Healthcare Intelligence 2020 Brandon Early Editorial Article Header v1r1

Brandon Early has an intimate knowledge of clinical trials. Over the years, he’s built an impressive resume as a leader in clinical research and possesses years of hands-on experience and expertise in the field. Coming from a medical family, he saw firsthand throughout his life how those in healthcare have the power to heal people and make lives better. He knew early on this was the career path he would follow.

Brandon earned his undergraduate degree in biology and a Master’s in clinical research from the University of Virginia. He began his career serving as a clinical trial coordinator for an allergy and asthma doctor. From there, he worked his way through various oncology project management positions for a contract research organization (CRO), and then joined a small biotech company. His career path ultimately led him to PRA Health Sciences, where he was first tasked with starting PRA’s Global Drug Development group. Today, he serves as Vice President for Project Delivery.

While he obviously has the credentials, background, and wide-ranging experience in clinical research, Brandon’s unique and personal insight into clinical trials comes not just from this training and on-the-job experience. Early in his career, he participated in a clinical trial as a patient. So when it comes to clinical development, he has the ability to not only approach clinical trials from the perspective of an executive at a leading CRO—he knows intimately what patients may be feeling.

This experience as a patient continues to drive how he approaches his job to this day.

Hands On, Personal Touch

Brandon began his clinical development career in the lab conducting basic science research. In this role as clinical trial coordinator, he was very much on the frontlines, analyzing blood samples from patients enrolled in clinical trials and studying the signs and symptoms they were experiencing. It was here that he began to tap into his instinct and ask his own questions about what he saw. For example, if he noticed what appeared to be a pattern, where a number of patients all seemed to be experiencing something similar, he’d recommend writing another protocol to further study these occurrences.

In addition to what he learned about a patient’s condition in the lab, it’s what he saw in their faces that equally moved him. When enrolling patients in clinical trials, coordinators have the opportunity to develop a relationship with a patient from the very outset and help shape their journey. Brandon sat down with patients and talked them through what the experience would entail. From this earliest informed consent stage, he personally connected with the patient, looked them in the eyes, saw their facial expressions, and got a read for what they were understanding and feeling, whether uncertainty, anxiety, or fear. Brandon notes that as a clinical trial coordinator, he simultaneously served several trusted roles for patients—he was part life coach, part nurse, part therapist, and part shoulder to lean on as he supported them throughout their journeys.

Both clinical trial coordinators and nurses also develop the keen ability to look at a protocol and foresee what is going to be required of a patient during a given visit to the clinic, and make it as burden-free as possible for them. In addition to meeting with a doctor, a patient—who may be feeling bad and extremely tired—could have multiple procedures scheduled such as blood work, a CT scan, and lung function tests. Logistics of a multidisciplinary appointment can be challenging, but Brandon’s experience enabled him to plan the day, envisioning exactly where to walk the patient and make each step as efficient and easy as possible.

A Personal Perspective

Brandon unquestionably has a unique and personal insight into clinical trials, likely more than even many of his colleagues in the field. This special knowledge not only comes from the typical on-the-job experience of someone who has worked their way up to vice president at a CRO – at the same time he was cutting his teeth and learning about protocols as a clinical trial coordinator, he participated in a clinical trial as a patient. Through this participation, he learned a lot more than he may have bargained for—such as how patients should not be treated.

At 23 years old, Brandon entered a clinical trial for a relatively routine indication. During the time he was taking part in the trial, he began experiencing headaches so intense he wound up at the hospital. During an eight-day stay, he learned he had developed a brain clot. When he contacted the doctor serving as principal investigator for the trial to see whether the investigational drug could have caused the clot, the doctor brusquely replied there was no way the medicine was involved—and then hung up on him.

Brandon describes this unacceptable “bedside manner” of the doctor and how he refused to even entertain the idea that the drug could have been involved as inherently wrong. The negative experience is something that he carries with him today, not as a chip on his shoulder, but as a reminder. Doctors, scientists, researchers, and anyone involved in a clinical trial can never get so wrapped up in the operational side of clinical research and looking for the results that they’re expecting that they forget there are patients—real humans in need—on the other side. These patients have put an enormous amount of trust in them and are hoping for an outcome that will change—even save—their life.

“If we’re selecting and qualifying and working with physicians that aren’t after the true spirit of drug development and making the best choices for patients, now and in the future, then we’re doing something wrong,” says Brandon.

Innovative, Not Impersonal

As with most industries, innovations and technological breakthroughs have changed the face of clinical research, especially in recent years. Although Brandon’s participation as a patient is not too far in the past, remarkable advances in technology have streamlined clinical trials—for patients and investigators—since the days of strictly pen and paper processes, faxing volumes of pages, and not even having email as a resource to communicate.

Even today, terms such as Artificial Intelligence (AI) and virtual technology still sound more like science fiction to some people than actual, viable healthcare options. They’re just futuristic, lofty goals that haven’t been realized in clinical development yet, so they don’t impact studies, researchers, or patients. Right?

Not at all, Brandon says.

These advancements are real, and they’re being put into practice everyday in today’s modern clinical trials. Brandon notes that all trials today are impacted to some degree by miracles of modern science. Certain trials look and are conducted completely differently than in the past, while others will employ at least some new innovations and way of doing things at some stage of the trial.

Breakthroughs in AI and virtual technology, in addition to wearable technology and mobile health platforms, have revolutionized clinical trials—and PRA has been at the forefront of this movement. Unheard of just a few years ago, we have the ability today to do essentially everything that was traditionally limited to a physician’s office or clinical site virtually. We have the capabilities to educate patients, gather electronic informed consent and e-signatures, complete patient reported outcomes, and provide feedback to the patient right from their phone.

Wearable devices, such as activity trackers and sensors, allow patients to participate in a trial from the comfort and convenience of their own home. While they go about their daily routines, investigators collect raw patient data and monitor vital signs in real time. This is true even for patients with diseases and conditions that traditionally rely on high-touch care, such as those within the oncology space, who can utilize the new tools and technology to greatly reduce their trips to the clinic or the time they are required to spend there.

Additionally, telemedicine and virtual healthcare provide patients with convenient access to medical professionals and medical care by phone, video, or app around the clock.

While certain clinical trials can now be conducted virtually with most processes automated, Brandon is quick to point out that operationally, there will always be a need for an in-person component to clinical trials. PRA has built a foundation on patient-centric services and delivering hands-on personal care to those in need. These technologies won’t replace the expertise, compassion, and human touch patients receive from PRA—they will enhance all we have to offer and allow us to be more productive and efficient while doing things more intelligently.

In short, PRA will never totally “turn off the light” to our existing trial structure and the current way of running clinical trials. We will in effect “upgrade the light bulbs” and turn on the lights of virtual trials, achieving greater efficiencies and making it easier for patients to enroll and participate in clinical trials.

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