Over the last few years, patient centricity has moved from buzzword to an imperative. Sponsors are now increasingly willing to offer a patient centric approach to studies. However, there remains some confusion over what this means and how to implement it. In this article Cromos Pharma looks at some of the strategies that can be employed to promote patient centricity.
The roots of patient centric clinical research come from the patient advocacy movement. For several years, individual patients and representative groups have argued for greater consideration and protection of patients in the drug development process. Put simply patient centricity means putting the patient at the heart of clinical research from outset to endpoint. This means patient involvement in study design, including patient perspectives on location, monitoring and evaluation. It means creating opportunities for meaningful engagement throughout the clinical trial process for patients and reducing the burden on patients and their caregivers.
The benefits of adopting a patient centric approach are numerous and varied. For the patient it creates as sense of ownership and involvement in clinical research rather than being a “guinea pig”[i]. It may also reduce the burden on patient participants in terms of travel and time. For the sponsor adopting a patient centric approach can help increase patient recruitment and retention and improve data quality. Meaningful engagement with patient groups can also promote greater diversity in studies attracting hard to reach patient populations[ii].
A 2020 report by Deloitte identified four pillars that should form the foundation for patient centric clinical research:
The COVID-19 pandemic resulted in an acceleration of the trend towards decentralized clinical trials and remote monitoring as patients were unable to travel to study sites. Undoubtedly, leveraging digital technologies is a vital part of delivering on the promise of patient centricity. These tools allow us to bring the clinical trial directly to the patient and play an important part in reducing the burden of participation. Digital technologies can also be used to improve the patient experience in other ways for example simplifying and making the informed consent process better.
For Cromos Pharma, patients have always been at the centre of what we do and how we do it. We understand the important role the clinical research organization (CRO) plays in promoting patent centricity in clinical trials. As an international CRO, patient centric clinical research involves creating meaningful engagement with patients throughout the entire trial from design to execution.
We aim to understand what the patient wants before, during and after the trial. We can address key challenges around patient recruitment by putting forward methods to identify, engage and support patients. By understanding our patients, we can assess how best to reduce the burden of participation e.g., how many site visits are preferrable, how far are patients willing to travel and what do they expect from their experience. We can identify patient-specific concerns that have an impact on recruitment, compliance, and retention. Here are some of the key elements we use to inform our approach:
Cromos Pharma is delighted to be taking part in the upcoming DIA Europe conference (15 – 19 March 2021) and BIO-Europe Spring (22-25 March 2021).
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Are you a sponsor seeking to conduct clinical trials in the European Union but do not have a registered office in the European Economic Area? If so, in order to comply with the European Union Clinical Trial Directive, you are required to work with a Legal Representative registered in an EEA country.
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If you missed the live webinar “Where in the world should I locate my pivotal clinical trial?” you can now watch the recording by clicking here. The webinar hosted by the Society of Physician Entrepreneurs (SoPE) and Workforce Genetics features Cromos Pharma's CEO Vlad Bogin, M.D, FACP.