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Automating Phase One Clinical Trials
The document discusses the trend toward automating phase I clinical trials. Historically, phase I trials have been largely paper-based, which has led to challenges around volunteer recruitment, complex workflows, scheduling studies, ensuring sample integrity, and accurately capturing data. However, there is a growing trend toward automating phase I trials using solutions like Oracle's LabPas in order to address these challenges, improve efficiency, and help phase I clinics and sponsors better manage costs, quality, and speed of data delivery. The document outlines key benefits and features of LabPas for automating phase I trials.
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Automating Phase One Clinical Trials
- 1. PREVIOUS NEXT PREVIOUS NEXT PREVIOUSNEXT Automating Phase One Trials November 5, 2012 Param Singh Vice President, Clinical Trial Management Solutions BioPharm Systems, Inc. Ed Dougherty Senior Sales Consultant Oracle Health Sciences GBU 1
- 2. PREVIOUS NEXT PREVIOUS NEXT Welcome& Introductions Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. • CTMS practice director since 2007 – Expertise in managing all phases and styles of clinical trials – Leads the team that implements, supports, and enhances Oracle’s LabPas and Siebel Clinical solutions • Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical – 15+ implementations – Spearheaded the creation of the Siebel Clinical “accelerator” ASCEND 2
- 3. PREVIOUS NEXT PREVIOUS NEXT Welcome& Introductions (cont.) Ed Dougherty Senior Sales Consultant Oracle Health Sciences Global Business Unit • 17+ years of experience in Life Sciences – Primary focus: clinical development – Facilitates client understanding of Oracle Health Sciences applications through presentations, demonstrations, and workshops – Prior to joining Oracle, worked for Medidata, leading implementations of their EDC solution and helping to define their product strategy 3
- 4. PREVIOUS NEXT PREVIOUS NEXT Agenda •Historical approach to managing phase I trials • Challenges of historical approach • Emerging trend toward automation • Overview of LabPas, Oracle’s phase I clinic automation solution • Minimum requirements for phase I solution • Time for questions 4
- 5. PREVIOUS NEXT PREVIOUS NEXT CurrentState of Phase I Since 2008, phase I costs have increased: • 32% for subject recruitment • 68% for each subject per trial • 108% for staffing The biggest challenge, according to sponsors, is finding “trial sites and clinical research organizations that can yield reliable, high quality data.” -- Clinical Trial Costs Are Rising Rapidly Pharmalot, Pharmalive.com, 26 July 2011 5
- 6. PREVIOUS NEXT PREVIOUS NEXT PhaseI Trial Management, Historically Almost entirely paper-based 1. Volunteer recruiters manually verify study eligibility 2. Nurse/Technician records screening and study data by hand on paper 3. Human “checkers” stand behind Nurse/Technician and verify data is recorded accurately 4. Data entry personnel manually transcribe data from paper to database 5. Monitor compares database to paper records 6. Data entry personnel investigate and correct errors/discrepancies 7. PI reviews data 8. Reports are manually generated for each sponsor 6
- 7. PREVIOUS NEXT PREVIOUS NEXT Challengesof Historical Approach • Recruiting volunteers – Failure to recruit full subject groups can delay a trial and increase costs • Complex workflow – Data is collected at a rapid pace and in a highly structured manner, and trial design often changes • Scheduling studies – Lack of visibility into the availability of beds and staff to conduct each trial makes it difficult to bid correctly and maximize revenue 7
- 8. PREVIOUS NEXT PREVIOUS NEXT Challengesof Historical Approach (cont.) • Sample integrity – Need to collect samples on time, track their location, and store them properly to preserve data integrity • Evidence of processes – SOPs show planned processes; need contemporaneous data to provide evidence • Accurate data capture – Missing or erroneous data can invalidate results and necessitate a partial or complete repetition 8
- 9. PREVIOUS NEXT PREVIOUS NEXT EmergingTrend Toward Automation “Historically, these challenges have been addressed with increasingly intricate paper processes. These studies are, however, becoming more complex. The unit must accommodate the requirement that early phase trials deliver a first look at efficacy and stakeholders' desire to share data rapidly. Meanwhile, the units aim to take on larger numbers of studies. All of these factors are leading to the simple conclusion that paper processes are no longer practical.” -- Automating Phase I Trials, Applied Clinical Trials, 1 August 2010 9
- 10. PREVIOUS NEXT PREVIOUS NEXT OracleHealth Sciences LabPas • Flexibility – Early phase study protocols can change quickly – Last-minute setup, schedule, and barcode label changes easy to manage (even after study has begun) • Configurability – Define all the major elements of a study • Sample processing requirements, configuring edit checks, etc. – Expansive reporting and data export structure • Control – Designed to reduce errors and queries • Direct data capture • Sample processing automation • Real-time edit checks and alerts 10
- 11. PREVIOUS NEXT PREVIOUS NEXT KeyBenefits of LabPas • Subject Recruitment – Study volunteers recruited quickly with an easy-to-use customizable, scripted data collection wizard and appointment scheduling tools – Volunteers automatically evaluated based on configurable inclusion and exclusion rules • Direct Data Capture – Automation dramatically reduces the need for paper from clinical trials – Real-time study data collected and checked when the technician is with the subject; no delay in data entry or verification 11
- 12. PREVIOUS NEXT PREVIOUS NEXT KeyBenefits of LabPas (cont.) • Sample Management – Barcode-driven sample management efficiently captures data and controls sample process – Customizable edit checks and alerts reduce input and sample processing errors • Data Management – Data visualization, data review/approval, metrics and query management allow effective qualification of electronic source – Key decisions made earlier when real-time data is available to both investigators and sponsors • Reporting – Data can be evaluated and easily transferred to the sponsor with flexible reporting capabilities 12
- 13. PREVIOUS NEXT PREVIOUS NEXT Features& Functions of LabPas • Volunteer lookup based on demographics and clinical history • Volunteer screening, appointment scheduling, and screening data entry • Flexible study and data capture setup enables rapid configuration of study protocols • Barcodes labels (subjects, dosing, tubes, instruments) improve workflow 13
- 14. PREVIOUS NEXT PREVIOUS NEXT Features& Functions of LabPas (cont.) • Define multiple clinics to enable global early phase deployment strategies • Configurable security roles, electronic signatures, and a complete audit trail • Sample storage management and temperature monitoring 14
- 15. PREVIOUS NEXT PREVIOUS NEXT AnticipatedPhase I Trend • Phase I clinics will continue to automate their operations to differentiate themselves – More competitive bids – Higher quality data – Faster data sharing • Sponsors will continue to seek out phase I clinics that have automated processes – Time and cost savings – Increased compliance – Greater confidence in data, leading to better go/no-go decisions 15
- 16. PREVIOUS NEXT PREVIOUS NEXT Recommendationsfor a Phase I Solution • Minimum requirements should include: – Robust volunteer database – Call center scripts / decision trees – Automatic verification of study eligibility – Staff scheduling functionality – Screening event tracking – Electronic data capture on the clinic floor – Automatic edit checks – Sample tracking – Portal for sponsors to review data – Trusted/reliable software vendor 16
- 17. PREVIOUS NEXT PREVIOUS NEXT Thankyou for attending! Questions? 17
- 18. PREVIOUS NEXT PREVIOUS NEXT ContactUs • North America Sales Contact: – Rod Roderick – rroderick@biopharm.com – +1 877 654 0033 • Europe/Middle East/Africa Sales Contact: – Rudolf Coetzee – rcoetzee@biopharm.com – +44 (0) 1865 910200 • General Inquiries: – info@biopharm.com 18
- 19. PREVIOUS NEXT PREVIOUS NEXT Presenter– Param Singh • Contact – psingh@biopharm.com – +1 210 454 5192 Param has been working in the life sciences industry his entire career. As vice president of CTMS at BioPharm, he developed the CTMS practice to become one of the best in the industry. With a knack for resource and project management, Param leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. 19
- 20. PREVIOUS NEXT PREVIOUS NEXT Presenter– Ed Dougherty • Contact – ed.dougherty@oracle.com – +1 610 579 3705 Ed has over 17 years of experience in the life sciences industry, primarily focused on the clinical development space. For the past four years, he has been part of the Oracle Health Sciences Global Business Unit, supporting various clinical solutions, such as LabPas. Ed facilitates client discussions surrounding the benefits of Oracle Health Sciences applications through detailed presentations and workshops. 20