Why Is Getting a Patient on a Clinical Trial So Difficult?

Why Is Getting a Patient on a Clinical Trial So Difficult?

Julie Vose, MD, MBA, FASCO

Aug 04, 2015

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.

Share this Commentary with your Twitter followers


The ideas and opinions expressed on the ASCO Connection Blogs do not necessarily reflect those of ASCO. None of the information posted on ASCOconnection.org is intended as medical, legal, or business advice, or advice about reimbursement for health care services. The mention of any product, service, company, therapy or physician practice on ASCOconnection.org does not constitute an endorsement of any kind by ASCO. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the material contained in, posted on, or linked to this site, or any errors or omissions.


Mehmet Sitki Copur, MD, FACP

Aug, 08 2015 7:54 PM

Thank you Dr. Vose addressing such a vital topic for the future of oncology.  I agree, support, and applaud all of the points  you have made. Recent great advances in basic science and drug development are pushing clinical trial designs to evolve too.  I can not help feeling  at times that our  kind of now "old-fashioned" prospective, randomized clinical trial design is falling behind the pace of these advances. As we all have witnessed that by the time a good trial is completed the results of it may become irrelevant, yet this kind of clinical cancer research comes at high costs and large chunks of (scarce) physicians’ and other researchers’ time.The basket trial design now is one way in which developing science is being integrated into clinical research in oncology. As with any other approach to translational medicine, the success of this strategy will depend on the rigor of both preclinical development and preactivation trial design, but most importantly largely, as you have addressed, on the possibility of enrolling patients onto clinical trials despite all the existing hurdles. The National Cancer Institute (NCI)  launched NCI-MATCH (Molecular Analysis for Therapy Choice) trial to screen an estimated 3,000 patients and enroll at least 1,000 patients for a targeted drug combination, independent of tumor histology, The NCI-MPACT (Molecular Profiling-Based Assignment of Cancer Therapy) trial is randomly assigning patients with a mutation in a specific genetic pathway to either a targeted therapy for that pathway or a treatment not known to be pathway specific, and as you quote ASCO`s first ever clinical trial TAPUR is looking into new uses of approved therapies. All of these initiatives will pay off IF a very robust national clinical trial enrollment can be secured. The vital significance of clinical trial enrollment should be  incorporated into the curriculum of medical schools, residency and fellowship trainings, and to maintenance of certification requirements to enable a culture change in the minds of providers first,  while we are currently working on the insurers, patients, and regulatory bodies which by no means any lesser challenge. Anytime a patient is enrolled onto a clinical trial it is a miracle happening,  and a sign of that  God has not given up on human beings  curing cancer.

Julie Vose, MD, MBA, FASCO

Aug, 09 2015 11:35 PM

Thanks Dr. Copur for bringing up these important additional points.  Emphasizing the role of clinical research much earlier in the education of physicians is vital to set an excellent foundation and expectation that this should be the norm and not the exception that patients be considered for clinical trials.  Modifying the culture of the physicians, the healthcare system, as well as the regulatory bodies and pharmaceutical industry are key to improving therapies for our patients.

Back to Top