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Servier is committed to medicine without borders
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Why do certain patient populations respond better than others to a particular treatment? How can we adapt this type of genetic predisposition when developing medicine? Part of the answer to these questions lies in better integration of all categories of patients in the clinical trials that we conduct. Keep reading for the explanation.
Diversity in clinical trials: why is it important?
A more precise representation of clinical practice
An important aspect when initiating a clinical trial is to ensure that the sample is representative of the patient population affected by the disease in question. Recruiting patients from varied backgrounds makes it possible to refine the results in terms of effectiveness and safety of treatments based on the patient profile.
Reproducing the diversity of clinical practices during the clinical trial allows us to validate our scientific hypotheses and allows us to obtain more widely applicable results. The more varied the patient profiles, the richer and more complete our research and results.
Marta Garcia, Director of Patient R&D at Servier
Providing access to treatments to as wide a population as possible
For patients whose medical needs are unmet, access to new therapeutic treatments is a vital necessity. Geographic distribution, for example, presents a challenge both for patients affected by a rare disease and for research. New decentralized and hybrid trial models offer a way to expand access to clinical trials to include patients in remote areas; This also ensures that the patient sample is representative of the population of patients actually affected by the disease worldwide.
This way, patients from typically underrepresented populations can benefit from an treatment that could change their lives.
Conducting clinical trials on a global scale is essential to ensure the reliability and effectiveness of a medicine for all patients.
Our global geographic footprint, the high degree of expertise of our local teams and our new hybrid trial models enable us to improve our clinical developments every day, not only in the diversity of patients participating in our trials, but also in our understanding. local characteristics. This also allows us to build closer ties with the health professionals and investigative centers involved.
Marta Garcia, Director of Patient R&D at Servier
For Servier: How can we ensure the diversity of our clinical trials?
To ensure the diversity of our clinical trials, we rely on a practical action plan to pave the way for representative recruitment. According to Marta Garcia, one of Serviers' challenges is to broaden the scope of our recruitment for clinical trials.
Expanding access through decentralized trials
In France, it is estimated that more than 70% of patients live more than two hours from the investigative centers carrying out the trials.1 In a decentralized model, the patient has less need to travel. Their data can be collected remotely, automatically and in real time thanks to new technologies available.
For Servier, using this type of model is a way to include patients who would otherwise escape the scope of investigation centers. For healthcare professionals, this is a way to save time, since the data is analyzed as it is collected.
Adapt protocols to patients
Making clinical trial protocols more accessible to patients also provides greater transparency. To do this, we have simplified and deployed our protocols in all local languages so that each patient participating in a clinical trial can fully understand the issues.
We also cover all costs incurred during the clinical trial process.
100%
of our lay summaries are validated by patient representatives and translated into the local languages of all countries participating in the clinical trial.
Working with patient organizations
Very often, ongoing clinical trials are presented to patients by investigators.
In a scenario where patients are increasingly knowledgeable and taking an active role in their treatment journey, they may even become interested in or ask their doctor to participate in a clinical trial they have heard about.
How to publicize clinical trials? Patient organizations have a major role to play as spokespersons, because their actions reach a wider audience than those of a single prescriber.
![](https://i0.wp.com/servier.com/wp-content/uploads/2024/05/servier-diversity-clinical-trial.png?resize=740%2C493&ssl=1)
Diversity is also sought in real-world evidence studies
Since 2021, Servier has been conducting an ongoing epidemiological study with a sample of nearly 15,000 hypertensive patients, spread across around twenty countries.
This large-scale study clearly highlighted the low level of control of cardiovascular risk factors, the underestimation of cardiovascular risk by patients and the difficulty of applying clinical recommendations to all patient populations, in particular. particularly those that are least often represented in clinical trials. This also allowed us to take into account the impact of psychosocial factors on the management of hypertensive patients in current practice.
The added value of this approach is that we reach a very large sample of patients. The Group's global geographic reach as well as our patient-centered approach are real assets to successfully carry out this project. The key lies in our ability to adapt to patients' needs in terms of language, access to the questionnaire and, above all, understanding of the study.
Sabine Bayle, head of proof generation at Servier
[1] https://www.afcros.com/en/working-groups/decentralised-clinical-trials/ (accessed April 2024)
Sources 2/ https://servier.com/en/newsroom/diversity-and-clinical-trials-servier-is-committed-to-medicine-without-borders/ The mention sources can contact us to remove/changing this article |
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