The CenterWatch Monthly, July 2012

Sunday, July 1, 2012 07:30 AM

Patient-driven drug development goes prime time

A new patient-centered drug develop­ment model has emerged, as patients have become more sophisticated, both from a scientific perspective and a business stand­point, about how they can direct clinical re­search and accelerate efforts to create new treatments for their diseases. Some companies have begun to engage patients in protocol devel­opment, while others are exploring direct-to-patient strategies that give patients the responsibility of data collection in clinical studies. As research becomes more patient-centered, sponsors also have focused efforts on ensuring that patient needs and concerns are incorporated into clinical study designs. In addition, regulatory agencies also have elevated the role of patients in setting re­search priorities…

 

Is more investigator training on the horizon?

The pendulum on investigator training is swinging back and clinical investi­gators should take heed. A growing number of regulators, policymakers and the general public are demanding more from the physicians and professionals who oversee the conduct of clinical trials. “The greatest assumption we have made in clinical research is that clinicians should be allowed to do clinical research without proper training. Physicians need to demon­strate that they understand the responsibili­ties and that they can master those respon­sibilities,” said Dr. Greg Koski, president and co-founder of the Alliance for Clinical Research Excel­lence and Safety (ACRES). These shortcomings reveal…

 

Eye on Alexion

Alexion describes itself as “a global biopharmaceutical company that combines groundbreaking science with a steadfast commitment to meeting the needs of patients living with severe, life-threatening and often ultra-rare diseases.” Its success in marketed drugs, as well as its pipeline of future drug candidates, hinges to a great extent on the therapeutic potential of inhibiting terminal complement. This group of proteins is essential in the body’s immune response, but when activated inap­propriately…

 

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WIRB-Copernicus Group acquires New England IRB

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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