News

iPhone, 3G show potential for trials

Two new mobile offerings for healthcare show potential for use in clinical trials. One is an iPhone app for phototherapy; the other, remote-monitoring tools available via 3G wireless. AT&T is

FDA drafts expectations for clinical e-data

New guidance from the FDA directs clinical investigators on the capture, use, and archiving of electronic data. The document's aim is to ensure that electronic source data are accurate, attributable

Mannkind on "worst" list for handling of suspect data

Mannkind takes the number seven spot on Jim Edwards's list of the worst drug companies of 2010 based in part on a lawsuit filed by John Arditi, former senior director/GCP/regulatory affairs. Arditi

Meta-analysis challenges statin use in cardio treatment

Meta-analysis of data from 20 cardiovascular-therapy trials, including 4S and Jupiter, reveals that low levels of HDL-cholesterol remain a significant risk even while statin therapies are being used

Poll: Pharma among industries needing more regulation

Pharma ranks among the leading industries that people believe should be more regulated, says a Harris poll. Drugmakers find themselves in the company of oil refiners, health insurance providers,

NCI trial-revamp plans call for IT overhaul

Imagine a comprehensive IT system, collecting standardized clinical trial data including volunteer information and outcomes. It's hardly a revolutionary idea, until you try to apply it across the

Jupiter trial results face calcium/cholesterol conundrum

Jupiter is in the news again. The 18,000-subject trial that made cholesterol-fighter Crestor a hit in late 2008 was so successful that researchers ended it early, allowing subjects receiving the

RedOak readies natural-intelligence software for drug development

Cary, NC upstart RedOak Logic, now at the prototype stage with its natural intelligence software for drug development, seeks $3 million in funding. And CEO Dale Fedewa will be pitching investors this

FDA too rigid in review of drugs for critically ill

Scott Gottlieb has fired a shot across the FDA's statistical-confidence bow. The former FDA Deputy Commissioner, using the Wall Street Journal as his command post, charges the regulator with

EDC can aid in adverse event reporting

The ubiquitous EDC system could be the answer to your SAE reporting prayer. Though a logical place to begin addressing SAE headaches might be by giving sites access to sponsors' safety reporting

Study: Brazil bests India for subject recruitment

Sponsors looking for clinical trial volunteers are better off heading south rather than east. Using systematic review and meta-analysis of data on people's willingness to participate in clinical

GSK opts for BioClinica IVR system across trials

GlaxoSmithKline ($GSK) has selected BioClinica's Trident interactive web response system for use across Phase I through IV trials. The drug giant wants internal staff to be able to set up and manage

Program grows clinical, translational researchers

Wanted: Clinical and translational researchers. The University of Michigan, like the National Institutes of Health, sees a growing need for both. U of M is addressing it through offerings for current

Imaging can lead to investigator ethical dilemma

In clinical trials that include an imaging element, 40 percent of volunteers will have undiagnosed medical conditions that have no bearing on the trial, but that nonetheless reveal themselves in the

PROs join recruitment in social net benefit

Determining the patient-reported outcomes to be measured in a trial and providing data to help speed up studies are two of the drug development areas that can benefit from social media, says a

App connects dictation, transcription via iPhone

Catering to the 81 percent of U.S. doctors expected to be using smartphones by 2012, Nuance Communications has launched a mobile point-of-care dictation app connected to speech-enabled transcription

RE-LY re-analysis reveals AE statistical conundrum

A second look at the data uncovers "scores" of previously unreported and sometimes serious adverse events from the RE-LY trial's published outcomes data. The re-analysis of Boehringer Ingelheim's

E-clinical providers report business uptick

DATATRAK has turned a $420,000 third-quarter income loss last year into a $53,000 third-quarter gain this year. CEO Laurence Birch calls the results a "direct indicator of the company's re-emergence

New programming language will drive DNA

Bioinformatics scientists have built two logic gates for what they hope will become a new programming language for drug design as well as chemical and agricultural product engineering. The

SORIN opts for KIKA EDC in multi-center registries

Cardiovascular specialist SORIN Group, a maker of heart valves, is using the KIKA Veracity electronic data capture platform for clinical asset management in two multi-center real-life registries. The