Globally, more than 80 percent of clinical trial sites miss their enrollment target date, and as many as 55 percent of trials are terminated due to insufficient patient recruitment. Reasons often cited by potential patients for deciding not to enroll in trials — or dropping out prematurely once enrolled — include lack of patient support services, distance to study sites, travel costs, and the like.
One solution that many sponsors have turned to is the use of decentralized clinical trials (DCTs), which allow trials to take place at locations other than traditional, often hard-to-reach sites. Alternative locations can include local healthcare facilities, laboratories, or even patients’ homes, making clinical trials accessible to a broader patient population. Decentralized trials are a particularly attractive alternative in rare disease trials, which can include participants across a much broader geography, or immunocompromised individuals who are reluctant to go to hospitals due to the possibility of infection. Digital solutions, such as telehealth and smartphone applications, can help to facilitate such trials.
But what happens when a clinical trial requires something that patients can’t do or procure on their own? Direct-to-patient (DTP) services can include at-home care to administer treatment and collect biological samples required for the trial. This logistical value chain — which includes kitting, courier services, and global temperature controlled storage capabilities — plays a vital role in enabling at-home clinical trials with a number of considerations that can be leveraged to better reach and retain patients.
Kitting, Primary and Secondary Clinical Packaging
Clinical trial kitting brings together the materials needed for a given trial protocol — such as equipment, investigational products, and instructions — and provides them in a convenient package for use at trial sites. When those trial sites are the patients’ homes, kitting and clinical packaging are very important to ensure that patients or at-home care providers have everything necessary for the trial close at hand. This includes ancillary items that would be readily available in a hospital setting, but not in a home, such as a blood pressure cuff.
Determining how to assemble a DTP kit so that it can best reach and enable at-home trial participants depends on many factors. For example, some investigational products require more expensive temperature-controlled shipping to safeguard their viability, while most ancillary materials do not. Therefore, it is often most cost-effective to separate ancillary kits from investigational products, allowing clinical trial supplies with similar transport requirements to be shipped together. Another, separate consideration might be to group supplies that will be used at the same time, so that they are readily available and easy for patients or at-home care providers to utilize.
Additionally, it can be invaluable to listen to a variety of perspectives to learn what is needed for the kit. Clinical supply representatives at pharmaceutical and biotech companies are often most concerned with the investigational product. However, coordinating with clinical teams and home care providers is critical since they can offer useful insight into protocols and the design of a patient visit over the course of treatment. For instance, if a home care provider is retrieving a kit from a central site to bring to the patient, it may be beneficial to package materials in a way that makes it easy for that provider to transport just what is needed for one visit to the patient, rather than grouping the supplies for multiple visits together.
Delivery and pickup
In many cases, it is preferable to deliver trial supplies directly to, or pick up samples from, a patient’s home. In these situations, seamless delivery and pickup planning is important to minimize inconvenience to the patient and the at-home care professional, as well as to ensure the trial is conducted according to protocols. Timeliness of therapeutic use and any relevant tests can be critical to a clinical trial. So, there is little room for error in delivery timing. In addition, some protocols call for the disposal of any unused investigational product, which requires a courier to return it to a central site or depot for accountability and destruction.
Investigational products and samples also often require careful handling to ensure viability. Therefore, it is important to coordinate with at-home care providers, so that couriers can time arrivals to coincide with the provider’s visit for a smooth hand-off of sensitive materials in a way that safeguards them. Another way to streamline pickup of samples is for couriers to be prepared with boxes already labeled and ready for samples to be placed inside, so that they can be brought immediately to the relevant labs for analysis when the nurse completes the home visit.
One of the key advantages to utilizing decentralization rather than central trial sites is the ability to broaden the geographic range of clinical trials. However, when that includes expanding into additional countries, there are a number of unique challenges. Delivering investigational medical products to patients in dispersed locations often requires the navigation of international rules and regulations. It may take coordination with government agencies, and knowledge of local protocols, to successfully ensure timely delivery. For example, during COVID-19 lockdowns in India, Yourway obtained special permissions from local police and other government agencies, and followed local regulations for DTP delivery of an investigational product. This same level of complex coordination is required for delivery to patients located in areas of conflict.
Cultural considerations come into play for patient retention. This can be seen even in something as simple as a delivery vehicle. Patients in some cultures may feel more secure receiving a delivery at their home from a vehicle that is clearly marked, while patients in other cultures may prefer the privacy offered by an unmarked vehicle. These cultural complexities can vary from country to country, and the ability to understand and accommodate them accordingly can be important to a patient’s willingness to participate in the trial.
Making the most of DCTs
Studies have shown high recruitment and significantly better retention rates in DCTs, with some showing as much as 89 percent retention compared to 60 percent for traditional trial arms. The potential to use DCTs, including at-home trials, to help clinical studies succeed is clearly great. But to optimize the benefits of these at-home trials, and their ability to overcome barriers to reaching and retaining patients, takes more than just deploying at-home care providers or making use of digital tools — it takes logistical planning and expertise.