How Do Patients Choose Between Clinical Trials and their Standard of Care-defined treatment options?

Standard of Care or Clinical Trials: How Do Patients Choose Between Their Options?

Recently, in a conversation between Carole S. and me, this question popped up: how do patients choose between two options–the standard of care, on the one hand, and clinical trials, on the other?

The answer is both complex and simple. In this article, we’ll try to break it down to the basics.

Standard of Care and Patient Access

Standard of care is not just about access to treatments–it’s also about the process of obtaining that access. There are still huge disparities in accessing even basic medications outside of clinical trials and understanding a patient’s socio-economic status, demographic profile, and local healthcare infrastructure is crucial. These factors shape the patient journey and influence how patients experience healthcare as a whole and clinical trials in particular.

Clinical Trials vs. Standard of Care

When Carole had to weigh her options between the treatments her doctors suggested (part of the standard of care) and participating in a clinical trial, in the end, the decision hinged on survival. The clinical trial she was eligible for offered a potentially life-saving immunotherapy. However, whether she would receive the actual treatment or a placebo in the trial made her pause. Something the experts involved in the planning of trials need to understand is this: patients will always choose the option with the highest chance of keeping them alive.

A short video where you can listen to Carole's clarification.

Holistic Approach to Patient Care

Patients often have multiple chronic conditions that need to be considered alongside the primary disease being treated in the trial. Ignoring these conditions can lead to a lack of comprehensive care, potentially impacting the patient’s overall health and their ability to stay in the trial. A holistic approach means treating the entirety of the person with all of their accompanying conditions, not just the primary disease, which is the focus of the trial.

Video on why holistic care is so important for clinical research too

Motivations and Challenges

Feeling included and involved is a big driver for patients. While some patients might seek compensation for their data, others put more priority on the potential access to effective treatments. Which is why the availability of a newly approved and reimbursed treatment in their country could sway them away from an ongoing trial, depending on their health needs and desperation for effective treatment. When it comes to recruiting and retaining patients, the SoC (including newly reimbursed treatments) is your real competitor–not other trials.?

Global Variations in Standard of Care

There are stark differences in standard of care across countries. It is next to impossible to create a unified global standard due to the variations in healthcare systems and regulations. But while a global standard remains a dream, understanding these differences is crucial for designing effective clinical trials that cater to diverse patient populations.

Advice for the Experts Planning Trials

Talk to the patient. Engaging directly with patients to understand their needs, challenges, and standard of care experiences is essential for designing trials that are patient-centric and effective. This ensures that trials are tailored to meet the specific needs of patients, which ultimately improves participation and outcomes.

Hear the full conversation on the Trials with Maya Z podcast on Spotify, Apple podcasts and the other podcast platforms.