The team at mdgroup, a comprehensive clinical research services specialist, focuses on helping clients execute clinical trials by offering a range of customized study services. Arthur Lazarus, who recently came on board as medical director, brings to the table a broad range of industry experience, which he will use in his mission to help expand the company’s mobile health offerings.
“Dr. Lazarus’ background in clinical development, patient safety, and medical marketing brings a wealth of experience to the mdgroup,” said Tarquin Scadding-Hunt, CEO. “Our philosophy is that if you start with excellence, you produce excellence, and I believe Dr. Lazarus will help us achieve even greater excellence in our mobile health services and beyond.”
At mdgroup, Lazarus said, staff endeavors to infuse a patient-centric approach to every step in the process that they touch, starting with recruitment, site engagement, patient retention, and clinical outcomes. What distinguishes the company, he said, is using the staff’s different perspectives—gained from working with a wide variety of organizations around the globe and coming from different backgrounds—and their prioritization of the patient.
“’Remarkable’ is a word that crops up quite a bit—our patients are remarkable, and we provide remarkable care—apart from the fact that there aren’t a lot of players in the decentralized clinical trial arena, to begin with,” he said. “They hire remarkable people, and they work effortlessly and tirelessly to ensure a remarkable experience and outcome for the patient.”
That patient-first approach is in line with Lazarus’ philosophy.
“My goal with mdgroup is to support all phases of the organization's operations that have an impact, or potential impact, on patient care,” he said. “They were beginning to realize that even though they're primarily involved in clinical trial operations or parts of the entire clinical trial, there was a need for medical understanding and services, which is why they wanted to hire a physician.”
Lazarus said he works about 15 hours a week with the company but is nevertheless very involved, starting with the RFP process. He reviews protocols to ensure they're medically sound and appropriate, that the goals can be feasibly accomplished, and that mdgroup is able to deliver what they are contracted to provide.
Additionally, his perspective as a physician has driven home the importance of staffing trials with qualified personnel, appropriate for the condition at the center of a study.
“One of the challenges of decentralized clinical trials is to make sure you have the same level of specialization,” he said. “Some of these trials require very detailed exams, and they're associated with specific questionnaires that could impact primary or secondary outcome variables—not all providers are created equal, so we need to source the correct health care provider for that.”
While Lazarus has observed and experienced a great deal over the course of his career leading up to joining mdgroup, now is an interesting time in mental-health drug development, he said.
“In terms of psychiatry and mental health right now, we are facing glorious opportunities in the field that we haven't seen over the last half-century,” Lazarus remarked. “Especially in the area of depression and major depressive disorders, for the last several decades, it's really been only a couple of different classes of drugs, on the market, all acting very similarly.”
Overall, though, he believes the field warrants more attention and respect.
“Having seen the whole field of mental health, it’s become a stepchild of medicine,” he remarked. “It's an afterthought, and it's not funded well at all—its consequences are under-recognized and undervalued—not only in terms of the patients, but the workforce itself, such as healthcare providers, physicians, and others.”
One reason Lazarus believes the industry should pay closer attention to the patient at the center of the system, especially regarding their mental health, is that the treatments they receive for their conditions frequently impact their mental state.
“Anyone faced with a chronic medical problem to some degree has an emotional response to that, and that has to be dealt with,” he said. “About one out of five patients with a chronic medical disorder at some point in their time may develop a major depressive disorder, so there's a significant interplay between general medicine and psychiatry.”
And, Lazarus has observed that much of the rest of the overall clinical research and health industry could stand to be improved in terms of a patient-focused approach.
“People in the US have been talking for a decade or more about patient-centric care, and building the healthcare system,” he remarked. “Instead, we’ve become so specialized, even super-specialized, that now patients are falling through the cracks.”
What’s more, he said, the level of conversation about the importance of increasing patient population inclusivity may not match what has been achieved.
“There’s an elephant in the room—with diversity, and inclusiveness, clinical trials have not done a great job in that area, and we’re keenly aware of that issue,” he said. “There has been a mismatch in many clinical trials, in which the populations they are studying are not representative of the disease in question. That calls for more significant Black and African American patients, Latino patients, Asian patients, etc., to be enrolled in clinical trials.”
The decentralized format, Lazarus pointed out, offers opportunities to reach these underrepresented populations because the studies can be brought to them, rather than forcing them to travel over potentially great distances to study sites.
Unfortunately, he commented, he has observed that achieving diversity and inclusiveness in patient populations often is given lower-priority status.
“It's just many times the path of least resistance to just enroll patients—any patients that you can put your hands on and enroll, so the higher-order goals of diversity and inclusiveness are sometimes overlooked or sidestepped to order to quickly enroll patients and accomplish the timeframes of clinical trials, in which speed to market is everything,” he said.
At the 2022 Summit for Clinical Ops Executives (SCOPE) gathering in February, Lazarus presented on The Proper Selection of HCPs for Remote Patient Visits. During the event, Lazarus remarked he felt encouraged by the event’s emphasis on the patient, especially as the industry moves toward its post-COVID phase.
“Now we are returning to something akin to normal business, there’s a growing realization of the benefits DCTs can offer, such as expanding participation and increasing diversity, as well as the potential pitfalls associated with reducing face-to-face site visits – namely, a disengagement with the protocol which can contribute to poor retention,” he said. “This year’s SCOPE recognized this crucial point.”
Going forward, Lazarus said, he will endeavor to support the company’s efforts to expand its DCT services and to keep the patient at the center.
"Advocacy cuts across the entire organization—it’s a key role not only for me but the entire employee workforce,” he stated. “That's what we're all about.”