Trial Design

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Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. Read More

Investigators conducting clinical trials in India could for the first time face up to five years in jail for trial violations if lawmakers approve a proposed bill, a possibility that could further hinder the country’s clinical trials industry, one expert says. Read More

China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More

Novartis’ cancer drug Afinitor failed to significantly increase survival rates for patients with a rare type of advanced breast cancer, casting further doubt on the drugmaker’s efforts to expand uses of the blockbuster therapy. Read More

The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More

New FDA requirements regarding emergency research on incapacitated patients stress that sponsors must attempt to get permission from the patient’s family to continue a trial that was started without consent and allow patients to opt out once they are conscious. Read More

Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says. Read More

Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies. Read More

Amgen pulled the plug on its experimental stomach cancer drug rilotumumab after data from two late-stage clinical trials raised serious safety concerns, marking the company’s second failed cancer drug this month. Read More

Merck has gained exclusive licensing rights to an experimental Ebola vaccine that is still undergoing clinical trials under a deal with NewLink Genetics. Read More

Future FDA guidances on developing drugs for specific indications will include key milestones to help manufacturers set up their product development programs and guide potential talks with the review division. Read More

Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance. Read More