote areas; it also ensures that the patient sample group is representative of the patient population actually affected by the disease throughout the world.
In this way, patients from generally underrepresented populations can benefit from an experimental treatment that could be life-changing.
Conducting clinical trials on a global scale is key in assuring a medicine’s reliability and efficacy for all patients.
“Our global geographic footprint, local teams’ high degree of expertise, and our new hybridized trial models are what put us in a position to improve our clinical developments every day – improvements not only in the diversity of the patients in our trials, but also in our understanding of local characteristics. It likewise allows us to forge stronger ties with the health care professionals and investigator centers involved.”
Marta Garcia, Chief Patient Officer R&D at Servier
For Servier: How can we ensure diversity in our clinical trials?
To ensure diversity in our clinical trials, we rely on a practical action plan to clear the way for representative recruitment. According to Marta Garcia, “one of Servier’s challenges is broadening the scope of our recruitment for clinical trials.”
Broadening access via decentralized trials
In France, it is estimated that over 70% of patients live more than two hours away from the investigator centers conducting the trials.1 In a decentralized model, there is less need for the patient to travel. Their data can be collected remotely, automatically, and in real time by using newly-available technologies.
For Servier, using these types of models is a way to include patients who would otherwise be beyond the scope of investigator centers. For health care professionals, it is a way to save time, since data is analyzed as it is collected.
Adapting protocols to patients
Making the clinical trial protocols more accessible to patients also brings greater transparency. To that end, we have simplified and rolled out our protocols in all local languages so that each and every patient joining a clinical trial can properly understand the issues involved.
We also cover all the costs incurred as a result of the clinical trial process.
100%
of our lay summaries are validated by patient representatives and translated into the local languages of all the countries participating in the clinical trial.
Working with patient organizations
Very often, clinical trials being conducted are presented to patients by the investigators.
In a scenario where the patients are increasingly well-informed and playing an active role in their treatment journey, they may even take an interest in or ask their doctor about participating in a clinical trial that they have learned about.
How to raise awareness of clinical trials? Patient organizations have a major role to play as “spokespersons,” since their actions reach a broader audience than those of a single prescriber.
Diversity is also sought in real-world evidence studies
Since 2021, Servier has conducted an ongoing epidemiological study with a sample group of nearly 15,000 patients with hypertension, spread out across roughly 20 countries.
This large-scale study has allowed us to clearly demonstrate the low level of control over cardiovascular risk factors, the underestimation of cardiovascular risk by patients, and the difficulty of applying clinical recommendations to all patient populations, particularly those that are the least often represented in clinical trials. This has also allowed us to take into account the impact of psychosocial factors on the management of patients with hypertension in current practice.
“The added value of this approach is that we reach a very broad patient sample group. The global geographic reach of the Group, as well as our patient-focused approach, are real assets for successfully conducting this project. The key lies in our capacity to adapt to patients’ needs in terms of language, access to the questionnaire, and above all their understanding of the study.”
Sabine Bayle, Evidence Generation Lead at Servier
[1] https://www.afcros.com/en/working-groups/decentralised-clinical-trials/ (consulted in April 2024)