DRUG DEVELOPMENT COMPLEXITIES ARE DRIVING CHANGE The drug development model has not fundamentally changed in more than 50 years. Study complexity is increasing year over year, and traditional approaches for conducting clinical trials are struggling to keep pace with the volume of data while maintaining quality. According to Tufts Center for the Study of Drug Development, as more procedures are performed and more data are collected, study timelines grow longer, patient recruitment and retention grow more difficult and drug development costs increase. INCREASED COMPLEXITY Study complexity and data volume continue to increase rapidly, while the need to maintain high quality standards remains. Shifting from observational to controlled post-approval studies Generating more data from complex chronic illness studies Increasing interest in drug safety data and comparative effectiveness “ T H E A M O U N T O F D ATA B E I N G G E N E R AT E D THROUGHOUT A CLINICAL TRIAL HAS EXPLODED DUE TO INCREASED PROTOCOL COMPLEXITY AND R E Q U I R E M E N T S T O C O L L E C T A D D I T I O N A L D ATA .” Growing demand for data that differentiates products based on efficacy and/or safety Ke n n e t h Ge t z 169 pages in average CRF 13 endpoints including 1 primary and 5 ‘key’ secondary 167 procedures to support primary and key secondary 35 inclusion and exclusion criteria 4,000+ data points collected, per patient O N E O F T H E M A J O R I S S U E S R E S U LT I N G FROM THE INCREASING COMPLEXITY IS M I S S I N G D ATA 6 9 % OF ALL PROTOCOLS R E Q U I R E AT L E A S T 1 A M E N D M E N T (61 day s adde d pe r ame ndme nt) T H E A V E R A G E C L I N I C A L T R I A L I S D E L AY E D 2 5 % B E Y O N D T H E E X P E C T E D T I M E L I N E INCREASED TIMELINES Nearly 80% of all clinical trials fail to meet milestones due to increased complexity, delaying the delivery of important drugs to the market. $ 6 0 0 K - $ 8 M L O S T E A C H D AY A D R U G I S D E L AY E D F R O M THE MARKET THE COST OF A SINGLE CLINICAL TRIAL CAN EXCEED $100 MILLION $ AVERAGE INDUSTRY PHASE III CLINICAL TRIAL COST EXCEEDS $ 4 1 K P E R PAT I E N T I N I T I AT I N G A S I T E C O S T S $ 2 0 K – $ 3 0 K M A I N TA I N I N G A S I T E C O S T S A P P R O X I M AT E LY $1,500 PER MONTH INCREASED COST (11% of sites in a given trial will not enroll a single patient) Bringing a new drug to market takes 12-15 years and costs up to $1.6 billion. With the exception of post-marketing studies, the cost of each drug development stage increased over 60% between 2008 and 2013. MARKET FORCES DRIVING CHANGES EMPHASIS ON DRUG S A F E T Y D ATA N EW D E M A N D FO R H EA LTH E CON OM ICS A N D OUTCOM E S R ES EA RCH (HE O R) SHIFT TOWARD PERSONALIZED MEDICINE AND ORPHAN DRUG DEVELOPMENT M I S S I N G D ATA P O S E S T H E B I G G E S T H U R D L E F O R T H E F I N A L A N A LY S I S Missing data detrimentally impacts study data integrity and may even compromise the statistical analysis and final study conclusion. The Data Quality Manager (DQM) identifies and resolves the "errors that matter" by determining the root cause and deploying the necessary resources and tools. ENTIF RISKS Y ID “ B I O S TAT I S T I C I A N S C A N W O R K WITH MANY TYPES OF ERRORS, BUT THEY CANNOT DO ANYTHING W I T H M I S S I N G D ATA .” Gare t h Ad am s THE IS • Protocols • Sites • Dynamics SUE FUNCTIONS • Clinical Operations • Project Management • Medical Monitoring • Drug Safety • Data Management • Biostatistics D ATA SOURCES • EDC • eCRF • CTMS • ePRO • eLab • IXRS B Y L E V E R A G I N G T H E P O W E R O F C E N T R A L A N A LY T I C S A N D T H E D Q M , T H E S T U D Y T E A M S F U N C T I O N M O R E E F F I C I E N T LY W I T H L E S S D O W N S T R E A M E R R O R S I M PA C T I N G T H E Q U A L I T Y O F T H E F I N A L D ATA B A S E P R A R E A L-WO R L D SUCCESS STORIES Using a suite of central analytics, PRA identified missing safety data on a large Phase III study. We discovered a number of principal investigators (PIs) who were not following protocol-specific safety reporting guidelines. Furthermore, the issues were compounded by the PIs being unavailable during the CRAs' interim monitoring visits. On one study, a DQM noticed excessive patient drop-out rates. The DQM researched the issue and discovered that the study protocol required too many blood draws. Once the issue was identified, we worked with the sponsor to amend the protocol and the eCRF, ultimately reducing the number of patients lost to follow up. Controlled substance studies have an inherent risk of drawing volunteers with a history of substance abuse solely to obtain controlled substances, especially opioids. In 3 recent opioid studies, the DQM used duplication algorithms to identify a number of subjects with the same date of birth, race, height, and weight. Subsequent analyses identified 2 "multiple enrolled patients." After consulting with the sponsor, these subjects were excluded from the study. Our "drug seeker" detection algorithms are now standard on all controlled substance studies. SOURCES: CenterWatch Cutting Edge Information Life Science Leader PhRMA Tufts Center for the Study of Drug Development © PRA 2014. All rights reserved. p r a h s.co m
© Copyright 2024 ExpyDoc
