Life Science Leader Magazine Supplements

CRO Leadership Awards 2014

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

Issue link: https://lifescienceleadermag.epubxp.com/i/266911

Contents of this Issue

Navigation

Page 10 of 45

LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 9 In the big world of clinical trials, it's the small stuff that counts. © PRA 2014. All Rights Reserved. 3.14 WŚĂƐĞ/ /s &Ƶůů ^ĞƌǀŝĐĞŝŽƉŚĂƌŵĂĐĞƵƟĐĂůƌƵŐĞǀĞůŽƉŵĞŶƚ ŵďĞĚĚĞĚĂŶĚ&Ƶůů^ĞƌǀŝĐĞ^ŽůƵƟŽŶƐ dƌĂŶƐĨŽƌŵŝŶŐůŝŶŝĐĂůdƌŝĂůƐƚŚƌŽƵŐŚ KƵƌWĞŽƉůĞ /ŶŶŽǀĂƟŽŶ dƌĂŶƐƉĂƌĞŶĐLJ >ĞĂƌŶŵŽƌĞ about our ƚĂŝůŽƌĞĚƐŽůƵƟŽŶƐ WZƐĞƌǀĞƐĂƐĂƚƌƵĞĞdžƚĞŶƐŝŽŶŽĨŽƵƌĐůŝĞŶƚƐ tĞƚĂŝůŽƌĞĂĐŚƉĂƌƚŶĞƌƐŚŝƉƚŽLJŽƵƌƐŝnjĞ ĐƵůƚƵƌĂůďĂĐŬŐƌŽƵŶĚ ƉŝƉĞůŝŶĞ ƐĞƌǀŝĐĞ ĂŶĚŽƉĞƌĂƟŽŶĂůƌĞƋƵŝƌĞŵĞŶƚƐ clearlypra.com be true. "A client wanted to conduct a trial with six 'arms,'" she states. "They wanted to compare each 'arm' with everything. It wasn't a large pharma company with deep pockets, but a very small start-up that wanted to get everything done in one trial." According to Anderson, this propensity in smaller companies to try to collect every piece of ancillary informa- tion persists out of the fear that a regula- tory agency might, at some point, ask for it. He doesn't believe this to be adequate justification for overcomplicating a trial and reminds, "If you fail to ask a question, you can always do another clinical trial." In other words, don't fall into the trap of trying to capture everything just to remain bound to the clinical trial time line. To ask better questions requires greater delibera- tion in the clinical trial design process at the beginning of the study design. This requires slowing down the overall process if you really want to speed up completing a well-designed study. SPEED UP BY SLOWING DOWN A recent study of 343 businesses, published by the Harvard Business Review in con- junction with the Economist Intelligence Unit, revealed that businesses embracing business-accelerating initiatives in order to gain an edge ended up with lower sales and operating profits than those pausing at key moments. Over a three-year period, firms that slowed down improved top-line performance — averaging 40 percent higher sales and 52 percent higher operating prof- its. Fiore advocates applying these same philosophies in the clinical trial space. "I like the point about asking questions about what is going to be done with each data element," he says. "By virtue of that conver- sation, it slows down the up-front design process." Fiore believes this is just the start- ing point and supports applying QbD prin- ciples to the clinical trial design process. A recent article by Frederic Sax, M.D., Quintiles' global head for integrated drug development, provides a succinct framework for applying quality by design (QbD) principles to clinical trials — Plan- Do-Check-Act. The "Plan" phase requires what he calls design diligence. Heyrman believes it is this planning phase that serves as one of the biggest roadblocks 0 3 1 4 _ R o u n d t a b l e _ I m p r o v e . i n d d 4 0314_Roundtable_Improve.indd 4 2 / 1 9 / 2 0 1 4 1 : 4 1 : 2 6 P M 2/19/2014 1:41:26 PM

Articles in this issue

Links on this page

Archives of this issue

view archives of Life Science Leader Magazine Supplements - CRO Leadership Awards 2014