Trial Design

EMA Issues Guideline on Covariates in Clinical Trials

Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments. Read More

EMA Releases Guideline on Lupus Trials

For the first time, the European Medicines Agency has produced a guideline on clinical trial design for drugmakers developing targeted products to treat lupus — an effort by the EMA to encourage more companies to target the underserved disease. Read More

EMA Releases Final Guidance on Insulin Biosimilars

Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week. Read More

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