The landscape of immunology clinical trials rarely stands still, from breakthroughs in scientific advancements to changing outlooks on trial dynamics and expectations. Dr. Ian Baird, a Remington-Davis (RDI) board-certified infectious disease physician who has conducted 262 trials over the last 37 years, shared his thoughts on recent trends in clinical trials that are shaping this growing area of research.
Taking a Patient-Centric Approach to Clinical Trials
Enrollment, as sponsors are well-acquainted with, can be a big hurdle for immunology clinical studies. And even when study subjects do enroll, statistics show that an average 30% drop out. At RDI, we take every possible measure to make sure participants stay engaged so clinical trial timelines stay on budget and on track.
One of the keys to retention, as we’ve demonstrated, is patient-oriented service. We have study participants who have been with us for many years, with 70% of our study volunteers having participated in a previous trial. The high level of service we offer starting at day one sustains our high retention rates.
Participant involvement is supported by flexible, no-wait appointments, sending out reminders and getting subjects promptly to our site. When necessary, we’ll provide transportation and operate outside of standard business hours to accommodate their needs. Meals are provided at no cost when an appointment is long or requires fasting labs. For situations involving a prolonged waiting period, such as with PK sampling or serial tests, we offer a private space that’s equipped with a recliner and other comforts.
From the moment a study volunteer steps inside our facility, the goal is to make them feel valued and supported. We want to make sure they remain committed to the study, so we can simplify the recruitment process for sponsors and produce high-quality data.
Participating in an immunology clinical trial or otherwise is voluntary. Study subjects don’t have to be here. As such, we aim to give them a home-like environment that includes Wi-Fi, beverages, food and other comforts to support a positive experience.
Flexibility is also an important part of our patient-centric approach. For years, we’ve employed the trending concept of decentralized clinical trials (DCTs), with the goal of simplifying processes for subjects. At RDI, if a study volunteer has a hardship, we are experienced at employing DCT principles to the sponsor’s degree of comfort. If a participant runs out of a study supply or misplaces it, we’ll come to them if stopping by the clinical site is burdensome.
Use of mRNA Vaccines Beyond COVID & Their Implications
mRNA vaccine technology was first conceived and developed decades ago. While plenty of research was done in that timeframe to advance the technology, COVID-19 created a unique situation. There was clear need to get an effective vaccine out quickly.
The clinical trials for COVID-19 vaccines were up and running fast. But, as the National Institutes of Health notes, “[M]ore than 50 years of public and private laboratory research laid the groundwork for the rapid development of these life-saving vaccines.”
While helping to save lives, mRNA vaccines represent a major breakthrough in immunology, genetics and other forms of treatment. In 2023 alone, there were four major mRNA vaccine trials related to influenza, genital herpes and melanoma. What’s more, of all the ongoing mRNA vaccine trials, 70% are in the infectious disease space.
The COVID-19 vaccines have opened up new doors to once elusive therapeutic opportunities. As new treatments for infectious illnesses and diseases are tested to meet FDA requirements, RDI looks forward to the opportunity to participate in these clinical studies.
Alongside research advancements, trustworthy information about mRNA vaccines has become more accessible. Originally, there was some skepticism around how COVID-19 vaccines got to the market so fast. With more insights into the years of experience behind mRNA vaccines as well as their lower risk profile, it’s expected that people will grow more comfortable with the idea of mRNA vaccines.
Infectious Disease Implications Related to Biologics Growth
When biologic medications first came out, their effects were thought to be similar to that of chemotherapy. While biologic therapies do have an immunosuppressive effect, we now understand the effects are not analogous to chemotherapy in severity or intensity.
Today, 80% of TV ads you see for medications are for biologic medications. There are also dozens — maybe even hundreds — of ongoing clinical trials for new biologic medications. These trials extend across all branches of medicine, with a primary focus in cardiovascular and immunological diseases. At the same time, biologics in the dermatology and neurology fields are showing a great deal of promise.
As we continue to move forward, the side effect profile of biologic medications is likely to decrease. In rheumatoid arthritis, for example, the long-term disabling effects of the disease have become more manageable, with an overall minimal negative impact from the use of biologics.
As with mRNA vaccines, we are in the infancy of discovering the uses and benefits of biologics. We’re excited by the possibilities that both offer for new therapies that could save lives and increase quality of life, especially in patients with intractable or idiopathic diseases. Post-FDA approval clinical trials will continue to support the improvement, expansion and optimization of these therapies. Guided by our patient-centric approach, we are eager to have a hand in helping to ensure the success of these kinds of studies.
Thank you to Dr. Baird for his thoughts on the latest trends in immunology clinical trials. If you’re looking for a site for your next immunology clinical trial, know that Remington-Davis has years of experience conducting these types of studies in a patient-centric environment. Request a consultation today.