How our global Clinical Enrolment Managers (CEMs) give clinical trial sites the local touch
At Innovative Trials, we pride ourselves on supporting local clinical trial sites to perform at their best, no matter where in the world they are based. In this blog, Global Site Optimization Specialist Manager Sandra Adeniji, who manages our network of Clinical Enrolment Managers (CEMs), explains their vital role in providing local site optimization and community engagement services to support patient recruitment in major trials.
With the rise of globalization, the world has never been so connected. We are able to interact and work with people tens of thousands of miles away and across multiple time zones. Not only does this bring opportunities for businesses to perform on a global stage but it supports clinical research too.
During the drug development process it is crucial that potential treatments undergo rigorous clinical trials to investigate their safety and efficacy. Trials should therefore involve large numbers of patients, ideally from diverse backgrounds, to ensure robust data. While this might sound simple it is not always straightforward, which is why multiple sites established across the world is a major consideration for many funders.
A recent example of this is the Phase III clinical trial for the Pfizer-BioNtech COVID-19 vaccine. More than 150 sites were established across the world, in Argentina, Brazil, Germany, Turkey, South Africa and the United States. More than 40,000 participants were involved in total, including those from a diverse range of ages and ethnic backgrounds.
Of course, recruiting and retaining clinical trial participants is not as simple as this example makes it sound. Understanding the local environment and culture in each country where sites are based is key to successful patient recruitment and retention.
Our Clinical Enrolment Managers: the local touch for global trials
As a company based in the UK, a key element of our success is our local presence in 60 countries. We have a network of around 100 CEMs based in these countries. Each one speaks the local language – amounting to 42 languages in total – and has extensive knowledge of their local landscape of clinical trials. They all have varying backgrounds – some are medical doctors or have a specialism in a specific therapeutic area – but the one thing they all have in common is clinical research expertise. Their knowledge is vast, with an average of 16 years’ clinical experience in 48 therapeutic areas. It’s my job to liaise with each of them and coordinate their activity as we can have managers working on different projects at any one time.
Our CEMs allow us to provide local site optimization and community engagement services, no matter where clinical trial sites are based. It’s important to us that they are assigned to studies in their local region to ensure clinical knowledge of the local landscape. We pride ourselves on providing sites with a personalised service, including little things like speaking to clinical research staff in their local language, and do our best to match our CEMs with studies associated with their clinical area of expertise. Again, this helps to provide the best possible experience and a tailored approach for the sites engaged in patient recruitment for our clients and sponsors.
Bespoke support for clinical trial sites
The strength of a ‘local’ approach is the ability to create bespoke strategies for site optimization and patient recruitment – what is effective for a site in the United States may not be a useful suggestion for a site in Romania.
Our CEMs support sites in a number of ways. We develop strategies around site specific barriers during regular contact with the sites, either remotely or in person. CEM calls aim to identify patient recruitment challenges, the ideal strategy for patient recruitment and provide support in implementing such strategies at a site level. Other tasks may involve working on-site to clear a data backlog or reviewing patient databases.
By being based locally, each of our CEMs are able to develop appropriate community engagement strategies for successful clinical trial patient recruitment. This can include:
identifying locations that potential patients might visit regularly and work with associates to distribute educational materials and talk about the study in those areas and establishments
creating plans to engage and work with local healthcare providers, including pharmacies and community physicians
advising site staff on how to talk to patients for optimum engagement and retention
But site support and clinical trial patient recruitment is not the sole responsibility of our CEMs. They are supported by our central HQ team, which facilitates knowledge-sharing between sites – an important aspect, especially for trials with multiple sites in several countries. Our central team also supports by creating appropriate study materials for healthcare professionals and patients and running targeted digital campaigns to help increase study awareness, traffic to the study’s website and accelerate patient recruitment.
Globalization may be making it easier for the life science sector to run clinical trials across multiple sites and numerous countries, but local strategies are still very much a necessity for successful clinical research.
Contact us to find out how we can support your clinical trial needs.