PUBLICIS HEALTH'S ROLE IN CLINICAL TRIALS: Q&A WITH KLAIRA SIMON, MANAGING DIRECTOR, LANGLAND U.S.

Photo by Markus Spiske on Unsplash

By JohnMark Conklin, Global Communications Manager, Publicis Health

As we all anxiously await a treatment and vaccine for COVID-19, pharmaceutical companies across the globe are hard at work on clinical trials. In November, we learned that initial results from COVID-19 vaccine clinical trials have been successful—and the imminent approval of a vaccine has catapulted life-science companies like Pfizer and Moderna into the spotlight.

Historically, news and information related to clinical trials was relegated to the industry-specific publications within science and medicine, but the pandemic has thrust the world of clinical trials into the daily news cycle and cultural zeitgeist.

Clinical trials play an essential role in scientific discovery and medical advancement and you might be surprised to learn that Publicis Groupe plays an important role in bringing them to life. In this exclusive interview, I sat down with Klaira Simon, Managing Director, Clinical Trial Experience at Langland in the United States to learn more about clinical trials, common challenges patients face, and where we go from here.

Klaira Simon, Managing Director, Langland U.S., a Publicis Health agency

Before we dive into the complex world of clinical trials, can you tell us a little bit about your background and your new role at Langland U.S.?

Sure! My background is in psychology and biology and I have dedicated the last decade to understanding patients and developing and deploying marketing and communications programs that encourage people to participate in research studies, especially Phase II–IV clinical trials—more about those later. I have had the privilege of serving in a variety of roles and especially enjoyed leading product innovation and business development within a combination of standalone patient recruitment firms and contract research organizations—all with the goal of connecting patients with clinical trials.

I joined Langland U.S. as the Managing Director in July 2020. I was drawn to Langland because of its stellar reputation as a creative and strategic company comprised of dreamers, thinkers, and producers who also deeply understand the importance of clinical trial participation. My goals are to continue to grow Langland’s reputation amongst U.S. study sponsors, to expand and enhance our capabilities, and to continue to develop our incredible talent. Ultimately, I believe Langland is poised to shift the paradigms and give rise to new ideas more than any other competitor in the space, and I am excited for us to continue to contribute in this meaningful work.

How did you come to focus on a niche area like clinical trial communications?

I really stumbled into this career path right out of college, as I was referred to a dedicated clinical trial patient recruitment firm in Wilmington, NC, through a family friend. With my dual undergraduate education in biology and psychology, I quickly connected with the work we do and have grown to appreciate the challenges and the amazing opportunities clinical trial participation presents. I started as a junior account manager and then found my niche in leading new and innovative programs that showed potential to move the industry forward. What I believe keeps most of us in this industry is the combination of being seeped in science while also being hyper-focused on finding ways to better support the study participants and researchers people who make drug discovery possible.

 For those who have never been involved in one, can you describe what it’s really like for someone to participate in a clinical trial and how Langland supports that experience?

After reviewing hundreds of clinical trial protocols across various therapeutic areas, I can say that each participant’s experience is significantly different and varied. For someone with a life-threatening condition in which other available therapies have failed them, a clinical trial could represent their only alternative. For people with a rare disease or an unmet medical need, a clinical trial may be their only available treatment option. For many others, participating in research for a condition they experience is a way to directly and meaningfully contribute to improved outcomes for future generations, even if there is no immediate benefit to the study participant. In the case of COVID-19—a condition impacting all of us to varying degrees—clinical trials present an opportunity to bring life-saving treatments and vaccines that would bring an end to the global coronavirus pandemic.

Clinical trials are expensive, time-consuming, rigorous, and rife with challenges and barriers throughout the process—it takes a village to move a drug through this stage of development. At Langland, we partner with clients to help them understand and improve the patient experience. Since we launched our clinical trial offering, Langland has supported enrollment into more than 550 global clinical trials over the past 25 years.

Our role is to first understand each prospective study participant’s unique experience, motivations and barriers to trial participation. We then provide a suite of communications solutions, including educational content provided via study websites, print and digital materials, informed consent videos and study guides. In some instances, we also help to identify and recruit study participants from outside of the study doctor’s own database by conducting outreach campaigns made up of a mix of paid digital and traditional media, physician referral programs and advocacy group relations.

Research study communications are unique from other healthcare communications in a few ways, but most notably, they are almost always globally launched across multiple countries and languages. Langland has provided clinical trial communications in more than 70 countries and over 100 languages!

Additionally, clinical trial communications also are heavily regulated by both national and local ethics committees with defined review cycles. This means we have to prepare all of the campaign materials prior to launching the study and then need to be prepared to adapt them to each ethics committee review and approval cycles before they can be launched in country. Langland’s ability to deliver best in class communications within these unique circumstances is one of the reasons our clients come back to us over and again.

What are some of the common challenges or barriers you encounter when it comes to reaching and encouraging consumer participation in clinical trials?

Clinical research studies, by nature, require such a high level of scientific rigor that we find they are almost always burdensome for participants and researchers alike.

Common examples are that participants are likely going to be asked to discontinue taking medications for their conditions. Researchers need to see if the study drug is effective, and that is understandably difficult to do if there are other medications contributing to a condition’s progress. Another challenge is participants will not know whether they are receiving the study drug or a placebo, which will look like the study drug but contain no active ingredients. Researchers most often need to be able to compare a participant’s study experience to others in the study, which means some people will receive the study drug and some people will not.

Participants will also likely need to come into the clinic for quite a few more visits and assessments compared to the standard of care for any particular condition. This is because researchers need to both monitor safety and measure whether the study drug is having its intended impact on the condition. Finally, most studies will have an increased number of procedures and assessments, which can include more frequent blood draws, surveys and other procedures, like MRIs and ECGs.

Finally, the motivations and benefits for participating in studies can be pretty low depending on how groundbreaking or urgent the new treatment is for that particular condition. Participants will be provided with the data from prior studies conducted, but there really are no guarantees that the study drug will actually achieve its primary endpoints.

How has COVID-19 impacted current clinical trials? What sort of impact do you think it will have the future of clinical trial research?

In the beginning of the COVID-19 pandemic, many of us were excited to see that there is so much education and information around how and why drugs are developed. I also naively expected people would connect this experience with what happens when we don’t have the treatments we need. My initial hope was that people would feel motivated and inspired to do more about their own health and the health of others in our communities.

Unfortunately, current surveys have shown the opposite is true. People in the U.S., for example, are sharing they are losing trust in our scientific communities and believe clinical trials are “not safe” and “would not participate.” While we don’t know all of the reasons behind these beliefs, it could be that messaging around clinical trials is typically controlled by a rigorous ethical review process and limited to a scientific community with more intimate knowledge of the condition and the study. With clinical trial messaging for COVID-19 trials now being shared by the general public, including media and politicians, these communications controls are no longer in place.

Why is having diversity in clinical trials so important? How are clinical trials ensuring they represent a diverse population? 

Morally: Because every person, regardless of race or ethnicity, sex, age or socioeconomic status, should have equal access to healthcare. While we understand there is so much complexity to these broader healthcare issues, particularly in the United States, clinical research studies present an opportunity to offer access to medications right at the beginning of the drug development process. The vision and promise of clinical trial diversity is ensuring treatments designed with everyone who needs them in mind.

Scientifically: Rigorous scientific research, like the studies we recruit, is conducted in populations that most closely represent, or mirror, the communities in which the approved medication will actually serve. For example, COVID-19 is impacting a higher rate of African Americans than is represented in the general population. According to the U.S. census, approximately 14% of the population is Black. However, the CDC reports Black people account for about 25% of all people hospitalized with COVID-19 and are four times more likely to die from the disease compared to White individuals. That’s why pharma companies, like Moderna, conducting their large Phase III COVID-19 vaccine clinical trial in the U.S., are making it a priority to recruit representative percentages of people from minority populations.

At Langland, we recognize both the moral and scientific obligation of ensuring diversity in CTE and have appointed Angela Rochelle, head of diversity initiatives, to help advise and proactively address common barriers for underrepresented communities.

What is one thing you wish more people understood or recognized about clinical trials?

When someone opens up their medicine cabinet, I encourage them to picture the hundreds of people willingly volunteering their time and energy to test and measure that drug, so that we and our loved ones can now take it with confidence and hopefully benefit. It’s important for all of us to understand that the medications we have access to today are a direct result of someone, usually hundreds of thousands of people, that were willing to participate in a clinical research study.

I also want people to know there is an entire industry of passionate, dedicated and ridiculously smart research professionals who are working on advancing medicines and bringing better treatments to our world.

Working in this field has allowed me to develop a deep respect for what research professionals are doing for our world every day, and I have an even greater admiration for those who have participated in clinical trials, improving the health of our world.

Klaira Simon joined Langland in August 2020. Follow Klaira on LinkedIn.

Langland is headquartered in London with additional offices in Windsor, New York, Singapore, and Sydney. If you’d like to learn more about Langland, you can visit the website or follow along on Instagram and Twitter.