How MRN Delivers Home Trial Support Solutions On A Global Scale

Author: MRN

Patient recruitment and retention is not just a problem faced by one country, or even one continent – it is a continued challenge on a global scale, with dropout rates averaging 30% across all clinical trials and recruitment costs averaging $6,533 per patient.1 Furthermore, studies continue to show that there is continued underrepresentation of different demographics, including pediatric, elderly and minority groups which affect the real-world data and generalizability of clinical trials and their findings.2

One of the more the successful2,3 ways to overcome these challenges is through the implementation of Home Healthcare solutions. These solutions see a Healthcare Professional (HCP) visit the patient in their home or other appropriate place to conduct a number of the clinical trial visits, as agreed with by the Sponsor and study Principal Investigator (PI). This means the patient does not need to travel to and from the clinical trial site for all of their visits, rather having them at a convenient time in their chosen location, which is usually the home, with an HCP that is fully focused on them during those visits.

In order to offer in-home healthcare on a global scale, service providers should know and understand that their model cannot be a one-size fits all. Just as different patients have different needs and requirements, so do different countries, and providers should be able to tailor their services to those needs. This blog will explore some of the key areas which require country-specific tailoring.

Regulatory Requirements & Compliance

When we start discussing regulatory requirements and compliance there is often an assumption that this means GCP and regional/country/continent-specific medical health authorities (such as the FDA, EMA etc.). While all of these are important and absolutely must be met in order run in-home health services, there are other requirements that are not so straightforward.

The Global Data Protection Regulation (GDPR)

GDPR first came into effect in the European Union, with all member countries adopting this as law. However, similar laws that include some, if not all the GDPR principles, have since been passed – from the United Kingdom’s UK GDPR to California’s Consumer Privacy Act to Japan’s Act on the Protection of Personal Data.

These laws all impact how personal health information and personal identifiable information is handled, processed and stored. It requires a team that has a deep understanding of these laws and what actions are required to ensure that they are followed.

Healthcare Professional Education & Experience

The requirements in experience and medical training can vary vastly from country to country, with HCPs requiring different levels of training and experience in their field in order to conduct in-home trial visits.

Some countries, such as Japan, require a physician to monitor the administration of the Investigational Medicinal Product (IMP) and other procedures, while in many others a nurse or physician assistant, who has a number of years’ experience in their field, is considered qualified to do so without physician oversight. For some countries it may be that the HCP needs to be a specialist in their field, with additional qualifications.

These requirements are not always clear cut either and can vary from study to study – dependent on the type of IMP, procedures to be carried out, and therapeutic indication.

Patient Protocol Adherence & Cultural Understanding

The number of site visits vs. HTS visits will vary from trial to trial, but when it comes to ensuring protocol adherence there is often concern that in-home visit protocol adherence may not be as stringent as it should.

However, studies4,5 have found that in fact the opposite is true. They have found that not only is adherence maintained, but it is also often improved. This is due to in-home HCPs having the time to observe patients in their home environment and recommend interventions as required, further they also have the dedicated 1:1 time to spend with the patient and their family/carer to educate them and ensure a good level of understanding.

Yet delivering quality in-home visits is not just about the HCPs ability to ensure adherence – it is also about their skills to build a relationship with the patient. To accomplish this on both a global & regional level in-home HCPs need to have both local knowledge and training. Ideally, they will be local to the area (or similar), speak the same dialect as their patient and their family/caregiver, and have an understanding of any religious or cultural requirements that accompany the process of visiting someone’s home.

This ensures that the HCP is able to connect with the patient and their family-caregiver on a much deeper level – helping not only ensure protocol adherence but continued patient engagement.

Delivering Home Trial Solutions, Globally

It takes a team with not only experience, but a deep understanding of the nuances behind delivering clinical trails in-home and in different communities, around the world. MRN has nearly 20-years’ experience in providing these services, and operates in 99 countries. The HTS teams work together in unison, with a central team working with their local counterparts to ensure clinical trial delivery success – for patients, sites and sponsors.

Find out how MRN can support your trial with HTS, wherever you and your patients are.

References:

  1. Oakley-Girvan I. Unique Considerations for Patient Retention in Decentralized Clinical Trials. Clinical Researcher, Vol37,1. Feb 2023. https://acrpnet.org/2023/02/22/unique-considerations-for-patient-retention-in-decentralized-clinical-trials. Last accessed July 2025.
  2. Medical Research Network. Recruiting & Retaining More Patients Per Site – A Global ALS Case Study. https://themrn.io/newsroom/resources_posts/amyotrophic-lateral-sclerosis-als-case-study/. Last accessed July 2025.
  3. Medical Research Network. Improved Recruitment Through Home Trial Support. https://themrn.io/newsroom/resources_posts/improved-recruitment-through-home-trial-support/. Last accessed July 2025.
  4. Lizano-Díez I, et al. Impact of Home Care Services on Patient and Economic Outcomes: A Targeted Review. Home Health Care Management & Practice. 2021;34(2):148-162. doi:10.1177/10848223211038305
  5. Ghimire A, et al. A single home visit improves adherence and reduces healthcare utilization in patients with frequent exacerbations of Severe Asthma and COPD. Respiratory Medicine: X, Vol3, 2021. https://www.sciencedirect.com/science/article/pii/S2590143521000014. Last accessed July 2025.
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