As the pace of life increases, so does the need for convenience. Changes in consumer products over the past decade highlight this trend, and more recently so do changes in healthcare and medicine. But changes in healthcare and medicine are slower to adapt. Innovation to overcome complex processes, as well as procedures that require an in-person visit with a healthcare professional, are necessary to meet the need for convenience.

Not offering convenience in clinical trials comes with consequences. Approximately 30 percent of patients drop out of studies before completion, leading to data loss and potential approval delays. However, more participants enroll and stay enrolled in studies when they can participate from a location convenient to them.

While home healthcare is not new, home healthcare for clinical trials poses challenges. Often, biological samples collected from patients or drugs administered to patients require strict temperature control—generally controlled room temperature or between 2 to 8°C. Innovative temperature-controlled packaging can help resolve these challenges and address the growing need for convenience in clinical trials.

Drive for convenience
Convenience in clinical trials is driven by both want and necessity. Study protocols are increasingly complex. They require extensive data collection and utilize complicated drug regimens. This can deter patients from participating in a trial because it leads to frequent travel to a clinical site for routine drug administration, sample collection and simple tests.

It is true that some study participants prefer not to travel to a clinic or physician’s office for care. They enjoy the convenience of receiving healthcare from home. For many study participants, home healthcare is a necessity.

Increasingly, investigators conduct clinical trials on a global scale, which expands the populations that can enroll in a trial. Collection centers where samples are managed are likely not close to participants’ homes. Some participants may live in rural areas not close to the investigator site, a clinic or a physician’s office. Other participants may be located in a different country than the investigator site.

Additionally, some participants are unable to travel due to health or age-related issues. Others may find themselves unable to leave their place of employment for clinic visits. And some desire a vacation that might interrupt regular sample collection or drug administration. Home healthcare services increase clinical trial protocol compliance, lead to higher retention rates and improve patient willingness to participate.

Direct-to-patient and direct-from-patient solutions
Making clinical trials more patient-centric is among one of the many challenges facing the pharmaceutical industry. One method to improve the patient experience involves delivering study medications directly to patient homes or a nearby medical facility. This is known as direct-to-patient (DtP) care. Because this model is complex, it requires investigators to establish procedures and agreements with all parties to ensure medication distribution is handled properly and that medication is delivered in temperature range and good quality condition.

By contrast, direct-from-patient (DfP) involves materials that originate from patient homes. Most often these are samples, like blood, collected by a healthcare professional and sent to a laboratory for testing. It is worth noting, however, that this is also an option for some diagnostic testing that does not involve a healthcare professional. This may include things like a stool sample to test for colon cancer. Many of these samples require strict temperature control. Specialty couriers help supply packaging, refrigerants and temperature monitors, as needed, and pick up laboratory samples to ship for testing.

In both DtP and DfP activities, coordination and timing is important. One late delivery or temperature fluctuation can compromise a study or endanger a patient. The right training, procedures and temperature-controlled packaging are critical.

Logistical challenges
Delivering and administering drugs DtP or collecting samples DfP in a home healthcare setting poses challenges. This is especially true for temperature-sensitive samples and drugs. Home healthcare teams, including nurses and phlebotomists, must understand temperature requirements for collected samples and drugs they administer. While samples, in particular, don’t have monetary value, they are irreplaceable.

The use of temperature-sensitive samples and drugs in clinical trials continues to rise. Currently, 50 percent of collected samples require a controlled temperature range. Samples provide important clinical trial study data that helps investigators understand how participants react to drugs throughout a study.

Failure to maintain the appropriate temperatures for samples can render them useless. This can cause delays if home healthcare workers need to recollect samples, or it can mean one less data point that prevents investigators from proving or disproving the effectiveness and safety of a drug. It is important that home healthcare workers understand how to maintain appropriate temperature control of samples throughout the clinical trial process, including how to use temperature-controlled packaging.

Temperature-controlled packaging
There are a number of temperature-controlled packaging options on the market. Dry ice and refrigerated shippers for frozen and chilled samples historically require accommodations to source and supply dry ice and gel coolants respectively. This means pharmaceutical logistics personnel must coordinate these specialized needs for DtP and DfP shipping activities.

Companies specializing in temperature-controlled packaging now make single-use and reusable refrigerated shippers that are easier to use at remote sites. These new refrigerated shipping systems require no sourcing of gel coolants or conditioning, and they weigh significantly less than shippers that use phase change material. These systems use evaporative, reactive cooling technology that responds and adjusts to varying ambient temperatures. This ensures the payload is protected from external temperature fluctuations throughout the duration of the shipping process. Just one touch of a button activates the cooling process for refrigerated samples. These options require little training for home healthcare workers and are easy enough for patients to use themselves.

With an increase in collection of tissue samples from tumors and other diseased tissue being treated by different cancer drugs, which require controlled or refrigerated temperatures, companies are investing time in temperature-controlled packaging to keep these tissues cold and protected during shipment. Additionally, smaller and lighter sample transport packaging is gaining momentum. Simple innovations like handles and straps that make it easier for healthcare professionals to carry shippers between home, clinic and post office are also becoming more common.

The future
DtP and DfP activities are fairly new, only taking off over the past few years. While not all clinical trials can offer home-based solutions, currently only 24 percent offer this option. There’s room for growth, and it is further warranted by the challenges related to a global pandemic.

Studies show that 50 percent of patients are more likely to participate in a clinical trial if home care is offered. Additionally, DtP service helps maintain patient retention rates at more than 95 percent, allowing investigators to expedite trial timelines and bring products to market more quickly.

During the course of COVID-19, the majority of clinical trials were either suspended or adjusted to delay milestones. While some delays were out of concern for how COVID-19 may affect patient health and clinical trial study results, many delays were related to logistical challenges to prevent the spread of COVID-19. Even as studies resume, participants may be hesitant to spend time in a medical facility to participate in a clinical trial. Participants may find themselves more comfortable with one-to-one care from a home healthcare worker, driving up the demand for these services.

If investigators have not considered or explored the idea of DtP and DfP activities from clinical trials, it may be helpful to partner with a specialty logistics company. Many of these companies work in and understand unique requirements of markets across the globe. They also have knowledge of temperature-controlled packaging and the companies that provide these products, as well as a network of locations for pick up, delivery and return management.

Each year, investigators spend approximately $2.28 billion recruiting participants for clinical trials. These studies are important. They help improve quality of life, save lives and ensure safety of preventive and supportive drugs.

Yet two thirds of investigator sites fail to meet enrollment requirements. When possible, offering DtP and DfP services for clinical trials can improve enrollment, retention and compliance. Though it is complex, especially working globally, things like sophisticated logistics organizations working in this space and newer, easier temperature-controlled packaging options make the process less daunting than it was a few years ago.

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Vince Paolizzi has over 15 years of experience in various sales leadership roles within the pharmaceutical packaging industry. He is responsible for the global sales growth of Pelican BioThermal’s NanoCool line of products. Paolizzi’s experience includes key account management to maintain strong relationships with customers as well as managing multi-disciplined project teams to secure new accounts. Prior to joining Pelican BioThermal, Paolizzi held various sales positions within the packaging, tooling and food industries.