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Designing protocols to maintain a trial's validity while enabling seriously ill and informed participants to receive both SOC and investigational products will help to improve patient participation in oncology clinical trials.
Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.
Only 3% to 5% of cancer patients participate in clinical trials. Although oncology projects account for almost 31% of global projects, it remains the most difficult therapeutic area in which to conduct clinical trials. Why, and what can be done to improve patient recruitment?
In this Peer Reviewed article "Patient-First Approach to Improve Oncology Trials" that appeared in Applied Clinical Trials in March, 2013, Linda Strause, PhD, proposes that the industry must learn to put the patient at the center of the clinical trial enterprise by viewing the process through the eyes of the patient.
Strause speaks from both professional and also personal experience. As the Executive Director and Head, Clinical Operations, Vical Inc. Research Scientist & Founder, Institute of Palliative Medicine & San Diego Hospice IRB, Strause was also primary caregiver to her husband from the time he was diagnosed with glioblastoma multiforme (GBM) to his death. GBM is an extremely aggressive, highly vascularized, and incurable brain cancer. What Strause discovered on the medical journey with her husband was that hope remains a constant, but hope changes form. "When our neurosurgeon said, "someone is on the right side of the curve," it made perfect sense to me as a clinical research professional. In the beginning we hoped for a cure. With time and disease progression hope changed. A balance must be found between the hope that standard of care (SOC) will work, the hope that the investigational agent in a randomized clinical trial will work, and the hope that there will be dignity in death."
Hope however can be a detriment to participating in a trial. An effort needs to be made “to design protocols that maintain the trial's validity while enabling seriously ill participants to receive both SOC and investigational products that will help to improve patient participation in clinical trials," says Strause. "There exists an obvious paradox in clinical trial participation especially among cancer patients and those facing life-threatening diseases. Although less than 5% of cancer patients enter clinical trials, 42% of those patients surveyed said that they would agree to participate in a clinical trial and 48% of those surveyed were simply uncertain.
Uncertainty stemmed from mixed feelings about new treatments, unknown side effects, randomization, and the perception that clinical trials were frightening. This suggests to Strause that it is time for the clinical research enterprise to review and revise both how clinical trials are described to potential subjects and the ways in which patients with cancer are invited to participate in clinical trials. Understanding the concept of hope and managing that hope through the duration of treatment, from diagnosis to death, may improve participation in clinical trials.
Patient participation may also be improved by providing patients with trial information soon after diagnosis so that they can make decisions about their care that will not preclude trial participation in the future. Such changes will help ensure autonomous decision-making and improve participation in clinical trials. For Strause's husband, when the appearance of a new, small, easily accessible lesion outside the original tumor bed was found the best approach determined was to forgo a biopsy and simply treat with a round of "targeted" radiation. That single decision, an additional round of radiation, resulted in his being excluded from possible participation in a Phase II trial at a later date.
"We have to somehow balance the needs of the patient and the needs of the companies that are trying to introduce new therapies to prolong the life of the patients while maintaining quality of life. In the end researchers need to take a moment and put themselves in the position of the patient and the family. They need to understand the elements of time and hope because if they do, then they will learn to create protocols that better meet the needs of these patients, their families, and their physicians."