The Benefits of Community-Based Clinical Trials

/in , /by

May is National Cancer Research Awareness Month and the ideal time to explore the crucial role clinical trials play in the field of oncology. Thanks to ongoing research and discovery, the industry has witnessed a host of medical breakthroughs, including development of new medications and therapies that can advance cancer treatments and help better the lives of cancer patients.

Community-based research offers a notable advantage to smaller, independent practices primarily due to one factor: patients do not have to travel far to participate in a clinical trial, which can boost enrollment and advance scientific knowledge.

While this helps practices overcome one of the greatest hurdles to getting clinical trials off the ground, they must still be well-prepared and properly equipped before moving forward—and most will benefit from a partner capable of streamlining their efforts.  

Trial Prep

Conducting clinical trials, whether in a lab or a small practice, is not for the faint of heart. First, physician groups need to catch the eye of clinical trial sponsors, who tend to gravitate toward larger practices with more expansive patient pools. The best way to do this is through a proven track record, which of course requires successful completion of at least one study.

Training and education are also required. Physicians and research professionals interested in running a clinical trial must undergo mandated training through the FDA’s Office of Good Clinical Practice (OGCP), which must be updated on a regular basis. And though not required, it is important that clinic staff on both the administration and clinical sides of the house be educated on the nuances of conducting a trial. This will help ensure compliance with required protocols.

Also, while many clinical trials have similar administrative requirements, oncology-focused research is unique because patients are facing a life-threatening illness. Not only is it more difficult to identify the right pool of potential participants, it also requires the right tools and extra time to ensure they are fully informed and able to make educated decisions about their involvement.

Through consent forms and in-person meetings, physicians need to work one-on-one with the patients to outline clinical protocols, risks, and benefits of the trial. It’s important for patients to understand that they are under no obligation to take part in any clinical trial and can withdraw at any time and for any reason. This is true for any trial – but because oncology trials involve severe and life-threatening illness, it is especially important to be candid and thorough with cancer patients.

Practices should also be prepared to dedicate additional resources for the increased administrative tasks, particularly patient-related documentation and record-keeping that accompany clinical trials.

Streamlined Partnership

Partnering with a network such as the American Oncology Network (AON) can streamline the clinical trial process, making it possible for independent practices to play a role in advancing cancer therapies. We not only support the heavy lifting on the administrative side, but also supply expertise and technology to help practices host more complex and, ultimately, more successful trials. For example, we bring to the table the equipment necessary to assist with blood and tissue sampling and testing, which allows practices to carry out certain trials that would otherwise be out of reach.

One of our most unique assets to a practice, however, is the ability to take a patient’s molecular characteristics and match them with a specific clinical trial. We use technology to help us identify those patients that match a study’s criteria and would potentially benefit most from participating. For example, use of EHRs and other systems enables us to match patients with trials based on criteria such as molecular defects or a change in tumor type.

Through AON’s streamlining efforts, we can help practices conduct their own trials, regardless of size, and help build their research programs. When it comes to community trials, working with AON provides access to over 35 years of expertise to assist in this area.

We also offer a high level of flexibility that lets us support practices engaged with clinical trials when the unexpected happens, like the current pandemic. COVID-19 has put a temporary hold on enrollment for some trials because of an inability to supply certain drugs, while others have paused their trials because patients aren’t able to travel or come in for regular lab work and other assessments required in all trials.

At AON, however, many of our trials are still up and running because they can operate remotely. Physicians and clinical trial coordinators within practices can securely access patient records and meet with trial participants via telehealth. Through the pandemic, we have worked closely with our research partners to make sure they can continue all required monitoring of our research through secure remote access.

The Case for Community

Community-based clinical trials come with many benefits for independent practices. They enable patients to be matched with potentially life-saving research while staying within the comfort and familiarity of their oncologist’s office. Because this can accelerate enrollment, community-based trials often yield faster results—helping to move the science forward.

But running clinical trials can be an arduous and resource-intensive process. A network like AON, with its technology and decades of experience, can help streamline the process, putting clinical trial work within reach of even the smallest practices.

Addressing Oncology Care Continuity During a Public Health Crisis

/in , /by

Crisis situations often call for creative solutions in healthcare and lean on the true strength of provider-patient relationships. While the stress of the COVID-19 pandemic is experienced across all walks of life, those with chronic or life-altering illnesses face unique challenges.

Care delivery for these patients cannot be put on hold. When dealing with a health crisis of such monumental proportions, oncology practices must identify ways of keeping patients safe and on track to achieve optimal outcomes. For cancer patients, the best approach ensures the full spectrum of care is addressed, including treatment, nutritional and emotional support.

Rolling with the Changes

Amid stay-at-home and social distancing orders, oncology practices remain essential and cannot simply shut their doors. Instead, providers need to adapt the way they run their practice while still maintaining continuity of care.

Our providers at American Oncology Network (AON) have deferred non-critical visits, such as six-month and annual follow-ups, but are continuing to see patients who are undergoing treatment or are newly diagnosed. In addition, we check with patients prior to each visit to determine if they are experiencing any symptoms associated with the virus – such as fever, cough, shortness of breath – and require they wear a mask to their appointment. One AON practice in Columbus, Ohio, screens patients for symptoms in a tent outside their facility before allowing them inside. All staff members have their temperatures taken daily, before and after each shift, and non-essential visitors are required to wait outside the clinic.

Amid industry shortages, our procurement team has done a tremendous job of ensuring our practices have the supplies they need to keep their facilities clean to ensure the safety of our patients – even going “old school” to overcome the lack of pre-packaged disinfectant wipes by utilizing paper towels and  FDA approved cleaning solvents.

The Rise of Telehealth

Telehealth, which allows patients and physicians to communicate through videoconferencing, is experiencing a significant surge in utilization – not only because the COVID-19 pandemic has made it a necessity to conduct patient appointments remotely, but also because the Centers for Medicare and Medicaid Services has relaxed reimbursement requirements, with many commercial plans following suit. Telehealth is expected to remain popular even after the pandemic is gone.

Our physicians understand the benefits of developing personal relationships with each of their patients, which typically begin with a face-to-face visit. Over time, however, as the bond between doctor and patient grows stronger, telehealth may become a very viable alternative where appropriate. This current health crisis has simply accelerated its acceptance and adoption. And while there are some long-term issues to figure out, the COVID-19 pandemic has taught us that telehealth is essential to maintaining patient access to high-quality care.

Unfortunately, as could be expected, many small, independent community practices lack the IT expertise, bandwidth or technology to implement telehealth quickly enough to effectively serve their patients. Thankfully, because of the existing infrastructure and technical expertise at AON our growing network of more than 130 providers was able to offer virtual appointments via telehealth to their patients within a span of four days and all locations are conducting these types of appointments daily.

Compassionate and Patient-centric

While telehealth has become an essential part of practicing medicine, our practices haven’t lost sight of the emotional needs and mental health of our patients. AON addresses this through triage nurses and social workers proactively reaching out to patients suffering from depression or struggling with the isolation that comes with the current social distancing measures.

I cannot stress enough, especially under these circumstances, the importance of why we are in this business – to provide our patients with the best care possible.

Our patients are at the center of everything we do and every decision we make. Now, they need us more than ever. We are taking every possible step to continue providing exceptional care, safely and compassionately.