Indian Regulators Propose New Penalties for Clinical Trials

Clinical investigators in India could face up to five years in jail for studies that violate the country’s clinical trial regulations, under draft legislation released in late December by the Department of Health and Family Welfare. The prospect could further hinder India’s clinical trials industry, one expert says. Read More

Year in Review: Transparency Leads the Clinical Trial Conversation Again

Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials. Read More

EMA Tries to Allay More Concerns About Data Redaction

European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency. Read More