The reaction of cancer patients who engage in clinical studies has become a concern for healthcare specialists. As such, researchers from Bayer and The University of Texas MD Anderson Cancer Center, have partnered to understand the impact of new oncology therapies.
The new collaborative project aims to have direct contact with clinical trial participants to increase knowledge on the effects of investigational drugs given to oncology patients.
In order to deepen the understanding of the impact that studies have on patients’ disease-related symptoms and help overcome some obstacles in clinical trials, the project will provide in-depth questionnaires to patients. “Fit-for-purpose patient-reported-outcome (PRO) measures are an invaluable resource for helping us to better understand how patients are actually being affected by new therapies,” explained the chair of symptom research at MD Anderson, Charles Cleeland, Ph.D.
“This will be especially important in the developmental pathway of new drugs, given that these PRO measures will enhance information about treatment tolerability and potential symptom-reduction benefit earlier in the drug development process,” Cleeland added. “For patients and their physicians, knowing the probable effects of a treatment can help with decisions among treatment options when therapeutic outcomes are similar but symptomatic effects are not.”
Researchers plan to interview patients about both the symptoms related to their disease and experienced while participating in clinical trials. Later on, the project plans to design short PRO measures that are able to determine not only the symptoms, but also the severity and interference of investigational drugs on patients’ quality of life. The questionnaires will be handed out to patients enrolled in phase II and III clinical development programs for Bayer compounds.
Researchers believe that the results of this collaboration may bring benefits towards the assessment of drugs under investigation in later stages of clinical development and in large pools of patients.
“The ultimate goal is to develop patient-centered measures that will provide new understanding about the patient’s experience with experimental therapies,” stated the vice president for strategic industry ventures at MD Anderson, Ferran Prat, Ph.D., J.D. “This new venture is an exciting model for delivering previously uncaptured information that will directly benefit patients.”
The necessity for more data on cancer symptoms and treatments was recently evaluated as one of the top six high-priority topics in a report from the American Society of Clinical Oncology. The analysis emphasized the lack of comprehensive information and quality-of-care measures able to fulfill the gaps in oncology care, with a necessity to focus more on patients than on health care professionals. Therefore, the researchers believe this project may help patients, physicians, federal drug regulators and insurance companies alike.