Enhancing Clinical Trial Awareness and Experience for Patients and Caregivers: The Role of Sponsors and CROs

In every clinical trial, the role of patients and their caregivers is pivotal. Caregivers not only offer essential emotional support but can also play a significant role in helping patients navigate the complexities of their medical journey. As Sponsors and contract research organizations (CROs) seek to improve patient experiences and broaden their outreach, it's crucial to recognize the unique and important role caregivers play in clinical trials.

Understanding the Needs of Patients and Caregivers

Perspectives from a caregiver and clinical trial professional

Prior to entering clinical research as a profession, I had experienced the impact of a clinical trial through my Dad’s glioblastoma diagnosis. The patient journey can be overwhelming depending on the diagnosis and in my experience, there were many healthcare professionals we interacted with frequently. The oncologist served as a critical component when evaluating treatment options and provided us with information on available clinical trials to cutting edge therapies and how they may compare to the current standard of care therapy. The clinical trial my dad participated in resulted in a substantial decrease in tumor size, nearly eliminating the entirety of his tumor, and increasing his overall quality of life.

Awareness

Patients and caregivers need to be aware of clinical trial options. Without knowledge, they cannot make informed decisions about participation. This begins with open communication between the patient, their caregivers, and their healthcare providers. Caregivers can often act as advocates, helping patients explore various treatment possibilities, including clinical trials.

How can sponsors and CROs help?

• Physician/PI Relationships/Engagement: Sponsors and CROs can foster relationships with physicians, Principal Investigators (PIs) and Key Opinion Leaders to ensure that they are well informed about available clinical trials. This knowledge empowers healthcare providers to discuss trial options with patients and caregivers.
• Site Network: A well-established site network enables sponsors and CROs to disseminate information about clinical trials effectively. Engaging with sites experienced in clinical research facilitates better patient and caregiver outreach.
• Targeted Recruiting: Tailored recruiting strategies help identify suitable candidates for trials, ensuring that patients who could benefit most are made aware of trial opportunities.

Education

Finding the right sources of information and understanding the details of clinical trials are essential for caregivers and patients alike. Engaging with clinical research requires comprehending the risks and benefits associated with participation.

How can sponsors and CROs help?

• Patient and Caregiver-Friendly Materials: Sponsors and CROs can develop educational materials that are easy to understand and tailored to the needs of caregivers and patients. These materials should provide clear information about clinical trial processes, potential risks and expected benefits.

Reduced Burden

Participation in clinical trials can be burdensome for patients and their caregivers, especially if they are already dealing with a serious medical condition. Sponsors and CROs can make efforts to minimize this burden, making participation more feasible.

How can sponsors and CROs help?

• Feasibility: By conducting feasibility assessments, sponsors and CROs can identify potential challenges and provide support to address them. This can include assessment of the patient and caregiver journey from diagnosis to treatment, addressing logistical concerns, minimizing travel requirements, and offering additional resources to alleviate the burden on caregivers and patients.
• Trial Design Input and Guidance: Considering both patients and caregivers in the trial design allows sponsors and CROs to consider the unique perspective of those directly affected. Often patient advisory boards are an integral part of the protocol development process, in addition, caregivers feedback can also be sought given their impact on the patient journey. This can lead to the creation of more patient and caregiver-centric trial protocols, making participation more manageable.

The Value of a Skilled CRO Partner

To achieve these objectives, it is crucial to partner with a CRO experienced in improving the patient and caregiver experience in clinical trials. A skilled CRO partner can offer:

• Experience: A track record of a proactive patient and caregiver-centric approach which brings valuable insights and strategies to engage patients and caregivers effectively.
• Relationships: A network of strong relationships with healthcare providers allowing for efficient communication and outreach.

In the world of clinical research — where recruitment is always an issue — patients and their caregivers are invaluable and necessary partners. Biopharma sponsors and CROs have a unique opportunity to increase clinical trial awareness and enhance the overall patient experience by engaging with caregivers. By recognizing the specific needs of caregivers and patients, offering educational resources and reducing the burden can facilitate greater participation in clinical trials, ultimately advancing medical research and improving patient outcomes.