Clearing the Hurdles of Early Phase CDM

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

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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, Incbill.omara@datatrak.net