How to Speed Up the FDA Drug Approval System: Interview with: Bruce Thompson, President, Clinical Trials & Surveys Corp

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How to Speed Up the FDA Drug Approval System: Interview with: Bruce Thompson, President, Clinical Trials & Surveys Corp, a solution provider at the marcus evans Evolution Summit 2013, on how clinical trial data need to be managed for a speedy FDA approval.

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How to Speed Up the FDA Drug Approval System: Interview with: Bruce Thompson, President, Clinical Trials & Surveys Corp

  1. 1. How to Speed Up the FDA Drug Approval System those particular domains from which the FDA drives all of its analyses. The goal is to have as few iterations back and forth with reviewers as possible. What level of insight does Clinical Trials & Surveys Corp have into what information the FDA requires? It is not We have a good track record working with the FDA and were responsible for converting 51 HIV clinical trial submissions (with multiple data sets) so muchInterview with: Bruce Thompson, into a common set that FDA staff couldPresident, Clinical Trials & Surveys review on a meta-analysis basis.Corp The FDA has a 45-day period to respondChief Medical Officers (CMOs) must lookat how the data of their clinical trialsare going to be reviewed by the US to the sponsor whether it will accept the data as they were submitted. C-TASC staff actually wrote software for the FDA that helps FDA staff make that the trialFood and Drug Administration (FDA)and ensure that the data they submitcan be analyzed quickly and efficiently, assessment within the stated time period. but the way thatsays Bruce Thompson, President, This means we know exactly what theClinical Trials & Surveys Corp. FDA reviewers are looking for and what will speed things up. This innovationFrom a clinical research company and insight goes beyond simple data areattending the marcus evans Evolution checking of the data set for outliers orSummit 2013, in Palm Beach, Florida, consistency checks, which are mainly anMay 8-10, as a solution provider, Information Technology function, butThompson shares his insights into what ac t u a l ly b r i ng s i n a s ta t i s t i c alFDA reviewers look for and how thedata submission process can improve. component. This increases the likelihood analyses will be approved on a first-pass basis. organized that slowsHow can CMOs speed up the FDAapproval process? What causes the most delays?The FDA is moving its submission We have found that what delays FDA down FDAprocess towards the Study Data reviews the most are the ways adverseTabulation Model (SDTM), so CMOs events are reported and grouped withneed to be on board with the new MedDRA codes. Those data must bemethodologies in place for submitting organized from the start to the end of approvaltheir data. the adverse event, with all the history involved during the event, so thatThe information needs to be collected statistical analysis can be done quickly.and organized in a specific way. Thereare 18 domains of data that the FDA When an adverse event is detected,reviews, so the forms and data CMOs have to look at the specificmanagement systems have to be clearly elements of what happened during themapped into the SDTM format. CMOs treatment. That is difficult to do wellcan utilise software packages that can within the SDTM framework, and itmap out their relational database into seems to hold reviews up quite a bit.
  2. 2. The Pharma Network – marcus About the Evolution Summit 2013 evans Summits group delivers peer-to-peer information on This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May strategic matters, professional 8-10, 2013. Offering much more than any conference, exhibition or trade show, this trends and breakthrough exclusive meeting will bring together esteemed industry thought leaders and innovations. solution providers to a highly focused and interactive networking event. The Summit includes presentations on improving trial performance, establishing strategic alliances, site selection and e-recruitment. www.evolutionsummit.com Please note that the Summit is a closed business event and the Contact number of participants strictly limited. Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.comAbout Clinical Trials & Surveys CorpC-TASC, a CRO with extensive Statistical and IT services, has been coordinating studies, (especially pulmonary, cardiovascular, andHIV studies) for nearly 25 years. C-TASC staff have also used their expertise to assist the FDA with the review, mapping andanalysis of new and legacy NDA datasets. Their award-winning rapid review system for NDA submissions is such an example.www.c-tasc.comAbout marcus evans Summitsmarcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discussstrategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity toindividually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings.For more information, please visit: www.marcusevans.comUpcoming EventsDiscovery Summit (Europe) - www.discovery-summit.comEvolution Summit (Europe) - www.evolution-summit.comTo view the web version of this interview, please click here: www.evolutionsummit.com/BruceThompson

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