FDA Guidance Offers Recommendations for PRO Assessments in COVID-19 Trials
COVID-19 outpatient treatment and prevention trials can use a new 14-point symptom scale for assessing patient reported outcomes (PRO), according to a direct-to-final guidance the FDA released last week.
In addition to the symptom-reporting scale, FDA recommendations for systematic evaluation of outcomes include conducting assessments daily and at the same time each day; using electronic data collection systems that prompt participants to complete their PROs; using verbal descriptors of symptoms, such as none, mild, moderate, severe; and limiting the number of items to be assessed to avoid subject burden.
When considering endpoints, the FDA says trials should be aware that different COVID-19 symptoms progress and resolve at different rates and that understanding of those timepoints is still evolving. Data from early-phase trials can be used to determine the effect of the investigational drug on the timing of symptoms, the guidance suggests.
The guidance also stresses the need to minimize missing data and offers such recommendations as providing reminders to participants, monitoring participants’ PRO completion, following up with those who are not completing their PROs and recording verbal responses of participants who are not able to complete reports. Informed consent documents should educate trial participants about the importance of providing follow-up data even if they leave the trial.
The guidance does not apply to trials of drugs to treat postinfectious conditions or development programs for preventive vaccines.
While the guidance is intended to remain in effect only for the duration of the current public health crisis, the FDA says it will revise and replace the document within 60 days of the end of the crisis based on public comments received and the agency’s experience in implementing the guidance.
To read the final guidance, click here: https://bit.ly/3ktQFhr.