Clinical Trials Through the Eyes of Patients – Ten Things I Learned

I met Christine Von Raesfeld at the Outsourcing in Clinical Trials West Coast conference in February. It was clear right away that she was someone who was worth listening to. We struck up a conversation and agreed that when she was in Philadelphia in the spring for Eye for Pharma that we would get together. Fast forward two months and Christine, and another patient advocate Monica Watson, came to visit Greenphire at our office in King of Prussia, PA.

The discussion was eye-opening, and their insights were too good not to share more broadly. Improving clinical trial effectiveness can only happen with open dialog, and in this article, we hope to shed light on several key issues impacting the industry today.

Take a look, and weigh in. Do you have other issues that should be raised or items that can benefit patients as they participate in clinical trials?

1. Establishing relationships with elected representatives raises awareness of clinical trials.

Christine, who has participated in 5+ clinical trials, stays busy when she is healthy by advocating for patients in many ways. One of those ways is by collaborating with her Congressman. She lobbies regularly for patients’ rights both in her home district of California as well as in Washington DC. Christine’s congressman recently nominated her as one of Silicon Valley Business Journal’s Women of Influence (and she was honored with being one of their 2019 award winners) for her work in advocating for patients’ needs and pushing for change. It’s been a useful platform to elevate the disparate issues in the healthcare industry, and given that clinical trial awareness is often lacking, bring focus to ways individuals can participate in research.

2. Community is essential.

Monica, a former engineer, was diagnosed with Lupus nine years ago. Unable to continue her career, she has found purpose in helping bring together others living with Lupus through her work on behalf of the Lupus Foundation of America and the University of Pennsylvania. Since her involvement, the group has grown 300%. These individuals support each other and find strength within the community.

Community doesn’t always have to be in-person. Social media, including LinkedIn, Facebook, or even Facebook-Live, can help keep participants connected with fellow participants and industry professionals.

3. Understanding the motivation of clinical trial participants – hope and selflessness.

One especially poignant moment during the conversation was when the discussion turned to why many patients get involved in clinical trials, especially when their own chances of being healed are slim to none. Quite simply, they participate in clinical trials because they want to stop the disease in its tracks.  Participants want to prevent their children, their nieces & nephews, and all future generations from having to endure the same struggle.

4. Financial predicaments can impact a patient’s ability to participate in a trial.

Clinical trials can be a huge hassle and expense for trial participants. Many participants struggle financially as a result of not having a steady income. In Christine’s words, reimbursements are great, but only if you have the money to put out first. Providing pre-paid travel arrangements minimizes patient out-of-pocket expenses, greatly improving a patient’s ability to participate, and also reduces the logistical burdens associated with finding and booking travel arrangements.  

5. Access to trials can be limited based on where a patient lives.

Typically, trials can be accessed at a specialist medical practice, university, hospital or other research center. However, just because a patient has one of these nearby does not mean that clinical trials are available there. For example, a traditional HMO hospital has all the standard care expected (emergency rooms, maternity ward, operating rooms, etc.) but they are likely not dedicated to research and therefore unlikely to be offering any clinical trials. Even if some trials are available nearby, there may not be one that involves the specific disease or treatment arm required for that patient.

Therefore, many patients must travel significant distances to participate in trials (recent surveys show upwards of 70% of patients travel greater than 2 hours). This can be expensive, time-consuming, exhausting and ultimately a barrier that keeps patients from enrolling or causes them to drop out of clinical trials.

As we think of global clinical trials, there are other contributing factors that can impact the accessibility of clinical trials. For example, while India may be a populous country with the potential for high-volume testing – regulations have prevented widespread clinical trials. Individuals there who seek treatments through clinical trials may need to travel to other parts of the world or coordinate with groups like the Organization for Rare Diseases India (ORDI).

6. Participants want to provide feedback but are not sure how.

Providing feedback is often difficult. In the context of clinical trials, it can be even more burdensome. Christine mentioned that patients are often scared to be identified and regretfully are often faced with a stigma of being “sick.” Nonetheless, they push through because they want to improve the patient experience for everyone.

Christine has overcome many barriers and is an enthusiastic advocate of the patient voice in trials. In addition to speaking at conferences and utilizing social media, Christine sits on several patient advisory boards. Providing her input in terms of how patients feel and want to be treated during a trial is beneficial for all stakeholders and can positively impact current and future trials.  

7. Complexity of trials is overwhelming.

There’s so much to know and keep track of in a clinical trial.  Travel and payments, though only a small part of the complexity, can be overwhelming.  How will the patient get to the site? If the individual is working, can he/she take time off work? How quickly will the participant be reimbursed for their expenses? If the individual is getting compensated for the trial, is it considered taxable income?

Providing guidance and answers (along with managing the actual travel and payments) reduces stress for the patients.

8. Centralizing information is required for enhanced engagement.

Once you sign up for a trial, the amount of information that starts to arrive is significant. Emails and documentation flood in with important information on protocols, dates, privacy information and more. Quite frankly, individuals are inundated.

Centralizing information is incredibly helpful for easy recall and access. The fewer new systems a patient has to learn and/or the less places they have to look for information the better they are able to remain engaged in a trial.  

9. Companion care is not a “nice to have” for patients who participate in clinical trials.

Travelling can be exhausting, even when you’re a healthy individual. Now imagine the needs someone may have who is travelling for a clinical trial. Many participants, while healthy at the time, are just a setback away from an emergency. Having a companion along for the trip can bring comfort and critical knowledge/skills if facing an emergency.

Christine emphasized that a companion knows her symptoms and can spot them even before she may realize that a flare up is taking place. She often travels with other patient advocates, so they can support each other – potentially even administering medicine should the need arise. Sadly, traveling alone still occurs for many patients. Christine knows patients who have had flare ups and ended up in the Emergency Room – all by themselves.

Having travel brochures, 24/7 support lines, and pre-paid and pre-planned itineraries can help take the guessw ork out of traveling for clinical trials, but nothing can replace having a person there as a helping hand.

10. Clinical trials need to demonstrate empathy

Participants in clinical trials yearn for better treatments, even cures for their conditions. They give their time, energy and bodies to scientific discovery, yet their participation may be taken for granted. Patients deserve respect and communication – even a simple thank you. Improving the patient experience in clinical trials can be improved through additional services such as travel and patient payments, but gratitude can go a long way as well.

Thank you, Christine and Monica, for sharing your perspectives and for your work advocating for other patients. Thank you to all patients for giving your time and bodies to clinical trials. I hope that all of us together – patients, researchers, governments, advocates, sites, CROs, Sponsors, vendors, and anyone else involved – can continue to collaborate to improve the experience for patients and ultimately, with each of us doing our parts, bring better treatments to the world.