Clinical Trials Advisor

A new Democratic bill that would require more sponsors to publicly register and report results of clinical trials draws attention to NIH’s failure to release proposed rules on the U.S. trials database following the site’s expansion five years ago under the FDA Amendments Act (FDAAA).

Drugmakers can now access final versions of documents related to the FDA’s major update of the electronic common technical document (eCTD), but industry shouldn’t expect to make regulatory submissions using the new electronic format for at least a year.

For a better shot at recruiting hard-to-reach patients, don’t assume that potential trial participants understand what a clinical study entails.

Sponsors conducting trials of orphan products could get some financial support from the government, thanks to an announced $14.1 million in fiscal 2014 federal grants.

To meet the dual challenges of drug discovery — developing new compounds faster and at less cost, drugmakers should consider forming more integrated partnerships where company staff and academic scientists work side-by-side, one expert suggests.

Pfizer, Johnson & Johnson (J&J) and Elan’s termination of their late-stage program for investigational Alzheimer’s drug bapineuzumab following the second failed study may not negatively impact the companies but could foreshadow a bleak outlook for the future of Alzheimer’s drug development, analysts say.

An investigator has been warned for failing to comply with state laws, the study protocol and IRB requirements during a clinical trial of the first FDA-approved home HIV test, OraQuick.

Bristol-Myers Squibb (BMS) is suspending a Phase II trial of a promising new hepatitis C (HCV) drug candidate that would be part of a new generation of oral combination therapies due to safety concerns.

Strong Phase III or even Phase II data may enable drugmakers to sell certain medicines for unmet needs in the UK before they are approved, thanks to a developing early access program.

The FDA’s recent complete response letter (CRL) on Salix’s sNDA for opioid-induced constipation (OIC) drug Relistor most likely cites safety concerns and signals increased scrutiny for all makers of these drugs, analysts say.

A newly released draft guideline on clinical trial death and injury compensation in India has clinical researchers concerned about how the basis for claims will be decided and payments formulated.