Clinical Trials Have Put Patients at the Center—But What About Caregivers?

Clinical Researcher—January 2021 (Volume 35, Issue 1)


Jennifer Price


Patient centricity is now a key focus area for clinical trial sponsors and clinical research organizations (CROs) eager to develop better protocols, support more inclusive study designs, and increase participant engagement from recruitment to study close-out.

Whether it’s patient-centered study design, focus groups, satisfaction surveys, rapid reimbursement, or remote reporting, sponsors are devoting a tremendous amount of effort to attracting and retaining study participants. This is to be expected, as clinical trials comprise nearly 40% of the research budget for U.S. pharmaceutical companies, but come with an average study dropout rate of 30%.

Still, a crucial factor in the success of patient-centric activities seems to have avoided gaining notice to any significant degree in many trials, and that’s the factor inherent in the patients’ caregivers.

The Missing Element of the Caregiver

While the shift to greater patient centricity in clinical research shows promise, valuable benefits to the success of trials can also be gained through consistent, thoughtful focus on caregivers. Caregivers (also known as carers, caretakers, or guardians) provide direct care to the chronically ill, elderly, or children. They can be parents, relatives, and other individuals who are the support system for the patient.

In the U.S., there are nearly 40 million caregivers providing care to the 16.6% of American adults aged 18 and above who have a disability or illness. This percentage is similar or higher depending on the country selected. For many patients, their quality of life—even their survival—depends upon their caregiver’s ability to recognize when they require increased or supplemental support and act as necessary.

A patient’s participation in a clinical trial often hinges on the caregiver’s ability to provide transportation for site visits, administer medication, and collect necessary data. This can make caregivers just as important a factor as the patient in determining whether that patient can successfully participate in a clinical trial from screening and informed consent through to its conclusion.

The quality and quantity of data collected for a clinical trial often are as dependent on the caregiver as on the patient. However, caregivers too frequently receive relatively little support and attention throughout clinical trials.

Key Issues that Create Caregiver Burdens

A major obstacle that makes it difficult for caregivers to help their patients participate in clinical trials is transportation. Simply getting the patient to the trial site can be extremely challenging. Not only can the patient’s disability make travel prohibitive, hours spent on the road or in the air may require taking time off from jobs or away from other obligations. Consequently, many caregivers who are working spouses and/or parents are unable to consistently bring patients to and from clinical trial sites.

For caregivers of patients suffering from disorders such as Duchenne muscular dystrophy, travel burdens can be particularly acute. Duchenne patients become non-ambulatory in their teenage years and require round-the-clock care. This makes travel in general more difficult. Since Duchenne is a relatively rare disorder, affecting approximately one out of every 5,000 live male births, clinical trials are limited in number and conducted at specialized medical centers around the country. Many families who do not live close to one of these centers may not be able to travel to these sites or take time off from work.

Caregivers also may be the critical factor in collecting quality data and adhering to a trial protocol. They may be required to provide a complete medical history of the participant at the onset of the study, as well as ongoing reports regarding medication schedules, adverse events, and patient data captured from monitoring devices. The trial’s efficacy may also depend on caregivers adhering to a strict schedule for administering medications and collecting/reporting data.

For caregivers whose patients are in extended trials, data collection and protocol adherence can be crushing obligations that may have severe adverse effects on their lives and mental well-being. In a 24-week, randomized trial to assess whether meditation would improve the quality of life and ease the psychological stress on caregivers of dementia patients, caregivers who were informed that free respite care would be provided to their loved ones while they were attending study assessments and classes were more interested in participating than caregivers who weren’t given this option. The latter group identified lack of respite as a key disincentive to enrolling in the trial.

How Studies Can Better Support Caregivers

There are several ways designers and managers of clinical trials can make it easier for caregivers to facilitate these studies.

Incorporate the caregiver role from the outset. The fact that caregivers are primary contributors of data for a clinical trial should be made clear in educational materials at the beginning of the study. Their concerns and suggestions should be heard during the planning phase to ensure barriers to obtaining data are minimized or eliminated. If caregivers advocate for hybrid or fully decentralized clinical trials (DCTs), such preferences should be considered depending on study requirements.

Target caregivers in recruitment efforts. Research recruitment typically is targeted to patients, not caregivers. For many potential participants who are unable to search the internet for appropriate trials, their caregiver is the person who will reach out to the study team. It is important to keep caregivers in mind when developing recruitment strategies such as marketing to the right audience and providing study-based recruitment websites that can be easily found online.

Emphasize ease and transparency of the consent/assent. Provide a targeted consent/assent to the participant and to the caregiver with specific language for the caregiver, allow them to ask questions, and give them appropriate answers. This can be done during a telehealth virtual visit with the study team that includes all caregivers, so they receive consistent information at the same time as the study participant. Consent/assent can be collected electronically using any phone or tablet device. Allowing this to be done in a comfortable home setting eliminates any anxiety or complications associated with traveling to a medical facility.

Adopt and discuss the benefits of a hybrid or fully DCT approach. Explain to caregivers the benefits of hybrid and DCTs model compared to a standard clinical trial design, including frequency and ease of remote data collection, enhanced data quality, and decreased burden from eliminating or reducing some travel to trial sites. While these approaches may be new to caregivers and patients who have participated in trials featuring other designs, the use of mobile technologies and other practices to increase ease of participating will prove to be a selling point for studies.

Benefits of a Caregiver-Centric Approach

By improving recruitment practices and reducing barriers to participation such as required site visits, clinical trial leaders can improve study recruitment, engagement, and retention. They also can promote greater inclusivity and diversity of ages, races, and disabilities, which historically have been shortcomings in clinical trials.

A 2019 study published in JAMA Oncology analyzing 230 clinical trials from 2008 to 2018 that led to cancer drug approvals by the U.S. Food and Drug Administration concluded that “black and Hispanic races are consistently underrepresented compared [to] their burden of cancer incidence.” Improved diversity is needed in clinical trials and can be achieved as caregivers are better considered and supported.

When clinical trials put patients and caregivers at the center of their studies, they can improve the clinical research enterprise’s patient-centric focus with a positive impact on overall engagement, data quality, and research outcomes.

Jennifer Price is the Executive Director of Data & Analytics at THREAD. She has more than 25 years of clinical research management and technology implementation experience and is a Board Member and Secretary of the Society of Clinical Data Management.