Incorporating Patient-Reported Outcomes in Drug Labels

During this segment of the Oncology Stakeholders Summit, Spring 2015 series, Bruce Feinberg, DO; Scott Gottlieb, MD; and Michael Kolodziej, MD, discuss their concerns and the concerns of manufacturers regarding the inclusion of information on patient-reported outcomes (PROs) in drug labels.

Dr Gottlieb discusses the FDA’s role in allowing the inclusion of PRO data, notes the cumbersome process that manufacturers are faced with when incorporating the data into drug labels, and describes his concerns regarding how PRO data may be interpreted or misinterpreted by patients. For instance, he explains that in the oncology setting, where data regarding a drug’s efficacy are often the focus, if data on PROs are included in a drug label, patients may focus instead on quality-of-life claims. He adds that patients often make trade-offs based on side effect profiles.

Dr Kolodziej remarks that the costs of drugs further complicate the treatment decision-making process, especially in cancer recurrence scenarios. “I would want to know whether [the drug] works and what it is going to cost me,” says Dr Kolodziej, who is hopeful that PROs data will help to better define the true costs of healthcare.

Because patients will use the information found on drug labels when making personalized treatment decisions, Dr Kolodziej emphasizes the importance of considering PRO data as part of shared decision making.