An oncologist, Ethan Basch, wrote in the March 11 issue of NEJM, that current clinician-based approach to adverse symptom reporting is based on clinicians’ impressions of patients’ symptoms, not on patients’ direct symptom reports. He said that evidence has shown that clinicians responsible for collecting and reporting adverse symptoms in clinical trials systematically downgrade the severity of patients’ symptoms and often miss the side effects, as a result vital information about drug safety is missing .
He argued that doctors, researchers and regulators should pay more attention to patients’ symptom reports while taking a drug because it could help identify symptoms earlier during a course of treatment and reduce preventable harm.
He said that technologies are now available for collecting information directly from patients and patients should be given the tools to self-report adverse symptoms in clinical trials such as online reporting between clinic visits, this can capture a lot of baseline symptoms before the drug is approved including those symptoms that researchers did not anticipate.
He concluded that “patient self-reporting would enhance the capture of subjective elements of safety information and patients are entitled to know the impressions of their peers”, such information would also help clinicians to evaluate the drugs.
Source: "The Missing Voice of Patients in Drug-Safety Reporting". NEJM 362(10):865-869 (full text via Athens)
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