By Christina DiArcangelo, CEO, Affinity Patient Advocacy
Until my father became a Stage 4 oncology patient in 2015 — and even with myself working as a pharmaceutical executive — I was unaware of the improvements needed in clinical trials. Many times, as pharmaceutical professionals, we try to develop clinical programs and products that will hopefully cure a patient’s therapeutic issue or at least reduce, if not cure, their symptoms. However, after observing some unsettling things with my father’s diagnosis and during his treatment, I vowed to affect change through my nonprofit advocacy firm, Affinity Patient Advocacy, and also in the clinical research work I perform daily.
My father had several physicians, including an oncologist who did not always speak with the other specialists working with my father. At one point, my father’s hepatologist gave him a medication that was interacting with another one of his medications, and my father experienced cognitive impairment. My father has always been very aware of what was going on and could easily navigate 150 pages or more in labor contracts that he negotiated on behalf of the Teamster members he represented. So when I noticed that my father seemed to be impaired, I spoke with his doctors to go over all of his medications. Upon doing so, we were able to see that he was having a drug interaction. If I had not been paying attention to his vitals and behavior, I am not sure how long this issue would have continued. I soon understood that physicians do not always coordinate with or speak about their patients with one another. It is unfortunate that these physicians do not see themselves as part of a team for the patient in the patient’s best interest.
Based on this and other personal experiences in and around clinical studies, I’m offering a few ways clinical trial leaders and organizers can improve the patient experience.
Reach Out To Patient Advocates
Patient advocates speak to patients daily and actively listen to what they are sharing. Often, the patients share feedback regarding current prescriptions and disease symptoms not necessarily found in literature surrounding the disease. They even share how they truly feel.
However, it is not uncommon for patients to feel like they are not heard. Most patient advocacy groups provide patients with a voice when they feel like they do not have one. A patient advocate is trusted by the patient, and obtaining the patient’s trust is critical for the patient advocate’s success. As trust builds, patients share more and more information that they may not even realize is important to helping themselves feel better and get better. All this information is critical to capture because many times patients have other ailments that are aligned with a disease that are not written about in any scientific journals.
In order to find patient advocacy groups to network with and establish a relationship with, you can conduct an internet search for patient advocacy firms or look to social media platforms such as Instagram, Facebook, and LinkedIn. Developing a thoughtful relationship with a patient advocacy firm and doing a deep dive on the therapeutic area will provide such a substantial amount of information that will support the clinical trial protocol development.
Consider Patient Experience During Study Design
Working with patient advocacy groups helps gather as much information as possible so a study design can consider the patients’ needs and feelings.
Being in a clinical study is scary to many patients because they are worried about many things, including:
- Will I be harmed by participating in the study?
- What are the known side effects of the study drug, and have they been truly captured?
- Has there been a lot of research performed previously with this study drug?
- Do I get paid for the study?
- What happens if the payment I receive for the study alters my ability to receive financial support?
- How long does a visit last?
- What happens to me if I want to stop for any reason?
- What happens to my participation in the study if something else happens to me medically and it is not related to the study drug?
- What will I have to remember to be able to participate in the study?
Often, these patients are also very sick and are concerned with their symptoms and don’t understand why they feel the way they do. Patients often wonder if they are ever going to feel better or even worry something else is going to happen to them related to their health. Some patients even feel as though they are a burden to their family and friends, and they feel alone, afraid, and isolated.
It is wise to consider the best ways to show support from the beginning to patients potentially enrolling in the study. I would strongly suggest considering the patient’s experience and preference when designing the following:
- How long the patients must be in the clinic
- If there are fasting requirements for visits
- How many visits the patients must attend and how often
- The design of the visits (lab draws, number of questionnaires, etc.)
- Consideration of the dosing requirements of the study drug and how to ensure that the study drug is being taken in a compliant manner
- Transportation to the study site
- The patient stipend, as many patients must take off work to attend visits
- Whether to provide food and/or entertainment if patients must attend long visits
- The number of procedures that the patients must undergo
In developing clinical trial protocols, many clinical researchers are eager to obtain as much data as possible for the patients but do not always consider how the procedures, labs, and visits impact the patients.
Create Easy And Accessible Study Materials
From the get-go, it is important to effectively explain the clinical trial process to potential patients, as well as when the patients agree to enroll in the study. Social media, television advertising, and print ads are all excellent trial recruitment tools. Sponsors must earn public trust, but it’s expensive to do so as there has to be staff allocated for educational purposes, consultants that understand the therapeutic area, and sometimes public relations campaigns to create.
Due to much of the failings in clinical research trials and design, patients do not always trust that they are being properly educated on clinical studies, as they’ve stated in surveys and to their patient advocates. Therefore, having very easy to understand IRB handouts along with visuals will help the patients better understand what they are committing to. It is always important to remember that patients are likely not educated about the clinical trial process or what to expect from being in a clinical trial. Remember, we need to ensure information given to patients does not provide them with a feeling of false hope due to the potential claims in relation to the study drug.
What’s more, the prescreening process must happen when the clinical trial staff or other outsourced patient recruitment vendors have adequate time to properly educate the patients regarding the clinical trial and, as mentioned above, really listen to what the patient has to say.
Some patients are scared about their disease and about trying a new drug that may or may not help them feel better. Clinical research and recruitment staff really need to slow down when communicating with patients. We must remember to always handle patients with a high touch approach and always meet them where they currently are with their disease and life.
About The Author
Christina DiArcangelo is an entrepreneur and CEO with more than two decades of experience in the medical cannabis, biotechnology, pharmaceutical, nutraceutical, and medical device industries. Through her role as board president and CEO of Affinity Patient Advocacy, as well as CEO of Spectral Analytics Precision Tele-Monitoring and founder/CEO of Affinity Bio Partners, Christina has been involved with revolutionary projects and global clinical studies that positively impact patients, including 25 FDA-approved devices, nutraceuticals, and biologics. Christina has spoken at many events, including delivering keynote addresses, and has organized her own education events for her multiple companies. Christina has a personal brand, I am Christina DiArcangelo, with a podcast channel, has launched an e-magazine called The DiArc, and has written as an opinion columnist for CEO WorldBiz.