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The Role of Patient-Reported Outcomes in Clinical Trials

April 27, 2022

Between 1999 and 2021, the U.S. conducted more clinical trials than any other developed country, according to the World Health Organization (WHO), which was 157,618 trials. Coming in for a relatively close second was China, having conducted 80,333 studies in the same period. Japan comes in third, conducting 57,754 studies at that same time. Indeed, these numbers are impressive, but what some of these studies have contributed to the world pales by comparison.

What Are Clinical Studies and How Does the World Benefit from Them?

Although the U.S. is currently leading the way, the number of clinical studies conducted globally has increased considerably in the last few years. Many people stand to benefit from that increase, especially those diagnosed with and fighting to beat cancer. While many people are familiar with clinical studies in name, very few know what they’re about or the crucial role they can play in identifying new treatments and even potential cures for disease. 

To broaden our minds regarding both of these things, it helps to look at an article published by clinicaltrials.gov, a part of the U.S. National Library of Medicine and the National Institutes of Health. This article states clinical trials are research studies carried out on volunteer study subjects by investigators to help evaluate a medical, surgical, or behavioral intervention.

What Are Interventions?

In a clinical study, an intervention is a specific variable that investigators evaluate for safety and efficacy. Therefore, an intervention in a clinical study can involve any of the following interventions:

  • New drugs, including targeted and immunotherapies to treat cancer
  • New medical devices
  • Medical procedures

Through clinical studies, new medicines and medical treatments are made possible. These breakthroughs are responsible for immunotherapies that effectively treat certain cancers and cannabidiol-based medications, namely Epidiolex, which was recently approved by the Food and Drug Administration (FDA) to treat severe forms of epilepsy. 

These are only a few examples, but thousands of clinical studies are conducted annually in the U.S., many of which will someday play a pivotal role in bringing about breakthroughs in pharmacotherapies and medical protocols. However, this success level requires favorable patient outcomes, which explains why so much time, effort, and money goes into research and innovation even before a clinical study gets underway.

Oncology Research and Oncology Clinical Trials: How Science is Helping to Combat Cancer

Oncology clinical studies, also known as oncology clinical trials, are vitally important since they enable many to avoid unfavorable outcomes for certain cancers. To put this into perspective, research and innovation coupled with favorable patient outcomes played a part in the FDA approving the following immunotherapy drugs for individuals diagnosed with lung cancer:

  • Tecentriq
  • Libtayo
  • Imfinzi
  • Yervoy
  • Opdytruda

The Challenge of Getting More Americans to Participate in Oncology Clinical Trials

For all the good that clinical studies bring to the medical and scientific communities, not everyone is keen to participate in them. Many say the fear of a possible breach of patient data deters them the most, according to several clinical practices across the U.S., including The ASCO Post and Oncology Practice Management, both of which are clinical practices specializing in oncology research. 

The fear of a possible breach of patient data is an understandable concern, and it’s something that hundreds of clinical practices across the U.S. take seriously. Accordingly, they all exercise considerable due diligence in keeping DOBs, SSNs, and other sensitive patient data away from prying eyes. However, they will share patient-reported outcomes with relevant parties as needed.

How Patient-Reported Outcomes Pave the Way for Better Value-Based Care

To get a sense of how patient-reported outcomes help improve value-based care, it helps to know more about what these two things mean relative to a clinical study. According to Ethan Basch, an esteemed medical oncologist, health services researcher, and Professor of Hematology-Oncology and Health Policy and Management at the University of North Carolina, a patient-reported outcome is a self-report of symptoms, physical functioning, and general feeling by a participant in a clinical study. In short, it’s a way to gauge a study’s effectiveness or ineffective interventions.

When it comes to oncology drugs, researchers will rely on patient-reported outcomes to gauge whether or not a drug is effective. In many cases, the ones that study participants say are effective get sent to the Center for Drug Evaluation and Research (CDER), reviewed further, and sent to the FDA for final approval if all goes well. If approved by the FDA, those same oncology drugs, once only available via a clinical study, can then be distributed to more people. As a byproduct of that, physicians have more ways to treat cancer patients, improving value-based care and overall patient care.

The Bottom Line

Patient-reported outcomes can provide valuable insights concerning more than cancer treatments alone. From diagnostic tests to assessing the quality of medical equipment and everything in between, self-reporting from study participants makes it easier to diagnose and treat people who develop the same or a similar health condition even after a clinical study ends.

About Verdi Oncology Research

Verdi Oncology Research is an advanced clinical research program that allows us to identify and provide the best medical solutions that treat the whole person, not just the disease. We offer access to world-class clinical trials at every treatment phase, allowing us to provide more advanced treatment options that improve patient outcomes.