Bridging Patient Support Gaps While Navigating Global Regulations

Craig Popovich, Associate Director, Implementation CIPP/E, Greenphire

Solving site and sponsor clinical trial pain points with technology is hardly a new concept, but the constantly evolving nature of global regulations and technological advancements means that this topic will always remain relevant. In order to stay ahead of the game, industry decision-makers must identify and understand potential gaps and proactively seek out solutions to these challenges.

The patient-centricity movement is in full swing around the globe, with lots of positive momentum aimed at easing the clinical trial participant experience and driving study enrollment and retention. Pair that with new and expanding industry-impacting regulations and heightened focus on compliance (e.g., data collection and storage, environmental controls, taxation, and payment regulations) and it’s clear that sites and sponsors have quite a set of challenges to contend with when it comes to optimizing their trials.

Nowhere is this clearer than on the international stage, where global patient payments exist at the intersection of clinical trial regulations, data privacy regulations, and banking regulations. Sponsors conducting international trials can easily find themselves in a quandary navigating the distinct legalities and processes across multiple nations for a single trial—an effort that is necessary but one that is extremely time consuming and fraught with unexpected hurdles, from language barriers and data collection and storage policies to payment modalities and types of allowable payments. In short, when conducting diverse clinical trials inclusive of populations across the globe, it’s paramount to ensure this is accomplished in a compliant manner.

Historical patient payment challenges

When we look at where the challenge lies historically, it’s helpful to think in simple terms: A sponsor or contract research organization (CRO) wants to get a payment to an individual. Unfortunately, that’s where simplicity ends. That sponsor is not just making a payment to a person; they’re making a payment to a clinical trial participant and/or their family—and what does that mean?

What kind of money transfers are legal in the participant’s country of residence? You need data from the eventual recipient in order to pay them —maybe data from the participant and their caregiver. Where is that data going when it’s being collected? Does it legally need to stay within the country? What safeguards need to be put in place?

Then there’s the clinical trial aspect. Let’s take France, for example. Clinical trial regulations state that a stipend or compensation for lost wages can’t be paid directly to a participant, but it can be paid to their caregiver. In Italy, there are regulations against stipends and support for travel under a certain distance. There are many nuances for every country.

So, where do trial teams go to get the answers? They often rely on internal departments (e.g., compliance), where complex legal and regulatory knowledge is shared, but due to continual changes and different interpretations, may become outdated or difficult to apply to a unique context for which there is no precedent. The result is often wasted time and resources, especially depending on the size and scope of the organization. It can be incredibly difficult to ensure all team members who are designing, implementing, and supporting clinical trials are sufficiently educated on the intersection of all the regulations involved.

What’s next? Solving the business burden

Sociocultural evolution continues to appropriately drive much-needed changes in the clinical trial space—from the experiments performed on the Tuskegee Airmen that were the genesis for informed consent to the latest European data privacy rules that are shaping who can collect and store personal data, and how. In the US, individual states are adopting data privacy regulations at an incredible rate.

When it comes to clinical trial regulations, who will sponsors and sites lean on to determine how data is handled? Are ethics committees and institutional review boards the ones to make decisions on the ethics of data handling? Over the next five to 10 years, these questions may be more complex than they have been in the past:

• How will the trial be run, and where?
• How will participants’ and caregivers’ data be handled?
• With differences at state levels in the US and country levels internationally, how will patient payments be handled? Are sponsors facilitating this themselves, or partnering with dedicated solution providers?

Sponsors and sites need to have reliable plans in place to mitigate the burden and resource drain that are inevitable parts of our changing industry. Technology plays a role in the solution, as does determination of where to turn for assurance of regulatory compliance.

The role of scalable patient convenience solutions

The path forward is patient convenience solutions driven by automation, compliance informed policies, and an appropriate level of transparency. In order to effectively and efficiently deliver convenience solutions anywhere in the world while adhering to banking, data privacy, and clinical trial regulations, technology that is both scalable and configurable by region and study requirements is necessary. Regional preference, patient choice in payment method, and global access have emerged as essential—and flexible technology solutions that eliminate much of the sponsor, CRO, site, and patient burden that exist.

Additionally, ideal technology solutions need to be able to streamline patient-site interactions, track study activities, and enforce policies compliant with jurisdictional regulations while maintaining the right to privacy for all people.

Data privacy issues still loom large as we examine our technological future as an industry, but the focal point must be on how we specifically eliminate this burden across stakeholders as technology advances. That’s where decision-makers need to weigh their options in terms of continued reliance on internal teams and processes versus establishing key vendor relationships that absorb these complexities.

Identifying trusted partners

Navigating global banking, data privacy, and clinical trial regulations is a notable investment, to be sure. A key part of the solution is identifying the right partner(s) to support operational efficiency while ensuring regional compliance.

For optimal international patient payment risk mitigation, a robust knowledge base in global banking regulations, data privacy, and clinical trial regulations is required. It is also important that all stakeholders are educated and able to effectively engage within the scope of compliance at the global level. And where there are gaps, outside counsel and specialized partners are essential in all relevant jurisdictions. What that means at the practical level is that you have to secure key team members and vendors in every single country and region where you conduct research. For example, if you’re working in an African country with multiple local dialects, you will need to employ enough team members to ensure blanket communication capabilities.

Without the right team at the ready to ensure every process is airtight, you introduce intolerable risk. No organization wants to make headlines that feed a lack of trust at the client, vendor, or patient level. After all, instilling trust across all stakeholders is critical to the success of a clinical trial. When determining whether to secure an external global partner, especially related to patient payments, it is critical to assess existing processes and identify the areas of vulnerability. Through recognition of organizational gaps, you gain a better understanding of the services and expertise required. This ultimately enables organizations to make the best decision on which partners to work with to eliminate risks, improve patient and site experiences, and drive operational efficiency.

In summary

Compliance in clinical research is paramount, especially since global regulations are constantly evolving. Remits such as patient convenience that span numerous regulated industries—clinical research, finance, and data privacy—require particular attention.

Understanding the challenges and regulatory hurdles is a key first step to identify the appropriate technology that is scalable, adaptable, and compliant. The more we can turn complexities into viable, accessible solutions, the greater the global impact we can make.

Craig Popovich, Associate Director, Implementation CIPP/E, Greenphire