Multi-national studies call for informed approach: Firma Clinical Research

Any clinical trial is a complex operation; when that study is run across multiple sites in several countries, the complexity grows significantly. Nikki Skirvin, director of clinical operations for Firma Clinical Research, explains some of the unique challenges of running a multi-national study, key considerations, and solutions that can streamline the process.

OSP: How did the arrival of the pandemic impact the home trial business?​

NS: The arrival of the pandemic heightened the need for patient-centric solutions such as home trial visits. Our early conversations were focused on how we could provide continuity to patients in ongoing studies when they did not feel comfortable going to the study sites. In some regions, travel to study sites was not permitted, therefore, home trial visits became the only way those studies could continue. 

More recently, the conversation has shifted to how can we incorporate home trial visits into the protocol from the beginning of the study. The pandemic has made home trial visits less of a rarity and enabled teams to realize the ongoing benefit they could gain from including the services from the start. Offering home trial services as an option to patients in the original protocol has truly made studies much more patient-centric.

OSP: You’re currently offering your home health services in more than 45 countries—could you please talk about some of the general challenges in running a multinational study, and more specifically what you need to consider when going into people’s houses in multiple countries?​

NS: Conducting home trial visits globally can certainly present challenges. Some of the most common challenges are as follows:

• European Union (EU) General Data Protection Regulation (GDPR) can require trial data to remain in the country of origin, which means that the global partner must have a physical office in that country
• EU GDPR can also place more stringent guidelines on how personal health information (PHI) and personal identifiable information (PII) are handled
• cultural restrictions can limit or prevent the use of home trial visits
• specific expertise (e.g., MD) can be required to complete certain visits in certain regions
• administration of investigational product (IP) outside of a medical facility is not allowed in some countries, especially in the case of IP IV infusion administration as they view that activity as too complex to be completed in the home

Firma is able to tackle these challenges by having a sound infrastructure and years of experience in this arena. We have a data protection officer who is actively involved in navigating the GPDR intricacies, local to the participant nurses that understand the cultural nuances, and our years of experience allow us to have a database with the current regulatory and cultural climate. This, coupled with project managers experienced in-home health, helps us excel at conducting multi-national home health studies.

OSP: Specifically, how do you stay on top of regulatory requirements, and ensure in-home components are in line in all these countries?​

NS: Our data privacy officer, who is based in France, ensures the global home trial services are conducted in accordance with current privacy regulations. Additionally, Firma works with several global partners that provide frequent regulatory updates in each of the countries, so we stay up to date at all times.

OSP: What about protocol compliance—what challenges does introducing an at-home component maybe lead to?​

NS: Protocol compliance is often significantly enhanced with the addition of home trial visits. Patients are more compliant with their visits and will remain in the trial longer if they have the option of home trial visits throughout the duration of the trial. And Firma excels at training our providers to the protocol in a complete and consistent manner so there is no risk of disparity.

Some challenges can still present themselves. Specialized equipment that is needed for certain activities/procedures may not be portable, either due to the weight of the equipment or the expense. Or country-level guidelines may restrict the type of visit activities/procedures that a provider can perform. Nurses in North America, for example, can conduct assessments that involve palpation and a review of body systems, but globally nurses cannot palpate as it is outside their scope of practice.

That’s why early engagement is key to understanding the protocol requirements/visit schedule to determine which can be completed as home trial visits.

OSP: How do you find and recruit professionals who are able to go into a patient’s home and provide service that meets your client’s (and Firma’s) standards?​

NS: Selection of appropriate home healthcare providers is an important factor when working within the clinical trial setting. During trial set-up, Firma and the client we’re working with will agree to the qualifications required based on our experience with home healthcare as well as protocol required procedures.

A comprehensive trial-specific and customized training will be created by Firma based on the trial protocol, central laboratory manual (as applicable), and CRF, and the study team will provide their review, feedback, and approval of the study-specific documents prior to the initiation of services. Firma partners with several national and global agencies, and every individual provider is required to pass a protocol comprehension exam at the end of the training.

Firma team members lead the training directly to ensure each provider understands protocol and visit expectations, and those Firma trainers are available to the providers during visit execution.

Our home health providers are really an extension of the site staff, so the PI will receive their CV, license(s), certification(s), and training records for review and approval of the assignment prior to any visits being undertaken. Firma also encourages pre-visit calls/meetings between the PI and proposed provider should the PI/site wish for this level of engagement. Finally, the provider along with the PI may sign the site’s Delegation of Authority (DoA) Log.

OSP: Do you have any advice for a study team looking to add in-home services to a trial (particularly a multi-national study)?​

NS: Ensure that the study team engages with their home trial services’ (HTS) partner very early in the protocol development process. They will serve as a subject matter expert on the visit activities/procedures that can be performed in the home as well as being the resource for the most current global regulations surrounding HTS.

Have the HTS partner train the trial CRAs on their services and invite the partner to IMs and SIVs. This really early engagement allows the site teams to be introduced to HTS when they are introduced to the trial itself. This ensures that HTS is part of the trial and not simply an add-on for the site to use only in dire circumstances.

Accommodating the needs of patients in a clinical trial is key to enhancing patient recruitment and retention. Whether initiating at the start of a trial or even within an ongoing trial to ensure reaching enrollment timelines, HTS helps bring the trial to the patient and significantly lowers the barriers that potential research participants may face when deciding to participate in a clinical trial.

Home-based services for clinical trials are being used globally to enhance participant enrollment and retention in a broad range of therapeutic areas and indications. Obviously, enhancing enrollment and ongoing participant compliance will positively impact overall trial costs, results, and timelines. Specifically, implementation of HTS enables the client to:

• Lower the patient/family burden for participation, increasing the favorability of their enrollment
• Expansion of the potential enrollment patient pool by engaging those who may have mobility issues or are part of a more vulnerable population with weakened health status which may have been previously dissuaded from participating
• Enable sites to increase focus on seeking additional patients in the trial by reducing administrative burdens
• Differentiate the client’s trial as preferential to competitors’ currently undergoing trials
• Enhance patient retention by providing greater support and convenience, while also increasing the patient’s sense of accountability as a research participant

OSP: Anything to add?​

NS: Firma) is a niche service provider who believes a patient-centric approach is key to unlocking positive outcomes in the drug and medical device development process.

Firma offers its clients a strong partner for patient support on every trial given:

• Nearly 83% of Firma’s supported trials include biological specimen collection and processing (e.g., blood, urine, stool, etc.) for either central, specialty, local site laboratories, or all the above totaling over 40,000 samples collected/processed.
• Our robust training and support for our Home Trial Providers (HTPs) ensures samples are collected, processed, packaged, and shipped according to laboratory requirements in order to arrive at their destination in stable condition for further laboratory analysis.
• 40% of Firma’s supported trials include IP administration for multiple administration routes, including IV infusion.
• 98% of the over 133,000 completed home trial visits by Firma HTPs have been conducted within the protocol visit windows.
• Firma has supported approximately 15 studies in the oncology therapeutic area in the last 5 years with most of them including blood sample collection.
• Firma’s client satisfaction level is unparalleled as demonstrated by our level of repeat business (more than 80% of our clients have placed at least 2 trials with us for patient support - many before the first formally completed) and our strong references. We welcome the opportunity to provide Sponsor references for further contact related to our services and patient support efforts.
• Our team members continually examine creative and alternative solutions to ensure alignment with the financial and operational needs of the trial.