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Basic Data Collection Elements in Cancer Clinical Trials

Basic Data Collection Elements in Cancer Clinical Trials. Julia Challinor, RN, PhD University of California, San Francisco INCTR Annual Conference 10-12 December 2005 Chennai, India. U.S. National Cancer Institute Cancer Therapy Evaluation Program (CTEP) General Guidelines.

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Basic Data Collection Elements in Cancer Clinical Trials

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  1. Basic Data Collection Elements in Cancer Clinical Trials Julia Challinor, RN, PhD University of California, San Francisco INCTR Annual Conference 10-12December 2005 Chennai, India

  2. U.S. National Cancer Institute Cancer Therapy Evaluation Program (CTEP) General Guidelines • Do not abbreviate • For example drug names, can be misinterpreted • Use methotrexate – not MTX • Do not use brand names • Generic names are standardized • Extraneous information is not helpful • If using only injectable drugs, do not include instructions for oral doses (http://ctep.cancer.gov/handbook/append_16.html, retrieved 3/8/04)

  3. CTEP • Use consistent notation • Use EITHER qidOR Q6hdo not use both • Spell out the word “units” • A “u” can look like a zero • Never put a zero after a decimal point • Use 2 NOT 2.0 • A decimal point can be missed and result in a 10-fold dose increase (http://ctep.cancer.gov/handbook/append_16.html, retrieved 3/8/04)

  4. CTEP • If using units that are less than the number one, then a zero should precede the decimal point • 0.50mg should be used, NOT .50mg • Otherwise the decimal might be missed and result in a 10-fold dose increase • Calculation of body weight should be specified and formula used for calculation should be included • Identify if actual, ideal or lean body weight is used to calculate drug dosage (http://ctep.cancer.gov/handbook/append_16.html, retrieved 3/8/04)

  5. CTEP • Specify total number of days a drug is given and include cycle days when treatment occurs. • Specify contiguous treatment days and non-contiguous treatment days • Specify cycle (or course) duration • Clearly identify the duration of the administration of the drug • If given more than once a cycle, clearly describe the cycle days when the drug is given (http://ctep.cancer.gov/handbook/append_16.html, retrieved 3/8/04)

  6. CTEP • Be clear about total dose per treatment course • Use total dose as function of body weight or surface area • If appropriate, describe administration starting days and times. • Using a 24 hour clock notation, i.e. 1430 avoids errors using am and pm. (http://ctep.cancer.gov/handbook/append_16.html, retrieved 3/8/04)

  7. Vocabulary • Toxicity • “Toxicity is NOT clearly defined by regulatory organizations” • “Toxicity has been described as an adverse event that has an attribution (the relationship to investigational agent) of possible, probable or definite” • If the study specifies using a specific Adverse Event criteria (i.e. NIH) do NOT change the criteria during the course of data collection (http://ctep.cancer.gov/handbook/append_16.html, retrieved 3/8/04)

  8. Adverse Event (AE) • Definition • “A negative experience encountered by an individual during the course of a clinical trial, that is associated with the drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction.” Ginsberg, D, ( 2002) The Investigator’s Guide to Clinical Research, 3rd ed., p 283

  9. Adverse Event (AE) Terminology • Grading is from 1 to 5 • Grade 1 Mild AE • Grade 2 Moderate AE • Grade 3 Severe AE • Grade 4 Life-threatening or disabling AE • Grade 5 Death related AE

  10. Adverse Event Grading Example ANC is “Absolute Neutrophil Count LLN is “Lower Limit of Normal”

  11. Potential Problems • Terms must be defined in study PROTOCOL • Examples • Date of Registration • Is this the first day the patient was seen? • Is this the date they were given a medical record number? • Is this the date they were enrolled in the study?

  12. Potential Problems • Date of Informed Consent • Is this the date the patient/parent signed the consent? • Date of Enrollment • Is this the date the patient signed the consent? • Is this the date the patient began therapy?

  13. Potential Problems • Date of Birth • This is NOT the age of the child • The date of birth MUST be consistent • In the U.S. it is standard to use month/day/year • In Europe and Latin America it is standard to use day/month/year • Ideally, the data form or case report form will be designed with the format CLEARLY indicated • DOB (DD/MM/YYYY) • Best to use all 4 numbers for year, i.e. 1953, or 2004

  14. Potential Problems • Date Abandoned care • Missed one appointment? • Missed two appointments? • Refused treatment at diagnosis? • Went to a different center for treatment? • Disappeared for 2 months and then returned?

  15. Potential Problems • Subject Identifiers (subject ID) • Many hospitals have their own patient identification numbers • Using the hospital patient identification number as the subject ID can provide a path back to the patient for verification of data entry if a future problem or question arises.

  16. Classification • Disease classification should be standardized among protocol collaborators • Once a classification system has been selected, all participants should use identical diagnostic procedures as outlined in the study PROTOCOL

  17. Empty Fields • If a data field is EMPTY then it is assumed that the data entry was incomplete and the event did NOT occur! • ALL fields should have data input • If the data is “not applicable” then it should be noted as N/A (or by the chosen notation for not applicable) • If the data is “unknown” then it should be noted as UNK (or by the chosen notation for unknown)

  18. History Log • If there is a need to deviate from the case report form fields for ANY reason, there must be a history log that explains the reasoning.

  19. Problems • Physicians using their own “style” to make clinical notes • Language is not uniform • Patient information detailed is different from physician to physician • Nutritionist uses different abbreviations for medical terms than nursing or physicians.

  20. Problems • Just because the protocol states that a patient/subject should receive a specific chemotherapy/medication on a specific date within their cycle does NOT mean they received it! • the medication on that date • the dose specified on the protocol • the chemotherapy/medication AT ALL • e.g., physician orders are not the source document for chemotherapy received by patients in reality

  21. Problems • NO white out • NO colored pens • NO pencil • NO invented vocabulary • NO acronyms or unique site specific abbreviations

  22. Problems • Healthcare staff does not understand or believe in the importance of data collection • Too little time for careful data entry • Patient demands too high for good data collection • Charts are missing or moved • Temporary staff working on the oncology unit • Have not received training regarding clinical research protocol based treatment basics

  23. Data is important, it helps us get from here to………………….…there!

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