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Inclusivity

How do you incorporate the caregiver in your clinical trial?

Cassidi Williams

We could not do it without them! Caregivers are the biggest support system for many patients and are often working adults who provide care in their off-work hours to family members, spouses or children. Caregivers also look like the elderly providing care for a spouse, parents of children with disabilities and home health aides. It’s these responsibilities that they already face in their daily routines that are making it difficult get participants enrolled to in-clinic site visits and typically, traditional trial designs create competing priorities for caregivers and their patients.

So, how can you remove the caregiver burden of participating in clinical trials to increase participation?

  1. Through Recruitment -Typically, research recruitment is targeted at patients and not the caregivers, even though some participants are unable to search the internet for appropriate trials. That means the caregiver is the person who will reach out to the study team, making it important to keep the caregivers in mind when setting up recruitment strategies. You should create study-based recruitment websites that can be found easily online and are targeted to both the patient and caregiver.
  2. Through Data Collection - The role of the caregiver may be the critical factor in quality data collection and adherence to protocol. They are often responsible for providing data for multiple participants, which must be supported by the technologies being utilized in the study. Caregivers are required to report details on adverse events, provide support for the patient and be a patient advocate so the implementation of decentralized clinical trial (DCT) technologies can collect data from multiple caregivers on their own device, increasing compliance within the trial.
  3. Through Virtual Visits - COVID-19 has made it extremely risky for patients to travel to a clinical site for study visits. Travelling to the site alone can be daunting for the caregiver and virtual visits allow the required visits to occur remotely using telehealth capabilities. The use of telehealth is ideal for studies with a caregiver because of the ability for caregivers to interact directly with the staff who are knowledgeable about the clinical trial. This does not eliminate the need for in-clinic visits, it just creates a flexible option, increasing the likelihood of the patient’s retention throughout the study.

Overall, the caregiver provides a significant role in determining the success of the patient within a trial targeting their subjects. They often go above and beyond their caregiver role and should be factored into every step of your clinical trial, from the protocol design phase all the way through to the results phase. Caregivers are the biggest support system for many patients and the industry needs to create a methodical process that generates quality data and gives caregivers the necessary support. We expect so much from them that we need to provide them with the technology, training, and support to ease their burdens. Read the THREAD report on ‘The Crucial Role of the Caregiver’.