This is the fourth installment in a series on patient centricity in clinical trials (here are the first, second, and third in the series). Last time, we discussed a recent survey in which 88% of patients were at least somewhat willing to engage with researchers as they design trials. This installment focuses on some ways that research and development teams, clinical operations teams, and recruitment and retention teams can gather feedback effectively to ensure patient centricity in trial design.
Tips for Research and Development Teams
- Work with patient advocacy organizations. Depending on country regulations, working with patient advocacy organizations can also offer valuable insights into how patients will respond to both the purpose and logistics of a trial. The Clinical Trials Transformation Initiative has resources for those interested in engaging patient groups for trial design and execution.
- Reach out to patient influencers. Identify the biggest influencers in the space by looking at disease-related hashtags and practicing social listening. Then, get in touch to ask these influencers to weigh in on questions such as “What symptoms impact your life the most?” Depending on the therapeutic area and the influencer’s level of interest, this could involve inviting them to the office, speaking on the phone, or simply e-mailing.
- Try a live protocol simulation. This involves inviting patients in for a dry run of the trial appointments, and is a great way to discover if the protocol is acceptable to patients. For example, AstraZeneca recently hosted a lupus clinical trial simulation to measure patient sentiments; they received 60 recommendations on how to improve the experience.
- Use real-world data. Patient data from previous trials or trial searches can drive understanding of what may have slowed down past research, such as unrealistic eligibility criteria. This information can help predict what elements of a trial’s design might need to be reworked.
Tips for Clinical Operations Teams
We found 41% of our survey participants learn about clinical trials through online search listings. These listings are trial descriptions on websites like www.clinicaltrials.gov, www.antidote.me, and www.centerwatch.com; they are modern information sources for proactive clinical trial seekers to find the information they need. Website statistics confirm the popularity of this method of patient research; ClinicalTrials.gov receives nearly 200 million page views per month, and Antidote MatchTM is currently live on more than 200 patient advocacy websites.
As our survey showed, patients are searching, and including vital details in your study listing can make or break their decision to participate. Nearly 30% of patients wanted to know what procedures or drugs are being tested, and 25% needed to know the time commitment prior to being screened for a study. Other key details were “information about whether you will be able to stay on the drug after the trial” (15%) and “information about past trials of the procedure or drug being tested” (14%).
Clinical operations teams can make their trials more accessible to patients by finding and enhancing study listings beyond ClinicalTrials.gov, wherein listings are scientific and tend to be difficult for patients to understand:
- Look online. Online trial matching companies offer opportunities to enhance trial listings with these details. Companies such Emerging Med and my company, Antidote, seek to enhance their listings or provide their navigators with context relevant to patients.
- Connect with patient advocacy groups. Many advocacy groups have their own trial finder, such as The Michael J. Fox Foundation, or their own patient navigators, such as Lung Cancer Alliance. Providing information that will bolster these efforts makes it easier for these groups to help their communities navigate the trial landscape.
Tips for Recruitment and Retention Teams
The information patients need to make decisions, outlined above, should be prominent in the recruitment materials created by in-house recruitment teams or outsourced agencies. Here are a few ways to ensure this:
- Include as much information as possible in ads and/or landing pages. Patients are often altruistic and want to help, but they are worried about safety and how a study will fit in with their lives. Providing information that addresses those concerns in as many materials as possible is key.
- Include patients in outreach. A patient testimonial can help another patient picture themselves in the trial, so finding someone willing to speak about their experience can be very useful.
- Speak in plain English. Just 12% of Americans are “health literate,” according to a study conducted by the U.S. Department of Health and Human Services, so when creating materials, take reading level into account. Use images and infographics as much as possible, and tap into readability apps such as io or Hemingway App for reading level checks and recommendations on how to simplify content.
Get in Touch
We’d love to hear about how you’re taking patient decision-making into consideration while designing and recruiting for trials! Shoot us a note at firstname.lastname@example.org.
Author: Lisa Conroy, Director of Communications, Antidote
Related – The Patient Voice: Improving Patient Experience by Understanding Patient Perspective
Saturday, April 28 during ACRP 2018
In a global survey conducted in conjunction with CISCRP, TransCelerate Biopharma, Inc. found that the vast majority (94%) of patients and caregivers felt that being aware of clinical trials conducted in their community was important. However, 79% of respondents reported being unaware of clinical trials for the condition they were most interested in. Explore how a consortium of leading biopharmaceutical companies has been utilizing this survey and other feedback mechanisms, such as Patient Advisory Boards, to further understand the patient perspective as it works to close this gap and design additional solutions to improve the patient experience. Insights from this global survey will be shared in parallel with what TransCelerate is doing to decrease patient burden, enable better-informed patients, and improve clinical research awareness, study participation, and engagement.
Speaker: Jeneen Donadeo, Program Director, TransCelerate Biopharma, Inc.