PANDA users may also wish to read more on general data management considerations for adaptive trials.

It is essential to maintain the confidentiality of interim data and results to ensure that those blinded in the trial remain so. A GSD requires comparative interim analyses of unblinded outcome data to assess the emerging treatment effect and for hypothesis testing. Access to unblinded data and knowledge of the interim treatment effect raise serious concerns about potentially introducing bias in the conduct of the trial. This concern can be addressed by assigning the responsibilities for accessing, analysing, and reviewing unblinded interim data to make early trial stopping recommendations to an independent external committee such as a data monitoring or trial adaptation committee ^{1, 2} (see general considerations).

PANDA users may also wish to read more on the discussion around confidentiality during interim analyses and decision-making ^{1, 3, 4, 5, 6}. 

 1. Grant et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess. 2005;9(7):1–238.
2. Bhattacharyya et al. The changing landscape of data monitoring committees—perspectives from regulators, members, and sponsors. Biometrical J. 2019;61(5):1232–41.
3. Fleming et al. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials. 2008;5(2):157–67.
4. Fleming et al. Monitoring clinical trials: Issues and controversies regarding confidentiality. Stat Med. 2002;21(19):2843–51.
5. Sanchez-Kam et al. A practical guide to data monitoring committees in adaptive trials. Ther Innov Regul Sci. 2014;48(3):316–26.
6. Chow et al. On the independence of data monitoring committee in adaptive design clinical trials. J Biopharm Stat. 2012;22(4):853–67.