Clinical Trials Advisor

Drugmakers should consider including more than 100 geriatric patients in Phase II and III databases for new drugs to account for the increasing prevalence and complexity of the elderly patient population, according to a final International Conference on Harmonisation (ICH) guidance adopted by the FDA.

Sponsors would submit one clinical trial application in the EU via a single portal, under a streamlined assessment process advocated by the European Commission (EC).

The FDA should turn away device applications that don’t include sufficient clinical trial data on women, in order to encourage devicemakers to study possible gender differences in their products, a recent Journal of the American Medical Association (JAMA) article maintains.

Studies of approved drugs that involve a route of administration or dosage level that significantly increases the risks or lowers the acceptability of risks associated with the drug are not exempt from clinical trial regulations and must be conducted under an investigational new drug (IND) application, an FDA warning letter reminds researchers.

Drug sponsors who outsource development work to Indian research organizations should not expect original drug discoveries, according to a new study published in the February 2012 issue of Current Science.

Sponsors need to make sure they are conducting clinical trials for the right length of time to support claims of safety and efficacy in the target population — a point driven home in a recent FDA advisory panel debate over Chelsea Therapeutics’ hypotension drug Northera.

The FDA has set a target and maximum “bead size” for drug products that are administered by means of sprinkling onto food, according to a final guidance.

The Global Harmonization Task Force’s (GHTF) Study Group 5 has release a proposed guidance on clinical performance studies for in vitro diagnostic (IVD) devices.

In a regulatory rejection decried as a potential industry game-changer, Columbia Laboratories and Watson Pharmaceuticals have received an FDA complete response letter for their progesterone vaginal gel.

Drugmakers shooting for agency approval of complicated urinary tract infection (cUTI) antibiotics should design trials that assess both the resolution of clinical symptoms and microbiological success at a fixed point in time as the primary efficacy endpoint, according to an FDA draft guidance.

It will likely be four to five years before drug sponsors are forced to submit their investigational, new drug and biologic license applications via the electronic clinical trial document (eCTD) format.

An FDA advisory panel has unanimously recommended lifting a clinical hold on anti-nerve growth factor (anti-NGF) drugs, but one panelist says three sponsors of stalled trials should start over because of inadequate data on the drugs’ risks.

Relevant endpoints for clinical trials of drugs to treat pulmonary arterial hypertension (PAH) in children are exercise, time to clinical worsening and hemodynamic parameters, according to a European Medicines Agency (EMA) final guideline.

The FDA is warning drugmakers to avoid using two types of phthalates as excipients because of safety concerns, according to a new draft guidance.