May 26, 2019clinops

High Throughput Screening

Kiosks For Urban Recruitment

July 23, 2010

The recruitment of minority patients is hard under any circumstances. But finding research subjects for conditions with a social stigma is especially difficult. Barbara Gladson is director of the biopharma educational initiative at the University of Medicine and Dentistry of New Jersey (UMDNJ). She gave a fascinating presentation on her work at the 2010 annual Drug Information Association (DIA) meeting in Washington, D.C. Gladson is assisting on hepatitis and liver-related trials in the Newark, New Jersey facility. Through the UMDNJ foundation, she's also seeking grants from federal and industry sources for other conditions, including diabetes and hypertension. In cancer trials at UMDNJ during 2007, Gladson related, twenty African-American patients out of 396 with the disease were enrolled, a 5.1 percent rate. Among Latinos, 12 patients enrolled out of 260 with cancer, a rate of 4.6 percent. That was a wake up call. “It should have been much more ethnically diverse,” Gladson…more...

Medidata Buys Fast Track

Protocol Optimization and EDC

April 30, 2008

Want science with that? That question hangs over the recent acquisition of 35-employee Fast Track Systems by Medidata Solutions, a leading electronic data capture (EDC) vendor. The deal (but no price)…more...

Webinar: Tessella, United Biosource

Adaptive Designs: The Regulatory Issues

February 15, 2008

For the all the excitement and anticipation around adaptive designs for clinical trials, there’s always been one pesky fly in the ointment. Do regulators actually bless adaptive approaches when sponsors propose…more...

A Tale Of Two CROs

Pfizer Tackles Clinical Efficiency

November 27, 2007

Our notebook still has a few gems from IIR’s Clinical Technology (“CTECH”) conference, held last month in Philadelphia, which was where we heard Jane Clarke from Wyeth speak. One highlight is…more...

The Case For Outreach

Stopping Drug Safety Spin Cycle

October 12, 2007

A few years ago, thinking the way all journalists think, we had an epiphany. The reportorial brain is the one we’re happily stuck with. But it often adopts a harshly negative, critical outlook that transcends age, geography and political affiliation. We resolved to outgrow that outlook. Then, as luck would have it, we met a few journalists…more...

A Chance To Give Back

Toward A Global Safety Network

September 10, 2007

There is an article in the British Medical Journal related to international aspects of drug safety in the developing world. “Pharmacovigilance in the Developing World,” written by researchers in England and Ghana (Munir Pirmohamed, Kwame Atuah, Alex Dodoo and Peter Winstanley), points out the inadequacies of the networks for drug safety in much of the impoverished world.…more...

Adaptive Logistics

Linking Clinical Trial, Supply Simulation

August 06, 2007

The math of adaptive trials is hairy. But the appeal is simple. Adaptive trials can reveal the optimal dose in a single trial—not six. They can identify dud drugs early. The approach can require significantly smaller sample sizes and save big companies billions of dollars. There’s just one mathematical fly in the clinical ointment. Adaptive trials will,…more...

Phase Forward, OmniComm, Target Health

Wednesday News Briefs

July 25, 2007

Clinical technology suite Phase Forward reported another apparently effortless set of strong financial results. Revenues for the second quarter of 2007 were $31.5 million, a 28 percent increase from $24.7 million in the second quarter of 2006. Within total revenues, electronic data capture license, application hosting and other related revenues were $22.8 million, an increase of 39…more...

The ClinPage Checklist

22 Questions For Adaptive Trials

As life science organizations consider adaptive clinical trial designs, the process, technology and operational aspects are complex. What to consider.

Small, Flexible, Nimble

Prometrika Growth Strategy

Prometrika, a CRO, is adding a clinical-operations arm with the help of a veteran from Nucryst Pharmaceuticals.

Linking Tools for Supply, Randomization

An Adaptive Partnership

Cytel and Tourtellotte consulting have integrated two important applications.

New Tools, More Trials?

Radical Drug Safety Shift

Proposed legislation would profoundly alter the U.S. drug safety landscape.

'Sentinel,' Other Tools Planned

FDA Outlines Major Safety Overhaul

The announcement by the FDA is an ambitious, major effort to reassure the public without explicitly committing the agency to yet another layer of regulation or any specific, lasting changes to how drug safety is reviewed after drugs are brought to market.

Rethinking Everything

Drug Safety Landscape Shifts

The comments from Relsys were made before the recent FDA announcement about drug safety.

Funds for IT, post-marketing, safety

FDA: Raise PDUFA Fees 29 Percent

The agency says $29 million of $87 million in proposed new spending would go toward 80 additional employees to monitor drug safety in the post-marketing arena.

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