FDA Proposes Sponsors Collect Fewer Data on Non-serious Adverse Events

Drug sponsors may be able to collect fewer data for non-serious adverse events for late-stage clinical trials and postapproval studies.

A selective approach to collecting safety data during late-stage trials makes sense in some instances when much is already known about a drug’s safety profile, the FDA says in final guidance released Thursday.

For example, if data collected on hundreds of patients reveal a small presence of headaches in early-stage trials, a sponsor would not need to gather similar data in thousands of additional patients in a large Phase 3 trial, as it would require extensive resources while providing minimal value.

The agency acknowledges that the recommendations may not align with regulators’ expectations in other countries and could present challenges for sponsors.

Selective safety data collection may be appropriate when the following conditions are met:

  • The number of patients and their characteristics, the duration of exposure and dose range used in previous studies adequately convey the drug’s safety profile for non-serious adverse events;
  • The occurrence of common, non-serious adverse events has been “generally similar” throughout multiple studies; and
  • It is “reasonable” to determine their occurrence rates will be similar to those of previous investigations.

The guidance also spells out what types of clinical trials might be appropriate for selective data collection:

  • Clinical investigations of new indications of approved drugs;
  • Postapproval clinical studies and trials conducted to fulfill postmarketing requirements;
  • Late-stage premarket and postapproval outcome studies;
  • Premarket clinical investigations for some original applications; and
  • Postapproval clinical trials in a different patient population or with different doses or other conditions of use.

The guidance notes that the amount and types of data appropriate for selective collection will depend on the disease being studied, the patient population, subgroups or subgroups of interest, nonclinical findings, experience with the drug and drug class and study design.

In addition, the agency discusses specific types of data for which sponsors can limit or halt collection. These include non-serious adverse events not associated with dose modification or drug discontinuation, routine laboratory monitoring, information on concomitant medications and patient history and physical exams.

The guidance cautions that there may be instances in which sponsors should collect complete data to better characterize the drug, such as to collect complete safety data in population subsets. Further, certain types of safety data always should be collected — such as all serious adverse events; adverse events that lead to dose modification, drug discontinuation or withdrawal from the trial; data on unscheduled hospital visits and injuries; and data from all Grade 3 and Grade 4 adverse events in oncology trials.

The FDA adds that sponsors considering the collection of selective data should consult with the agency during the end-of-Phase 2 meeting to determine if collecting less data is appropriate. Read the guidance here: www.fdanews.com/02-18-16-SelectiveSafetyDataGuidance.pdf. — Michael Cipriano


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