Getting community-based oncologists to participate in clinical trials for new cancer immunotherapy drugs is not a hard sell. The new drugs, which stimulate the body’s immune system to fight cancer cells, can in some cases put people diagnosed with incurable malignancies into long remissions.

I often describe immunotherapy as a therapeutic lottery ticket. It’s true that the drugs work for just a minority of patients. But if you’re a patient in that minority, your disease is often brought under excellent control with some patients demonstrating multi-year remission with very few side effects.

Community practices in best position to advance immunotherapy research

Most community-based oncologists want to give that therapeutic lottery ticket to their patients. Until the recent FDA approvals, the only vehicle to do this was through a clinical trial. By enrolling eligible patients in clinical trials for new cancer immunotherapy drugs, oncologists are offering their sickest patients previously unavailable treatment options and a chance at returning to good health. Now even more innovative strategies for using immunotherapy and immune enhancement are entering the clinical trial arena in what might be considered the next generation of cutting edge cancer research leveraging the immune response.

Maximizing Immunotherapy Clinical Trials for Community OncologistsI believe that crucial role—advancing the development of new immunotherapy drugs by enrolling cancer patients in ongoing clinical trials—is natural for community-based oncology practices for two reasons.

1. Types of cancer: The cancers targeted by these new drugs are the most common forms of the disease and typically most prevalent in a practice’s community. They include breast cancer, lung cancer, melanoma, kidney cancer, bladder cancer and cancers of the head and neck. Patients diagnosed with these forms of cancer typically are treated by community based oncologists. It makes sense that the front gate to the clinical trials for these new drugs be the community-based oncology practice.

2. Volume: Pharmaceutical manufacturers need as many eligible patients as possible to test their new products, and the best source of that large pool of candidates is the community-based practice.

    Learn the basics of becoming a research-based oncology practice

    A large pool of willing doctors. A large pool of willing patients. And a large pool of willing drug makers. That’s the why. The question then becomes how. How do community-based oncology practices fulfill their role in advancing the development of new cancer immunotherapy drugs by participating in clinical trials?

    A number of professional resources are available to community-based oncology practices that want to enroll their patients in immunotherapy drug clinical trials. For example, the American Society of Clinical Oncology has compiled a comprehensive list of the  for starting a clinical research site. The topics covered by the ASCO include:

    • Learning the basics of community-based research
    • Building a clinical trial and research infrastructure
    • Drafting and implementing mission statements and policies
    • Maintaining research integrity
    • Complying with clinical trial regulations
    • Following good clinical research best practices
    • Adopting standard operating procedures
    • Marketing research programs to patients and drug makers
    • Engaging patients in clinical trials
    • Accessing clinical trials

     also has information for practices that want to join immunotherapy drug clinical trials. US Oncology Research has nearly 900 medical investigators working on new cancer treatments like immunotherapy drugs and approximately 300 clinical trials open for enrollment at any point in time.

    Five lessons for immunotherapy clinical trial success

    I’d also like to share some lessons learned from the oncology practices I’ve worked with on how to derive more value from immunotherapy clinical trials for both patients and practices.

    1. Continually stay educated on industry and clinical information
    Practices must continuously educate themselves on the availability of new immunotherapy drugs and the availability of related clinical trials for their patients. There are a number of tactics to do this, such as following the , which tracks immunotherapy clinical trials and has an easy-to-use search tool to identify trials for which a practice’s patients may be eligible. Another organization practices should follow is the National Comprehensive Care Network, which also provides resources for caregivers and patients, including a clinical trial . Education should also extend beyond the informational to the practical. Like all good clinicians, community oncologists should educate themselves and their staffs on the safe and effective administration of the new drugs. They must educate themselves on the potential side effects of the new drugs. Because the drugs alter the body’s immune system, other seemingly common and temporary illnesses may be signs of serious medical conditions that need to be addressed immediately. Oncologists should know the signs and treat their patients accordingly to give the new immunotherapy drugs the best chance of working.

    Maximizing Immunotherapy Clinical Trials for Community Oncologists 22. Maximize on the full value of clinical decision support tools
    Buying a static clinical decision support tool and integrating it into the practice’s EHR system isn’t enough. A practice should buy or license a clinical decision support application that’s continually updated just like the operating system on a smartphone or tablet. The applications should be regularly updated with the latest treatment options for different types of cancer, including newly approved immunotherapy drugs and those in trial. It’s impossible for clinicians to stay up to date given the boom in immunotherapy drugs, and they should use technology embedded in their EHR systems to help them. The applications should flag new clinical trials and potentially eligible patients and feed that information at the point of care to oncologists.

    3. Proactively communicate about the costs of immunotherapy drugs
    Cancer immunotherapy drugs are quite expensive with many of them costing more than $10,000 per month. With patients staying on the drugs for a year or more, the bill adds up quickly. Using FDA-approved immunotherapy drugs means the patient or the patient’s health plan is financially responsible for that bill. That cost should be part of the initial conversation with the patient. It’s rare for a patient or a patient’s family to pass on a chance for remission because of the price. But, they should be aware of the cost and be prepared to make whatever financial arrangements are necessary. That’s also important for the practice to avoid interrupting a drug treatment plan or incurring bad debt.

    4. Implement appropriate billing operations for reimbursement
    If a practice is administering an immunotherapy drug as part of a clinical trial, most health plans consider the drug an experimental therapy and won’t cover any or all of the cost. Practices enrolling patients in immunotherapy clinical trials need to have more sophisticated billing operations than community oncology practices that don’t participate in trials. A practice’s billing office should have the expertise and technical infrastructure to know who to bill for what part of the clinical trial for each enrolled patient. Some services can be billed and reimbursed as research by the drug company sponsor of a clinical trial. Some services like those that treat side effects can be billed to and reimbursed by a patient’s health plan. Sending the appropriate charges to the appropriate payer or sponsor takes commitment and is important to the financial health of the practice.

    5. Market practice’s clinical trials to referring physicians and academic medical centers
    Community-based oncology practices compete with academic medical centers (AMC) for patients. One way oncology practices can compete is by offering patients access to the latest immunotherapy clinical trials. They should make their status as a research practice known to local referring primary-care physicians. And odd as it may seem, they should make their status as a research practice known to their local AMCs, too. AMCs have many more regulatory and bureaucratic hoops to jump through before they can start a clinical trial whether it’s for a new immunotherapy drug or another new treatment. Community-based oncology practices are more nimble and often can open a clinical trial three or four months ahead of their local AMCs. It’s not uncommon for an AMC-based oncology practice to refer a patient who can’t wait for treatment to a local oncology practice. Effective marketing can build those competitive yet collaborative relationships for small practices involved in immunotherapy clinical trials.

    New immunotherapy drugs to fight cancer will have their maximum impact in the community where most of the applicable cancer diagnoses are taking place. It makes clinical and business sense to have community-based oncology practices serve as the clinical trial sites for these new promising drugs. With the right approach, practices can drive the maximum value for their patients and businesses.  

    Related: Learn more about Studiomaca’s  for community oncology practices.
    Michael Seiden

    About the author

    Michael V. Seiden, M.D., Ph.D., is chief medical officer for Studiomaca Specialty Health and The US Oncology Network. He is responsible for leading the development of a clinical care delivery system that integrates community physician care with the clinical, operational and technological expertise of Studiomaca Specialty. Dr. Seiden received his bachelor's degree from Oberlin College and his medical and Ph.D. degrees from Washington University. He completed his residency at Massachusetts General Hospital, his fellowships in medical oncology and bone marrow transplant at Dana Farber Cancer Institute, and his post-doctoral fellowship at Brigham and Women's Hospital, Department of Pathology.