jeffery wong, clinical research coordinator, nucleus network ltd

T16 Phase I studies – Phase I units and you, a Phase I unit’s expectation – A Day in the Life of a Phase I Study Coordinator

Jeffery Wong, Clinical Research Coordinator,

Nucleus Network Ltd

A Day in The Life of A Study Coordinator

• Main objectives:– To create awareness and a better understanding

of a Phase I clinical research co-ordinator’s (CRC) role

– To provide an understanding of the intensity of Phase I clinical trials

– To highlight some of the differences between Phase I trials and later phase trials


Clinical

Research

Co-ordinator

Principal Investigator Ethics

Committee

Technical/ Study

Logistics

Recruitment/Screening

Clinical Trials Pharmacy

Data Management

Subjects/Participants

Commercial Sponsor


Principal Investigator• Report and discuss any adverse events as well as

any subject safety concerns. - Daily updates if conducting MAD study

• Provide PI with periodic update on study progress.

Ethics Committee• Prepare ethics submission package in conjunction

with Project Manager• Provide safety updates, submit amendments and

obtain approvals. i.e. fortnightly safety reports.• Provide annual progress reports.


Commercial Sponsor• Provide updates to Sponsor/CRA pertaining to

recruitment and progress of study.• Clarify specific protocol requirements i.e.

inclusion/exclusion criteria, study procedures.• Confirm timeline for DSMB and the data required for

evaluation. DSMB meetings could be fortnightly.• Provide daily AE and safety lab updates via email.• SAE reporting.


Recruitment/Screening• Ensure adequate subjects are recruited for each study

including availability of alternate subjects. • Up to 4 – 6 volunteers being screened daily• Average screening window is 28 days

• Ensure exclusion/inclusion criteria are clear to minimise ratio of screen failures.

Patient/Subject• Ensure subjects’ compliance and their understanding

of each study’s requirements.• Ensure subjects’ safety and comfort whilst participating

in a study i.e. laundry, catering, entertainment etc.


Technical/Study Logistics• Ensure study related samples i.e. PK, PD and PGx

are appropriately processed and shipped to specified destination as indicated in study protocol.

• Shipment could occur on the same day after last sample is collected.

• Liaise with technical lead to ensure study laboratory requirements are adequate.

• Liaise with other contracted laboratories i.e. Melbourne Path, Alfred Path etc.

• Short turnaround time for results.


Clinical Trials Pharmacy• Provide prescriptions to Clinical Trials Pharmacy for

dispensing of IP – Dispensing of IP could take place on the morning of dosing.

• Ensure proper destruction/return of IP post dosing – IP accountability.

Data Management• Ensure completeness of source documentation. • Ensure CRF transcription is performed in a timely

manner in accordance with pre-defined timelines.• Ensure open queries are resolved.


Scenario Study 1: Dosing Day• Very intense with all activities running by the clock.

– Triplicate ECGs, Supine/Seated/Standing vitals, multiple blood sampling time points

• Every team member needs to know their role and be on stand by to provide assistance.

• Every change in circumstances result in a chain reaction i.e. delay in dosing.

• Food effect trials have additional concerns i.e. meal times & type of food.

• Sponsors may witness dosing or require verbal updates on day of dosing.


Day 1 1001 1002 1003 1004 1005 1006BREAKFAST 7:00 7:20 7:40 8:00 8:20 8:40Chest Auscultation 7:10 7:30 7:50 8:10 8:30 8:50IOP Assessment 7:15 7:35 7:55 8:15 8:35 8:55Subject Supine/Remove water 7:20 7:40 8:00 8:20 8:40 9:00Predose Vitals/Oximetry 7:23 7:43 8:03 8:23 8:43 9:03Predose ECG 7:26 7:46 8:06 8:26 8:46 9:06LFT Assessment 7:30 7:50 8:10 8:30 8:50 9:10End of Predose PK urine 7:35 7:55 8:15 8:35 8:55 9:15Predose PK/ Safety 7:50 8:10 8:30 8:50 9:10 9:30End of Dose 1 8:20 8:40 9:00 9:20 9:40 10:00(IPD) PK Blood IPD IPD IPD IPD IPD IPD(IPD) Oximetry IPD IPD IPD IPD IPD IPD5min PK Bood 8:25 8:45 9:05 9:25 9:45 10:0510min PK Blood 8:30 8:50 9:10 9:30 9:50 10:10

15min Chest Auscultation/AE Check 8:32 8:52 9:12 9:32 9:52 10:1215min Oximetry 8:33 8:53 9:13 9:33 9:53 10:1315min PK Blood 8:35 8:55 9:15 9:35 9:55 10:15Subject Supine 8:37 8:57 9:17 9:37 9:57 10:1730min ECG 8:40 9:00 9:20 9:40 10:00 10:2030min LFT Assessment 8:45 9:05 9:25 9:45 10:05 10:2530min PK Blood 8:50 9:10 9:30 9:50 10:10 10:301hr Chest Auscultation 9:10 9:30 9:50 10:10 10:30 10:50Subject Supine 9:12 9:32 9:52 10:12 10:32 10:521hr Vitals Signs/AE Check 9:15 9:35 9:55 10:15 10:35 10:551hr ECG 9:17 9:37 9:57 10:17 10:37 10:571.0hr PK Blood 9:20 9:40 10:00 10:20 10:40 11:001.0hr LFT Assessment 9:25 9:45 10:05 10:25 10:45 11:051.5hr PK Blood 9:50 10:10 10:30 10:50 11:10 11:30Subject Supine 10:14 10:34 10:54 11:14 11:34 11:542.0hr ECG 10:17 10:37 10:57 11:17 11:37 11:572.0hr PK Blood/AE Check 10:20 10:45 11:05 11:25 11:45 12:052.5hr PK Blood 10:50 11:10 11:30 11:50 12:10 12:30Subject Supine 11:14 11:34 11:54 12:14 12:34 12:543.0hr ECG 11:17 11:37 11:57 12:17 12:37 12:573.0hr PK Blood 11:20 11:40 12:00 12:20 12:40 13:003.5hr PK Blood 11:50 12:10 12:30 12:50 13:10 13:30Subject Supine 12:11 12:31 12:51 13:11 13:31 13:514.0hr Vital Signs/AE Check 12:14 12:34 12:54 13:14 13:34 13:544.0hr ECG 12:17 12:37 12:57 13:17 13:37 13:574.0hr PK /Safety Blood 12:20 12:40 13:00 13:20 13:40 14:00IOP Assessment 12:25 12:45 13:05 13:25 13:45 14:05LUNCH 12:30 12:50 13:10 13:30 13:50 14:10

Fig 1. Study Task Pad


Scenario Study 2: Source notes documentation• Multiple data points due to assessment intensity.

– 100 – 200 data points from predose to 1st hr post dose.

• Documentation involves entry from multiple study personnel (entire study team).

• Medical history and concomitant medication records are usually brief compared to later phase trials i.e. several volumes.


Fig 2. Source Notes


Scenario Study 3: Data Management• QC performed on source documentation prior to being

monitored.• More and more sponsors are requesting real time data

entry.• CRA may need to come in and perform SDV whilst data

is being entered into the CRFs.• Lab results are transferred electronically – dose

escalation evaluation.• Tight timeline for query resolution before data base lock.


Conclusion• Men can multitask too! Old myth is busted.• The success/smooth running of an early phase trial

relies heavily on team effort hence clear communication line is imperative.

• Early phase trials are intense hence study protocol clarity is essential to ensure expectations could be met.

• Main differences between Phase I trials and later phase trials are the intensity and study timelines.

jeffery wong, clinical research coordinator, nucleus network ltd

Documents

study progress

progress of study

study protocol

study procedures

study laboratory requirements

study coordinatorjeffery

later phase trialsa

intensity of phase