Glenda Womack

	Historically, some clinical trial models have had difficulty in the past with low recruitment, high withdrawal rates, and low results on company perception surveys due to participation burdens. When trials are designed with the patient in mind, the participation barriers can be minimized, ultimately supporting recruitment and retention efforts. One of the biggest hurdles that clinical teams can look to overcome is the requirement for a patient to travel to a hospital or clinic for treatment. While centralizing a trial at a hospital or clinic may allow for easier medication transport, data collection and travel can be taxing for patients, both financially and physically.

	As a patient-centric solution, CROs and sponsors are taking the clinical trial to the patient, conducting assessments, and administering medications in patient homes instead of in a hospital or clinic. This can be successfully executed with the use of and collaboration with ambulant care service providers that offer skilled clinicians who are qualified to administer intravenous injections and infusions or subcutaneous injections. With this approach, clinic visits are often reduced and patient participation is simplified.

	While in-home trials can address participation issues and provide added convenience and support for patients, they come with their own set of risks. Several challenges include:

	·       Improper medication storage, particularly when temperature monitoring and control is paramount

	·       Managing access to caregivers and patients only, and ensuring that medications are secure from unauthorized persons, including children and visitors

	·       High shipping and storage costs for sensitive medications

	·       Ensuring adherence, especially when it is the patient’s responsibility to know when and how to take the medication

	·       Collecting and integrating data when the information is decentralized

	To mitigate the risks of in-home trials, CROs and sponsors have implemented several strategies, including using shippers with extended stability for storage in patients’ homes, tamper-evident tape to indicate unauthorized access, temperature data loggers to track and report product storage, and dosing diaries to identify when the study drug was administered. Even with these strategies in place, CROs and sponsors should be mindful that they are not a silver bullet and they do not fully address all of the potential risks. For example, unreliable temperature monitoring can lead to costly false alarms, which may disrupt patient care, waste drugs, and increase costs. Patient utilization data tracking and collection continues to be an issue as well.

	CROs and sponsors need to evaluate solutions that address these clinical supply chain issues without creating additional obstacles. A checklist might include evaluating solutions that create a stable, long-term environment for medications; accurately monitor and control temperature; integrate and track utilization data; promote patient participation and compliance; support safety measures by limiting access to authorized individuals, and help manage the cost of shipping and strong storage of medications. 

At AmerisourceBergen, we decided to leverage our Cubixx technology and experience supporting patients in their home to develop a solution that could help CROs and sponsors navigate the challenges and capitalize on the potential of patient-centric clinical trials. That solution is CubixxCT, a refrigeration system that leverages technology, is used by a number of provider institutions to conveniently deliver investigational drugs to a patient’s front door. The system maintains temperature control within a single degree, provides inventory visibility and transparency, alerts the research team when it is time to replenish the medication, and can be customized to deliver a wide range of data depending on sponsor needs. It can also be password-protected, to make sure that only the patient, his or her caregiver, or other authorized personnel can access the medication. CubixxCT is just one solution solving pain points that have traditionally kept patients from participating in clinical trials and study teams from efficiently and cost-effectively managing trials in homes.

	As sponsors continue to evaluate the shift to patient-centric clinical trials, they must keep the opportunities and challenges that exist in mind. Being mindful of the barriers that exist in in-home trials, building a checklist, and finding solutions and partners to help address those challenges from the beginning is critical. If set-up properly, CROs and sponsors can reap the benefits of higher participation, adherence, and data in their research, all while providing better care for patients. By prioritizing the patient’s needs and lowering or removing barriers he or she might face, sponsors set themselves up for a successful first interaction, and ultimately, a stronger relationship throughout that patient’s treatment.

Director of Client Operations & Business Innovation at Cubixx® Solutions, a part of AmerisourceBergen.

Articles

CRO's and sponsors are taking clinical trials to homes. These in-home trials can address participation issues and provide added convenience plus support for patients, but they also come with their own set of risks.

Glenda Womack

Articles

In-Home Trial Supply Challenges