TORONTO, ON--(Marketwired - June 21, 2016) - Accurate, complete and compelling clinical trials data is an essential piece in securing US Food and Drug Administration (FDA) approval for a new treatment. Though this data is collected based on a variety of clinical trial-specific outcomes measures -- such as tumor size reduction and progression-free survival -- it might not always be collected from the patient's perspective.
While clinical trials may do a good job of assessing a drug or treatment's efficacy at treating a disease, they often fail to take into account the patients' experience when participating in a clinical trial. Clinical trials most often rely upon observer-reported outcomes whereby a physician, clinician or clinical trials staff member records outcomes-related data based on their interpretation of the treatment's efficacy.
Once a medication is approved for use by the FDA, patient-reported outcomes become an important tool to guide patients and clinicians to make the best treatment decisions possible. In a field like oncology where patients may have a number of treatment options, patient-reported outcomes can help match the patient to the treatment that will be most effective, while minimizing side effects. If two oncology treatments offer equivalent survival benefits, patient-reported outcomes could be used to differentiate between the treatment choices by identifying which treatment had fewer negative effects on patient health.
Relying on traditional observer-reported outcomes alone, physicians only know what results were seen in the trial participants as a group. Individual patient outcomes are consistent with the trend toward precision medicine, to ensure cancer patients are given more personalized treatment.
As well as taking the clinical trial participants' experience into account, patient-reported outcomes have the benefit of supporting certain label claims, making them potentially very valuable to the drug developer. The FDA recommends that sponsors include patient input when designing a patient-reported outcomes measure, to ensure the instrument is developed to produce credible results.
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