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Publicity, regulation tightening reins on use of KOLs

Doctors used to consider it an honor to be chosen as “key opinion leaders” (KOLs) by life sciences companies. They were able to help develop new treatments. They garnered the prestige of being considered thought leaders in their areas. And they got paid, sometimes quite handsomely. Drug and device makers, in return, received advice that helped them attune products to what patients really needed. And they basked in the prestige of the most respected medical figures. But bad press and congressional investigations into the cozy relationship between doctors and drug sponsor companies have changed the…

Time may be right to makeover the investigator brochure

In drug development, the investigator’s brochure (IB) has long served as the central reference document about an investigational product. It is intended to equip clinical researchers with what they need to make an unbiased risk-benefit assessment of the experimental medicine involving human subjects. But by virtue of its size and complexity, the IB rarely gets a thorough reading, and anecdotal evidence suggests the time and expense invested in its creation reap a relatively modest return. Rethinking the way the IB is developed and utilized may present major opportunities to educate study staff and motivate enrollment, as well as help detect and deter potential…

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