What is patient centricity in clinical trials?

At Antidote, we consider the patient voice in how we think about the entire clinical trial process. From recruitment to randomization, the patient journey is a driving force in all that we do — and we think this strategy is helpful for clinical trial sponsors, as well. Designing treatments, clinical trials, and health solutions around patients is practicing patient centricity, and it can have key benefits for everyone involved.?

Gathering feedback from real patients and implementing that feedback into the work your organization is doing can make your trial more appealing to potential candidates — and this can result in better clinical trial patient recruitment, study enrollment, and participant retention.

What does patient centricity mean for clinical trials?

Many clinical trials have difficulties with both patient enrollment and retention. It’s been found that 80% of trials struggle with enrollment , and some studies estimate that up to 30% of patients who join a clinical trial ultimately withdraw from the study.

Keeping the patient perspective in mind during the design and execution process can help this tremendously. At each stage of a clinical trial, from design to enrollment to retention, there are several ways to put the patient first.

Patient centricity and clinical trial design

The overall design of a clinical trial is one of the most important factors in the patient experience, so it is a key place to implement a patient-centric strategy. By proactively learning more about what would make a trial appealing to patients, sponsors can set their study up for success from the onset. Here are a few ways to give patients a voice in your trial design:

Host a patient group. The best people to speak to about how a condition impacts the day-to-day lives of those who have been diagnosed is the patients themselves. By talking directly to patients, sponsors can glean valuable insights into the kinds of treatments that would help patients the most, as well as any specifics about symptoms or quality of life that might make certain trial designs cumbersome for participants. For those interested in working with a patient group, the Clinical Trials Transformation Initiative has resources that can help.

Try a live protocol simulation. AstraZeneca is credited with hosting the first clinical trial simulation to measure patient sentiments , which took place in 2017 for individuals diagnosed with lupus. Patients were able to provide feedback, resulting in 60 recommendations on how to improve the experience. Insights like these can be extremely useful for sponsors, and sharing the results of the protocol simulation as one of your clinical trial recruitment strategies can show patients you are keeping their insights in mind.

Work with patient advocacy organizations. If you’re unable to host a patient group, collaborating with patient advocacy groups and nonprofit organizations can also offer valuable insights into the patient experience. Partnering with these groups can open up dialogues around where needs are not being met and provide a learning opportunity regarding how patients might respond to the logistics of your trial. Working with these groups can also help build trust within the organization’s community, which can set your trial apart when recruiting patients.

Use real-world data. When designing your trial, evaluating data from previous trials or trial searches can provide insight into protocol issues that may have hindered past research. These often include eligibility criteria that is too difficult for the average patient to meet, recruitment strategies that aren’t inclusive, or site protocols that put an unnecessary burden on the participant, resulting in difficulties getting patients to randomize.

Patient centricity and clinical trial enrollment

When the time comes to start enrolling patients, consider the randomization pipeline from the patient perspective — this is where it can be helpful to work with a recruitment company that has experience getting feedback from patients themselves. Some other helpful tips:

Keep health literacy in mind. According to a study conducted by the Department of Health and Human Services, only 12% of Americans are “health literate.” When drafting recruitment and site materials, it is helpful to understand the language patients use to talk about their condition, instead of exclusively using clinical terms. While a medical researcher or health care professional might use certain verbiage in a clinical setting, that might not be the terminology that will resonate with patients in advertisements and outreach materials.

Communicate as much as you can in your ads and landing page. In our survey of 4,000 patients regarding the clinical enrollment process , patients reported that their key motivations for participating in research include:?

• Access to a drug, therapy, treatment, or device that could extend life or improve quality of life
• Reimbursement for time and travel
• Receipt of health care at a free or reduced cost?

In your outreach materials, including copy that speaks to these motivators can help you reach the patients for which these factors matter. On the study landing page, it is also helpful to include practical details such as the number of study visits, whether or not overnight stays will be part of the trial, and if travel costs will be reimbursed. Giving patients more information early on can help them make an informed decision about whether or not the trial is a good fit for their lifestyle.

Patient centricity and clinical trial retention

Patient engagement is one of the most important factors when it comes to retaining trial participants. Patients may withdraw from the trial at any time, and patient dropouts can be a costly problem for sponsors — but these tips can help:

Choose sites that offer scheduling flexibility. Understanding what day-to-day life is like for your patient population can help you think through how best to select sites that can fit in with an average participant’s schedule. For example, some conditions may cause patients to require more time to get to the site, meaning appointments later in the day could be helpful; other conditions may primarily impact people of working age, which means evening or weekend visits might be preferred.?

Consider a decentralized trial model. During the height of the COVID-19 pandemic, many researchers got creative by trading traditional processes for virtual or decentralized opportunities — and that trend has continued through to today. Decentralized trials have many benefits , including:

• Reduced exposure for participants, many of whom have conditions that make them especially vulnerable to COVID-19, the flu, and other communicable diseases

• Fewer required site visits, as many check-ins can be done via a telemedicine appointment and eliminate the burden of traveling for patients
• Lower barriers to recruitment, as a virtual study makes location less of an issue, allowing a clinical trial recruitment company to cast a much wider net during outreach?
• Higher data quality, which can be provided through technology like wearables, which provide real-time, continuous information in lieu of self-reporting or small snippets of vitals from site visits

Solidify your team of lab partners. Having a single, central location for sample collection will inevitably exclude participants from your trial, even if travel reimbursement is offered. Working with a direct-to-patient lab vendo r or their recruitment company partners can allow you to safely provide participants with access to lab and diagnostic services at a location convenient for them.?

Make it easy to get to study sites. Arranging transportation for patients can make a big difference in enrollment and retention. Sponsors or sites often partner with rideshare services to coordinate rides to site visits free of cost, or provide a stipend to participants to cover transportation costs such as gas, mileage, and mass transit fares. Depending on the number of sites, the rareness of the condition, and the length of the trial, it may make sense to pay for air travel as well.

Create a communication toolkit. A communication toolkit, written with the patient audience in mind, will include basic information about what a participant can expect from the trial and set clear expectations for required time commitments. This can help educate patients about the trial requirements before enrollment to ensure they know what to expect during the duration of the study.

If you’d like to speak with us about how you can make your clinical trial protocols and recruitment more patient-centric, get in touch today .