But the logistics are extremely tricky, he says, and a trial design has not been finalized.
Pharma teams think they are better at clinical trial design than they actually are.
FORBES: Are We The Problem? The Role Of Poor Decision-Making In Stifling Drug Development
Despite their size and experience, big pharma are not that great at clinical trial design.
FORBES: Are We The Problem? The Role Of Poor Decision-Making In Stifling Drug Development
To AstraZeneca scientists, ImClone's problems seemed simply a question of poor trial design.
Other experts in the field contacted by CardioBrief agreed that the challenges of trial design in this situation are quite formidable.
FORBES: Two Medical Societies Break New Ground To Test Medical Device
These folks are grilled about the data by upper management and all aspects of the program (trial design, data analysis, adverse events, etc.) are reviewed.
Supplies could become available to public health authorities in four to six months, and the FDA is reviewing the final clinical trial design, she said.
Despite some limitations of trial design, including the open label nature of the study, RECORD remains the only randomized trial of cardiovascular outcomes for Avandia at this time.
FORBES: Glaxo Alleges Errors In Nissen's Critique Of FDA's Handling Of Avandia
Obviously, an unblinded trial design (also known as an open-label trial) represents a particularly high-risk approach when the outcome involves a subjective assessment by either the patient or the physician.
Some movement in the U.S. toward consideration of better trial design and analysis is has been afoot, but not a mechanism for offering independent analysis for inclusion in published reports.
Both studies also present challenging problems of trial design.
FORBES: Two Medical Societies Break New Ground To Test Medical Device
Mack concedes that the trial design is not idea.
FORBES: Two Medical Societies Break New Ground To Test Medical Device
Before making this considerable investment, you want to be certain that the trial design is state-of-the art and that the physicians working with your drug are among the best in the world.
FORBES: Do the Interactions of Pharma With Medical Experts Compromise Health Guidelines?
Genta's original trial design included 270 patients--a size Warrell said they thought was OK because Schering-Plough (nyse: SGP - news - people ) had done a cancer trial that small.
As part of the proposed agreement with the family foundations, Nationwide Children's researchers say they are committed to sharing data with other qualified scientists so they can use if for their own trial design.
What we need is a construct with teeth, an established network of industry-independent researchers (not contractors) equipped to evaluate trial design, statistical power, data analysis, and interpretation, not as regulators but as contributors to final research publications.
The results will need to confirmed in a much bigger clinical trial, the design of which Acorda will need to discuss with the Food and Drug Administration.
FORBES: Drug That Helps Multiple Sclerosis Patients Walk May Also Aid Stroke Victims
"This is the first gene-targeted medicine in cardiovascular disease, " says Cleveland Clinic's Topol, who is helping design the trial.
One issue the FDA could be looking at is the highly unusual design of the trial.
Project ALS is now negotiating with government regulators and undisclosed biotech firms to design a human trial that could begin next year.
Although it seemed to outperform warfarin, the design of the trial (doctors and patients knew who was on warfarin and who was getting Pradaxa) weakens that conclusion, and the FDA did not allow a superiority claim.
The results in that small group could allow Celldex to design a future trial that could, on its own, lead to accelerated approval with the Food and Drug Administration for the drug, known as CDX-011 or glembatumumab vedotin.
FORBES: Celldex Therapeutics Breast Cancer Drug Shows Strong Results In Some Patients
The decision was unusual because instead of waiting for data, Merck decided, based on the study's design, that the trial was unlikely to provide a clear answer.
Normally it takes nine months to design a late-stage drug trial.
In order to design and run a successful clinical trial, it is crucial for the actual investigators to collect the data themselves and not rely on information gathered by other groups.
If both patients and health care providers are blinded, the trial is said to have a double-blinded design.
For the best outcome and restoration of trust, this completely independent group of researchers would analyze data (and preferably design) from an industry-linked clinical trial.
In the book, an uncompromising architect browbeats and blusters his way to an unlikely acquittal when put on trial for blowing up a building that compromised his original design.
The trial is significant because it tests the ability of U.S. patent and design laws to keep pace with the fast-changing technology industry and to ultimately benefit consumers.
Charles Verhoeven, the Quinn Emanuel partner representing Samsung in this part of the trial, took the witnesses on an increasingly uncomfortable tour of the fine points of phone design, pointing out a series of small but noticeable differences between iPhones and Samsung designs.
FORBES: Memo to Apple's Experts: Never Cite 'Peanut Butter' In Testimony
应用推荐