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One in Five Clinical Trials for Adults with Cancer Never Finish – New Study Examines the Reasons

Genitourinary Cancers Symposium
January 28, 2014

In a new analysis of cancer clinical trials for adults registered on Clinicaltrials.gov, researchers found that about 20% never finish for reasons unrelated to how well the treatment or procedure being studied works or the side effects it causes. Poor accrual was the most common reason for a clinical trial to not finish. Accrual is the term commonly used to describe the process of placing patients in the clinical trial. Basically, poor accrual means that not enough people volunteered for the clinical trial.

In this study, researchers reviewed Clinicaltrials.gov to find all phase II and III cancer clinical trials in adults that were registered between 2005 and 2011, identifying 7,776 trials. Those that were marked as “stopped early” in the registry were labeled as failing to complete or never finishing by researchers. Out of these trials, 20% were marked as “stopped early” and out of those, 40% were stopped due to poor accrual. The researchers initially became interested in studying this topic after noting that a series of clinical trials in bladder cancer failed to finish. However, in the current study, they found that genitourinary cancer trials, including bladder cancer trials, were no more likely to end early than trials for other cancer types.

What this means for patients

“When we consider what prevents the translation of clinical trials to new standard treatments for our patients, we generally think of two things – an experimental intervention doesn’t work and/or the side effects are too severe,” said senior author Matthew Galsky, MD, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai and the Director of the Genitourinary Medical Oncology Program at the Tisch Cancer Institute in New York. “However, our findings reveal a third major barrier to progress in cancer care – that a large proportion of initiated clinical trials are not completed at all, failing to contribute to our understanding of how best to care for patients.” 

Cancer clinical trials are how doctors make progress in all aspects of cancer care. The process of learning about cancer is ongoing, but clinical trials remain the most reliable and only accepted scientific method to find out if a new treatment works better than the current standard of care. A low level of participation in clinical trials slows the progress of cancer knowledge. Many people with cancer face uncertainty after diagnosis, even when receiving the standard treatments, but the uncertainty of participating in a clinical trial may be more challenging for some. It’s important to remember that patients choose to participate in clinical trials for many reasons. For some patients, a clinical trial is the best treatment option available. Because standard treatments are not perfect, patients are often willing to face the added uncertainty of a clinical trial in the hope of a better result. Other patients volunteer for clinical trials because they know that these studies are the only way to make progress in treating cancer. Use the questions listed below to help you make treatment decisions and discuss treatment options, including clinical trials, with your doctor.

Questions to Ask Your Doctor

  • What type of cancer do I have?
  • What are my treatment options, including clinical trials?
  • How do the current standard treatments available to me compare to the clinical trials that are available?
  • Would I need to travel for my treatment and care if I participate in a clinical trial?
  • What trial costs are covered by my insurance or the clinical trial sponsor? How does this compare to the standard treatments available?
  • What treatment do you recommend? Why?

For More Information

About Clinical Trials

Understanding Cancer Research Study Design and How to Evaluate Results

Deciding to Participate in a Clinical Trial

Making Decisions About Cancer Treatment

Coping With Uncertainty

© 2005-2014 American Society of Clinical Oncology (ASCO). All rights reserved worldwide.

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