Clinical investigation forms the backbone and the history of medical oncology. Cancer clinical trials provide the evidence we need to demonstrate safety and efficacy before Food and Drug Administration (FDA) approval and evidence for our clinical treatment guidelines.
However, it seems to be more and more difficult to open trials, enroll patients, and complete all the necessary work involved in cancer clinical trials. Why does it seem so much more involved than even a few years ago?
There are many possible reasons for this, which we must try to streamline and address. Just a partial list of issues includes:
- The federal funding for cancer clinical trials has not kept up with inflation so that the effect has been many fewer trials and a cap on enrollments.
- The regulatory burden of getting a trial open and to continue enrolling has been magnified many-fold over the past few years. Confidentiality agreements, budgeting and contracting, submission to Scientific Review Committees (SRCs) and Institutional Review Boards (IRBs) all seem to take a prolonged period of time. While these steps are important, inefficient and uncoordinated processes can delay opening a trial by months and increase the personnel needed to perform these duties.
- Difficulty with insurance approvals for paying for the routine care costs for patients on clinical trials. Despite the Affordable Care Act, there are still questions, misinformation, and time-consuming processes that result in patients not getting prompt decisions and certain types of policies are left out.
- The clinical trials are often so narrow on the eligibility criteria that the trials are not realistic to evaluate a general patient population with that type of malignancy.
- It takes a lot of time to discuss the clinical trials with patients—in a busy oncology practice, that makes it difficult to take the time needed for this activity.
However, if we want to evaluate new therapies or combinations of treatments for our patients, clinical trials are absolutely necessary. What can we do to improve the situation and get the information we need to help our patients? Here are a few ideas for us to work on together:
- Advocate for continued increases for federal funding of cancer clinical trials and streamlining of the process to improve efficiency
- Work with our ASCO Best Practices in Clinical Research, Exemplary Attributes resources, and Community Research Forum to formulate the “gold standard” for clinical research with respect to many of the clinical trial regulatory aspects that can be standardized and made less complex.
- Review ASCO’s resources about public and private insurance industry coverage of clinical trials to understand what type of coverage is available to patients and where we need to expand coverage options.
- Hopefully, if the process of enrolling a patient on a trial can be streamlined, it will be much more efficient to enroll a patient on a clinical trial and therefore less down-time for the physician and research team.
- We need to modify the eligibility criteria to make them more realistic and similar to the patients who have the illness being evaluated. Our patients we see in clinic are typically older and have more comorbid illnesses and other diverse characteristics than those who can typically enroll in trials today.
- We need to work with the trial sponsors to have treatments and follow-up testing schedules that are similar to what would occur in standard oncology practice.
- Also, we need to look at other possible avenues, such as big data, to find hypothesis generation and perhaps another way of doing large-scale “phase IV” studies. ASCO’s first-ever clinical trial—the Targeted Agent and Profiling Utilization Registry (TAPUR)—will collect streamlined data on new uses of already approved cancer therapies and help generate hypotheses for additional research. CancerLinQ™, ASCO’s big data project, will enable evaluation of outcome and treatment data on thousands of patients in a de-identified database.
If the oncology community can work together to modify many of these issues, we can enhance the future of cancer care and clinical research for our patients.