eligibility: the deciding factor

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Eligibility: The deciding Eligibility: The deciding factor factor

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Eligibility: The deciding factor . Eligibility Criteria. Select subjects that are as homogenous as possible Control and build variables into the design of the study Answer the trials hypothesis and meet written objectives Patient safety. Eligibility Criteria The Good, The Bad and The Ugly. - PowerPoint PPT Presentation

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Page 1: Eligibility: The deciding factor

Eligibility: The deciding factor Eligibility: The deciding factor

Page 2: Eligibility: The deciding factor

Eligibility CriteriaEligibility Criteria

Select subjects that are as homogenous as possibleSelect subjects that are as homogenous as possible Control and build variables into the design of the Control and build variables into the design of the

studystudy Answer the trials hypothesis and meet written Answer the trials hypothesis and meet written

objectivesobjectives Patient safetyPatient safety

Page 3: Eligibility: The deciding factor

Eligibility CriteriaEligibility CriteriaThe Good, The Bad and The UglyThe Good, The Bad and The Ugly

Writing eligibility criteria is an art:Writing eligibility criteria is an art: Must not be overly restrictiveMust not be overly restrictive Must not be overly vagueMust not be overly vague Must be verifiableMust be verifiable Must be based on “reasonable” practice Must be based on “reasonable” practice

parametersparameters Must not be excessive in numberMust not be excessive in number

Page 4: Eligibility: The deciding factor

Eligibility Criteria Eligibility Criteria The Good, The Bad and The UglyThe Good, The Bad and The Ugly

Overly Restrictive:Overly Restrictive:

Must be 18 years of ageMust be 18 years of age

HIV test within 14 days of study entryHIV test within 14 days of study entry

Page 5: Eligibility: The deciding factor

Eligibility Criteria Eligibility Criteria The Good, The Bad and The UglyThe Good, The Bad and The Ugly

Overly Vague:Overly Vague:

Patients on anticoagulation therapy are allowed Patients on anticoagulation therapy are allowed to have an to have an appropriately prolongedappropriately prolonged International Normalized Ratio (INR)International Normalized Ratio (INR)

Page 6: Eligibility: The deciding factor

Eligibility Criteria Eligibility Criteria The Good, The Bad and The UglyThe Good, The Bad and The Ugly

Difficult to verify:Difficult to verify:

THE GOLDEN RULETHE GOLDEN RULE If the investigator feels that it is important If the investigator feels that it is important

enough to list it as a stand-alone criterion, an enough to list it as a stand-alone criterion, an audit should feel that it is important enough to audit should feel that it is important enough to source verifysource verify

Page 7: Eligibility: The deciding factor

Eligibility Criteria Eligibility Criteria The Good, The Bad and The UglyThe Good, The Bad and The Ugly

Difficult to verify:Difficult to verify:

History of XXX lesion with History of XXX lesion with large necrotic large necrotic areasareas, , as determined by the Principal as determined by the Principal InvestigatorInvestigator

Life expectancy of >12 weeksLife expectancy of >12 weeks

Page 8: Eligibility: The deciding factor

Eligibility Criteria Eligibility Criteria The Good, The Bad and The UglyThe Good, The Bad and The Ugly

Reasonable practice parametersReasonable practice parameters::

Patient Patient must be willing to stay must be willing to stay within 5 miles within 5 miles of the hospital and of the hospital and return daily return daily for labs.for labs.

Page 9: Eligibility: The deciding factor

Eligibility Criteria Eligibility Criteria The Good, The Bad and The UglyThe Good, The Bad and The Ugly

Excessive number:Excessive number:

Average number of eligibility criteria per Average number of eligibility criteria per protocol is 28 protocol is 28

Page 10: Eligibility: The deciding factor

Source Document:Source Document:

In a clinical trial, In a clinical trial, source documentssource documents are the are the hard copies on which clinical observations are hard copies on which clinical observations are first recorded. They are legally valid raw data first recorded. They are legally valid raw data that support a study’s findings.that support a study’s findings.

Page 11: Eligibility: The deciding factor

What What Source DocumentsSource Documents Do We Look for Do We Look for When Assessing Eligibility?When Assessing Eligibility?

Histology: Histology: CT/CXR, MRI, PET scans: CT/CXR, MRI, PET scans: Labs: Labs:

Page 12: Eligibility: The deciding factor

What What Source DocumentsSource Documents Do We Look for Do We Look for When Assessing Eligibility?When Assessing Eligibility?

For compound criteria:For compound criteria: Histologically or cytologically documented Histologically or cytologically documented

adenocarcinoma of the pancreas adenocarcinoma of the pancreas not amenable not amenable to surgical resectionto surgical resection: :

Page 13: Eligibility: The deciding factor

What What Source DocumentsSource Documents Do We Look for Do We Look for When Assessing Eligibility?When Assessing Eligibility?

For the “vague-ities”:For the “vague-ities”:

Patients have Patients have recoveredrecovered from any surgical from any surgical procedure procedure

Page 14: Eligibility: The deciding factor

What What ParametersParameters Do We Look for When Do We Look for When Assessing Eligibility?Assessing Eligibility?

Did all testing meet the assigned value/intent of Did all testing meet the assigned value/intent of the criteria? the criteria? (CT measurements, labs)(CT measurements, labs)

Did on-study note clearly address each “non-Did on-study note clearly address each “non-measurable” criteria? measurable” criteria? (date since last chemo, PS, con meds, etc).(date since last chemo, PS, con meds, etc).

If patient did not meet criteria was wiaver If patient did not meet criteria was wiaver appropriately used ? appropriately used ? (NCI)(NCI)

Page 15: Eligibility: The deciding factor

AUDITING HINTSAUDITING HINTS Eligibility criteria are critical; take them seriouslyEligibility criteria are critical; take them seriously Read the protocol, know the criteriaRead the protocol, know the criteria Develop a tool to capture componentsDevelop a tool to capture components

--Study calendar (when things --Study calendar (when things should should occur)occur)--Table--Table--Excel spreadsheet--Excel spreadsheet

Calendar for time patient is on trial Calendar for time patient is on trial (when things (when things actuallyactually occur) occur)

Review how research nurse captures data and sets up Review how research nurse captures data and sets up research filesresearch files

Create uninterrupted timeCreate uninterrupted time

Page 16: Eligibility: The deciding factor

DEAL or NO DEAL ?DEAL or NO DEAL ?

YOU DECIDEYOU DECIDE

Page 17: Eligibility: The deciding factor

Criteria:Criteria:

Ambulatory, medically stable persons; Ambulatory, medically stable persons; community dwelling; able to give informed community dwelling; able to give informed consent and available for all study visits; able consent and available for all study visits; able to understand and comply with planned study to understand and comply with planned study procedures; ECOG performance status procedures; ECOG performance status << 2. 2.

Page 18: Eligibility: The deciding factor

Criteria:Criteria:

Patients may have received one systemic Patients may have received one systemic chemotherapy regimen for XXXX tumor. chemotherapy regimen for XXXX tumor. There is no limit to the number of biological or There is no limit to the number of biological or immunotherapeutic regimens received by immunotherapeutic regimens received by patients.patients.

Page 19: Eligibility: The deciding factor

Criteria:Criteria:

Total bilirubin is less than or equal to 1.5 times the institutional upper limit of normal, SGOT less than or equal to 1.5 times the institutional upper limit of normal.

Page 20: Eligibility: The deciding factor

CriteriaCriteria

Patients with active infectionPatients with active infection

Page 21: Eligibility: The deciding factor

Criteria:Criteria:

History of History of psychiatric illness/social situationpsychiatric illness/social situation that would limit compliance with study that would limit compliance with study requirementsrequirements

Page 22: Eligibility: The deciding factor

POINTS TO REMEMBERPOINTS TO REMEMBERYour role as an auditor is to:Your role as an auditor is to: Verify that the investigator is enrolling only eligible Verify that the investigator is enrolling only eligible

subjects subjects [GCP 5.18.4 (i)][GCP 5.18.4 (i)] Protect the rights/well-being of human subjectsProtect the rights/well-being of human subjects Ensure the integrity of the dataEnsure the integrity of the data Verify that the conduct of the protocol is consistent Verify that the conduct of the protocol is consistent

with the IRB approved protocol, all federal and state with the IRB approved protocol, all federal and state regulations, GCP guidelines and institutional policy.regulations, GCP guidelines and institutional policy.

Not stated = not verifiedNot stated = not verified

Questionable data = unacceptable lossQuestionable data = unacceptable loss

Page 23: Eligibility: The deciding factor

PRACTICE TIMEPRACTICE TIME