clearing the hurdles of early phase cdm
TRANSCRIPT
Worldwide HeadquartersMayfield Heights, Ohio 888.677.DATA (3282) Toll Free
Bryan, Texas 979.393.9020Cary, North Carolina919.651.0222www.datatrak.net
Clearing the Hurdles of Early Phase CDM
Bill O’MaraManager, Clinical Data Management
DATATRAK, INC
• Phase 1 Background • Phase 1 Types and Definitions • Phase 1 Players• Phase 1 Challenges• Time Saving Strategies• EDC vs Paper
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Agenda
Phase 1 Background• Phase 1 studies are the first stage of drug trials in
humans.• Typically most Phase 1 trials occur in small
populations of healthy volunteers.• Often they occur at an inpatient clinic allowing for
less variables in the study of the drug.
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DATATRAK Confidential from Concept to Cure™ www.datatrak.net
Common Phase 1 Trials• First in Man/Single Ascending Dose (SAD)• Multiple Ascending Dose (MAD) • Drug/Food Metabolic Interaction Studies• Through QT
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Definitions– Bioavailability: The extent to which a nutrient or medication can
be used by the body
– Bioequivalence: A measure of the equivalence of two or more drugs.
– Pharmacokinetics: What the body does to the drug
– Pharmacodynamics: What the drug does to the body
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Phase 1 – Players• Clinical Pharmacology• Kineticist • Bioanalytical Labs• Phase 1 Clinics
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Phase 1 Communication• Identify and discuss the most relevant topics during
team meetings.• Follow CDM SOPs and best practices and try to avoid
study specific practices.• Identify central team members and communicate
with them regularly.
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Challenges • Accelerated Timelines• Protocol Amendments• Study Team Members less educated about CDM
process • Multiple studies often being conducted
simultaneously• Small Study Teams
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Time Saving Strategies Study Startup:• All normal Start-up documents still required.
Standard templates can and should be created. • Use CDASH as a basis to create a library of standard
forms. Protocol specific forms can be created and inserted as needed.
• Utilize SAS listings, manual review to save time on edit check development and validation.
• Review CRFs/eCRFs as well as documents with entire team during a meeting.
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Time Saving Strategies Study Maintenance:• Review data as often as possible. Data is often
entered daily and can change quickly.• Dependent upon the population be vigilant of SAEs,
possible coding issues and abnormal lab data.• Ensure all external data transfers arrive on time and
are consistent with previous data.
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Time Saving Strategies Study Closure:• Be prepared for a strong push for data to be available
immediately. Cleaning the data and reconciling any external data prior to data freeze will help considerably.
• If applicable be sure to review PK collection dates and times to ensure a clean PK data merge by the statistical programmers.
• Try to establish Data Finalization timelines as a team.
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EDC vs PaperPaper:
Advantages:– Lower in cost– Shorter Study Start-up Time (initially)
Disadvantages:– No access to on-demand data– Study Close-out time will be greatly increased
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EDC vs PaperEDC:
Advantages:– Data can be provided on demand– Data Freeze can occur within days of the final monitoring
visit.
Disadvantages:– New processes and training must occur– Initial timeframes and cost will be greater
DATATRAK Confidential from Concept to Cure™ www.datatrak.net
References• Roy, K. “Bioavailability & Bioequivalence
Pharmacokinetic Principles.” Retrieved from www.icmcc.org/ppt/roy.ppt
• Wikipedia. http://en.wikipedia.org/wiki/Clinical_trial#Phase_I
DATATRAK Confidential from Concept to Cure™ www.datatrak.net
Worldwide HeadquartersMayfield Heights, Ohio 888.677.DATA (3282) Toll Free
Bryan, Texas 979.393.9020Cary, North Carolina919.651.0222www.datatrak.net
Thank You!Bill O’MaraManager, Clinical Data ManagementDATATRAK, [email protected]