Top 5 Questions About The Decentralized Clinical Trial Solution “Home Trial Support”

Author: MRN

With the FDA’s patient-focused drug development (PFDD) four-part guidance series driving change in how the industry conduct clinical trials, more and more sponsors and trial sites are looking for ways to make their trials more accessible to more patients.

It is known that one of the most effective patient-centric solutions are those like MRN’s Home Trial Support (HTS). The HTS service has played a critical role in enabling higher patient enrollment, engagement, and retention across clinical trials in a variety of indications.

Today, MRN has conducted over 112,000 in-home visits across the globe. The service has had a positive impact on patients, sponsors, and sites alike – creating more accessible trials sites that can enroll more patients without over-extending their resources, accelerating trial timelines which helps sponsors bring critical therapies to market, faster.

But how do we do this while ensuring that patient safety, and guaranteeing data integrity? MRN’s expert team answer this by addressing the top FAQs that sponsors, sites, Clinical Research Organizations (CROs) and even patients have about HTS.

Question One

Q:          What type of clinical research and study-specific training do the home healthcare professionals (HCPs) have?

A:          Before a patient visit takes place, any person conducting a trial in the home should  receive comprehensive training and testing, passing with 100% competency. This includes full GCP training, with data privacy and confidentiality modules, renewed every two years. In addition,  training on conducting in-home clinical trials as well as  key deliverables and protocol-specific training is given. Additional training is also provided depending on the study,  for example, when it comes to trials for infectious diseases, vendors should provide additional instructions, training, and precautions needed etc. related to the virus.

All study-related training MRN provides is unique to each trial. Our Clinical Services team collaborates with the Sponsor to carefully ensure our HCPs receive the correct training and documents.

Why is this important?
By starting with high-quality, intensive training, our HCPs can deliver high-quality, accelerated results.

Question Two

Q:          Are the home HCPs available to answer patient questions when they’re not at the patient’s home?

A:          Usually the responsibility for answering medical/study-specific questions lies with the Principal Investigator (PI) and study team. We encourage patients reaching out to their PI and study staff, as it helps to maintain that relationship.

However, patients should have HCP contact information so they can contact the HCPs regarding the logistics of their appointments etc. as needed.

Why is this important?
Patients should still feel connected to the study overall, as they’ll still need to engage with the study site team at various times during the trial. Patients also remain the PI’s responsibility and need to feel comfortable providing any additional information or details to the PI and the study team if needed.

Question Three

Q:          What type of equipment is brought into a patient’s home for a visit vs. left at a patient’s home?

A:          The equipment will be study-specific and dependent on the procedures that need to be administered. They can include things as large as a centrifuge or as simple as a blood pressure monitor. Any equipment required for the HCP to complete their visit is brought with them and, usually, taken away afterwards. MRN’s procedures ensure that any Investigative Medicinal Products (IMPs) are transported via a premium courier at a specified time for the visit.

There should be very little, if nothing, left in the patient’s home. Occasionally there may be a requirement for small items to be available to the patient after the visit. If anything needs to be left behind, it’ll be agreed upon by the sponsor, site and patient at the start.

Why is this important?
The fact that HCPs can bring equipment usually kept at a study site to the patient, or administer IMPs that would usually require a pharmacy, plays a key part in alleviating patient burden – patients don’t need to visit the study site for these procedures. By leaving nothing or very little behind, patients can continue with their day-to-day without cumbersome additional responsibilities. While very occasionally small items  do need to remain, we ensure the patient is completely capable and comfortable with it – again putting them first and foremost. This all plays a critical role in keeping patients fully engaged in the trial to the end.

Question Four

Q:          Who addresses queries that might result from data gathered by an in-home HCP?

A:          The most efficient way to address queries when data is entered from an in-home visit is by entering data into an eSource platform.  MRN’s HTS service includes our integrated, regulatory approved and validated eSource system. This allows our HCPs to digitally submit their visit reports via e-visit report forms (eVRFs).

Every time data is entered into the eVRF, the system will automatically pick-up if there is incorrect and/or missing data and highlight it – prompting the HCP to review their intended submission.

An additional manual check is also recommended.  MRN have manual checks in place, with a Clinical team as well as the visit delivery team performing different types of reviews and gap-checks throughout the length of the study.

Why is this important?
Accurate, quality data is critical for the success of any study. Without it, the study is unlikely to be approved by the relevant health authority. It’s also a tripping point for many clinical trials – often due to inefficient/outdated digital systems and overwhelmed sites. The combination of MRN’s eSource system and dedicated review teams helps guarantee that all data collected by our HCPs is of the highest quality, with any variables explained and accounted for.

Question Five

Q:          Is it important to include home healthcare components in the study protocol from the beginning?

A:          It’s important to us that Sponsors see a maximum return on investment. This is why we strongly recommend we conduct a feasibility assessment at the very beginning. By granting access to the protocol in the draft stage allows us to make the recommendations and provide input that’ll ensure home visits are strategically and effectively implemented from an operational perspective, and minimize costly delays along the way.

However, this does not mean that DCT solutions won’t be successful or cannot be worked into an existing protocol. Our team will work with and gather input from all involved in the trial to advise on the necessary study and protocol amendments required. Simultaneously, MRN will prepare to deploy the necessary HTS services to help drive patient recruitment and retention success as soon as the protocol amendments have been approved.

Why is this important?
MRN’s project management and clinical services teams are experts in both collaborating with Sponsors to design their trial to incorporate DCT aspects, such as the HTS service, as well as reviewing and revising protocols to include them after the study has started. Their keen understanding of local review boards and regulators ensures their ability to incorporate DCT solutions into feasible protocols, rapidly and effectively.

Back to the newsroom