FDA Offers Guidance on Integrated Analyses in NDA, BLA Submissions

Drugmakers submitting NDAs and BLAs should prepare a comprehensive analysis of all clinical trial data that describes the therapy’s effectiveness, strengths and weaknesses and highlights missing information, such as pharmacokinetic or pharmacodynamic studies, the FDA says.

This integrated summary of effectiveness, or ISE, should include a tabular listing of all studies relevant to effectiveness, followed by concise descriptions of all completed well-controlled studies, whether or not they support effectiveness, according to final guidance released last week.

The guidance — which finalizes a 2008 draft — includes new information on when sponsors should pool and analyze data from different studies.

Such analyses should focus on subject-level data or common outcomes and be used to assess the effects of factors including age, gender and ethnicity, and the presence of specific concomitant illnesses when individual studies don’t have enough subjects to support meaningful conclusions, the agency says.

The FDA cautions against pooling data when studies differ in important demographic or disease characteristics, treatment practices and study design features, since those differences may affect the validity and interpretability of any analyses.

Read Integrated Summary of Effectiveness here: www.fdanews.com/10-15-FDA-ISE.pdf. — Jonathon Shacat