Hemispherx forms data-monitoring team

A three-member independent data-monitoring committee will now oversee drug development, provide interim analyses of outcomes data, and ensure subject safety for Hemispherx Biopharma. The committee also will play a role in adaptive trials, overseeing such trial design modifications as eliminating a treatment arm or modifying sample size to increase the statistical probability of success. The committee formation follows last year's no vote by the FDA on Ampligen, an experimental treatment for chronic fatigue syndrome. Release | Article