Elligo, Whyze Health partner to expand reach to European patients
Elligo Health Research has announced a new partnership with Ireland-based Whyze Health, a digital platform aimed at unifying research, healthcare, and patient data. The partnership reportedly will work to give patients increased control over their healthcare data; the companies also are forming a European Medical Advisory Committee to empower patients and doctors, and increase access to trials.
To find out more about the collaboration and the aims of its partners, Outsourcing-Pharma spoke with two experts:
- Frances Abeton, CEO of Whyze Health
- Christian Burns, president of Elligo International
OSP: Could you please share your thoughts on why increasing patient awareness of trial opportunities has historically been challenging?
FA: Multiple reasons, including a long-standing mistrust of clinical research because of past medical experimentation in some communities. This mistrust is warranted in many ways, thanks to horrific examples such as the Tuskegee experiments. There is a need for general education on the importance and safety of well-conducted, ethically approved clinical studies in the quest to develop effective new therapies in medicine.
CB: Communities can be extremely close-knit; members tend to stay within the same areas, go to the same physicians, and get their information from the same places, such as church, a community center, or through a friend. As clinical research is often confined to large teaching institutions, smaller community practices are not asked to participate in research, therefore leaving out the people in their close-knit community. If we are not reaching these physicians in local hospitals and community practices, their patients will never know about a study.
OSP: Then why are local healthcare providers a suitable pathway to trial participation?
FA: Community health providers, though lacking in trial-based resources such as insurance coverage, data management, dedicated research nursing staff, and appropriate IT support, are often high-volume treatment centers with highly skilled practitioners. They have plenty of skill and appreciation for the merits of trial participation.
What stands in their way is having the financial, operational, and technical support for such programs in the “real world.” Unlocking local healthcare providers as a suitable pathway to trial participation is very possible, but it does require a cultural shift, not only among patients, but also among hospital CEOs, caregivers, and insurance companies.
CB: Local healthcare providers are a suitable pathway to trial participation because drugs and devices in testing should represent the market in which they will be approved for. If there are gaps in communities where groups aren’t represented heavily, we may not have an accurate test for approval.
To get access to all patients, you need to consider the representation of all population groups that may have the disease/indication and identify the route to clinical trial education which may have differences for each of them. To penetrate most markets, practice and hospital physicians need to have informative study information to educate their populations.
OSP: Can you share any insight into how the European clinical research environment compares to the US — what challenges and demographics might be similar, and how might they be different?
FA: There are significant similarities between the US and Europe, warranting a joint approach to the problem of trial participation. Some structural differences exist in the way healthcare is purchased and governed between the US and EU, as a mostly market-driven, private approach pertains in the US while the EU has a mixed public and private delivery system.
However, patients are patients in both systems, and care pathways are now global, thanks to much wider cooperation across the world. There is no inherent reason there should not be a unified approach here, which is why this collaboration (Elligo/Whyze Health) is welcome.
CB: There are similarities and several fundamental differences in trial participation. Enormous language, cultural, political, and socioeconomic differences exist in many of the countries. Every country has a unique set of regulatory bodies responsible for clinical trial approval. Because the institutional review boards (IRBs) and ethics committees in each country differ significantly, achieving harmonized ethical review practices in global clinical trials is particularly challenging.
There is light at the end of the tunnel, however, as the EU implemented a centralized governing board to streamline clinical trial review and approvals. Just like the committee penetration in the US where Spanish and English are heavily considered in markets, multinational clinical trials have a more significant impact on the language during the recruitment process. Not just translations, but understanding stigmas, market, and how important the language is in the recruitment process. Informed consent procedures require that written consent be translated into the patient’s native language and any unique cultural aspects be considered.
Companies that specialize in global patient-recruitment strategies, such as Elligo, have established the need for culturally adapted methods to facilitate subject enrollment and ensure that ethical standards are maintained.