Bringing Clinical Trials Home: An mdgroup White Paper

Patient-perceived travel barriers were the second-most-cited reason for non-participation in clinical trials, according to a 2013 study.

As biopharmaceutical companies compete to bring effective drugs to the market, attracting a sizeable sample of clinical trial patients is increasingly important. With a global focus on patient centricity as a way to boost enrolment and decrease drop-outs, CROs are considering the logistics of providing treatment in patients’ own homes.

This measure would require significant logistical planning, with trial supplies needing to be packaged and safely transported across the world. Furthermore, accurate and regular measurements of each patient’s condition will need to be taken despite the distance.

Nonetheless, the hard work should pay off, removing the perceived barriers of travel time and cost, and encouraging a greater number of patients to enrol for potentially life-saving clinical trials.

We explore the patient-centric drivers and potential challenges of providing home care to a greater number of clinical trial patients, including tips on using technology to streamline the process for the benefit of patients and researchers alike.

Problem

Thanks to technological advances such as trial matching apps and AI algorithms, patients have better access to clinical trials, specialist centres and physicians than ever before, with geographical location becoming less and less of an issue.

Particularly in the case of orphan diseases, defined as affecting fewer than 200,000 people nationwide, online services have drastically improved CROs’ chances of finding the right trial participants and bringing them together from across the globe.

In such cases, it’s crucial to enrol as many patients as possible and avoid dropouts, ensuring the already-small study sample size isn’t further compromised.

However, many patients are reluctant to travel long distances, or to be away from home for long periods of time. Furthermore, certain illnesses are comorbid with mobility restrictions, making it even less likely that patients will be able to commit to a trial that involves regular travel.

Travel remains a significant barrier to patients even in highly competitive and more localised trials. Less than 3% of cancer patients in the USA participate in available trials, despite a large proportion of government-sponsored trials being conducted at National Cancer Institute centres, which are located so that 45% of Americans live within a reasonable travel time of one.

In order to provide truly patient-centric services through trials of all sizes, we need to consider patients’ needs more closely. Already inconvenienced by the rigours of their illnesses, patients are unlikely to choose to commit to anything that further compromises their work, family, or social lives. Rather than expecting patients to make sacrifices for the sake of trial participation, we need to rethink how we can bring trials to them.

Solution

The Direct to Patient (DTP) model has already seen success in delivering drugs to patients’ homes and collecting samples throughout clinical trials.

This process allows patients to either administer their own medicines or receive regular visits from caregivers for clinical support. This reduces the need for travel to and from investigator sites, and gives patients a greater sense of control over their own trial experiences.

Services such as patientprimary allow patients to take the reins when it comes to home visits, offering a streamlined and easy-to-use app through which patients can make appointments for home care visits, book chauffeured accommodation for any necessary site visits, and offer their feedback.

Employing a DTP model during a trial, with sufficient support from technology, has been proven to reduce out-of-home trial visits by more than half, proving far less disruptive to patients’ day-to-day lives.

Taking clinical trial technology one step further, e-clinical or virtual trials collect data efficiently and actively via wearable devices and IoT-connected sensors, minimising intrusion from clinical visitors. This has the additional benefit of expanding the reach of trial sites, allowing patients around the world to participate in one central trial.

Benefits

  • Patients will feel like they have more control over their trial participation, and over their day-to-day lives during the trial. This will lead to increased enrolment and decreased dropout rates, with the patient-perceived travel barrier removed from consideration.
  • In collaboration with apps, smart sensors and other mobile technologies, home care can significantly reduce site burden, freeing hospital beds, site resources and practitioner time. This will in turn cut trial costs, bringing drugs to the market more efficiently.
  • A well-organised DTP service can improve visibility of drug shipments, cutting down on wasted medicines and simplifying the returns and accountability processes for the patient.
  • Data collection via apps and connected devices will allow trials to operate over wider areas, particularly benefiting orphan drug trials, in which patients would usually have to travel internationally to be involved.
  • Patient support apps will also give patients direct access to their own trial information, allowing them to feel more involved with the process and encouraging them to ask questions and offer feedback.

Challenges

Many aspects of home-based clinical trials are still in their infancy, and bringing them together into a successful trial that benefits both patients and researches requires a lot of consideration.

Firstly, international guidelines and regulations should be taken into account, particularly with regards to large-scale multi-national trials. Many countries don’t yet have rules and regulations for DTP and telehealth models, meaning that protocols need to be approved on a case-by-case basis. This can lead to significant delays in getting drugs onto the market.

This will be remedied in time, as home care services and supporting technologies become more widespread. Nonetheless, in the meantime it’s important to spread awareness about these advances and their benefits, promoting conversation at all levels, from local practitioners to regulatory bodies.

It would also benefit CROs considering home-based clinical trials to include a specific section in CPTs explaining how home care, DPT services and associated apps and monitors can support patient treatment in a safe, confidential fashion.

The same approach will need to be given to informed consent forms, which should outline home care protocols and data collection methods in a way that’s easy for patients to understand, allowing them to make an educated and personal decision about whether the benefits of a home-based trial outweigh any risks.

In cases where medication is delivered directly to patients, a protocol needs to be developed in line with ICH Good Clinical Practice guidelines, requiring the trial site pharmacy to store study drugs and distribute appropriate doses to approved and specialised couriers.

As expected, secure transfer of both the medicines and data are a top concern for both patients and researchers. Personal and medical data will be processed at every part of the delivery process, from shipment data and proof of delivery to clinical information gained from apps and devices. CROs will need to develop their double-blind protocols to ensure that couriers and sponsors don’t gain access to sensitive data at any point in the process.

It’s therefore important for CROs to work with a trusted home care organisation of patient service provider, who are aware of safety and security guidelines, and will strive to ensure that patients and their information remain compromised.

Summary

While much research and regulation still needs to go into home care protocols and procedures in clinical trials, the concept is doubtlessly one that will benefit both the trials themselves and the patients participating in them.

With patient centricity taking a more and more fundamental role in the way we plan and conceptualise clinical trials, we can anticipate a future in which patients are able to confidently sign up for a trial, knowing that they can contribute to the future of life-saving medicine without facing the burden of unnecessary travel and trial appointments.

If you’re looking for a more patient-centric direction for your next clinical trial, check out our patientprimary services and expensefirst app, streamlining the trial process for patients and practitioners alike.