Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials

Raoul Tibes, Barbara F. Piper, Jessica A. Smith, Raysenia L. James, Martin A. Benjamin, Jay H. Yim, Ramesk K Ramanathan, Daniel D. Von Hoff, R. Curtis Bay, Mitesh J Borad

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Backkground: Increasingly, early phase clinical trials involve pharmacodynamic (PD) and pharmacokinetic (PK) assays as well as frequent imaging studies. The authors conducted a prospective study examining patients' willingness to undergo such tests and the number of tests the patients would tolerate. Methods: A prospective, correlative study was conducted using a self-reported questionnaire to measure patients' willingness on a scale from 1 (not willing) to 10 (very willing) to undergo various procedures (eg, tumor and skin biopsies, blood tests) and imaging studies (eg, magnetic resonance imaging, echocardiogram). In addition, correlations were assessed between the number and type of tests and demographics, previous test experience, inconvenience, and insurance coverage. Sixty-one patients (22 women and 39 men) with advanced malignancies were enrolled. Descriptive, nonparametric, and parametric inferential statistics were used. Results: Overall willingness to undergo study-required tests was very high. Patients were most willing to undergo urine, blood, ultrasound, x-rays, echocardiogram, and computed tomography studies and were least willing to undergo tumor and skin biopsies and magnetic resonance imaging (all P â01). Significant inverse relations were observed between the frequency of a particular test and patient's willingness to undergo such tests. Inconvenience and prior negative experiences for more invasive tests (eg, skin biopsies) modestly affected willingness to undergo these tests again. College education, insurance coverage, and the requirement of tests for enrollment were correlated positively with willingness to undergo tests. Conclusions: The current findings provide the first prospectively collected data on patients' willingness to undergo PK/PD tests and imaging studies associated with early stage oncology drug trials and can serve as basis for further exploration toward the design of patient-friendly, biomarker-driven clinical studies in oncology.

Original languageEnglish (US)
Pages (from-to)3276-3283
Number of pages8
JournalCancer
Volume117
Issue number14
DOIs
StatePublished - Jul 15 2011

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Pharmacokinetics
Insurance Coverage
Biopsy
Magnetic Resonance Imaging
Prospective Studies
Neoplasms
Skin
Hematologic Tests
Skin Tests
Biomarkers
Tomography
X-Rays
Demography
Clinical Trials
Urine
Education
Pharmaceutical Preparations

Keywords

  • clinical trials
  • oncology
  • pharmacodynamic markers
  • phase 1

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Tibes, R., Piper, B. F., Smith, J. A., James, R. L., Benjamin, M. A., Yim, J. H., ... Borad, M. J. (2011). Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials. Cancer, 117(14), 3276-3283. https://doi.org/10.1002/cncr.25885

Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials. / Tibes, Raoul; Piper, Barbara F.; Smith, Jessica A.; James, Raysenia L.; Benjamin, Martin A.; Yim, Jay H.; Ramanathan, Ramesk K; Von Hoff, Daniel D.; Bay, R. Curtis; Borad, Mitesh J.

In: Cancer, Vol. 117, No. 14, 15.07.2011, p. 3276-3283.

Research output: Contribution to journalArticle

Tibes, R, Piper, BF, Smith, JA, James, RL, Benjamin, MA, Yim, JH, Ramanathan, RK, Von Hoff, DD, Bay, RC & Borad, MJ 2011, 'Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials', Cancer, vol. 117, no. 14, pp. 3276-3283. https://doi.org/10.1002/cncr.25885
Tibes R, Piper BF, Smith JA, James RL, Benjamin MA, Yim JH et al. Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials. Cancer. 2011 Jul 15;117(14):3276-3283. https://doi.org/10.1002/cncr.25885
Tibes, Raoul ; Piper, Barbara F. ; Smith, Jessica A. ; James, Raysenia L. ; Benjamin, Martin A. ; Yim, Jay H. ; Ramanathan, Ramesk K ; Von Hoff, Daniel D. ; Bay, R. Curtis ; Borad, Mitesh J. / Patient willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials. In: Cancer. 2011 ; Vol. 117, No. 14. pp. 3276-3283.
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abstract = "Backkground: Increasingly, early phase clinical trials involve pharmacodynamic (PD) and pharmacokinetic (PK) assays as well as frequent imaging studies. The authors conducted a prospective study examining patients' willingness to undergo such tests and the number of tests the patients would tolerate. Methods: A prospective, correlative study was conducted using a self-reported questionnaire to measure patients' willingness on a scale from 1 (not willing) to 10 (very willing) to undergo various procedures (eg, tumor and skin biopsies, blood tests) and imaging studies (eg, magnetic resonance imaging, echocardiogram). In addition, correlations were assessed between the number and type of tests and demographics, previous test experience, inconvenience, and insurance coverage. Sixty-one patients (22 women and 39 men) with advanced malignancies were enrolled. Descriptive, nonparametric, and parametric inferential statistics were used. Results: Overall willingness to undergo study-required tests was very high. Patients were most willing to undergo urine, blood, ultrasound, x-rays, echocardiogram, and computed tomography studies and were least willing to undergo tumor and skin biopsies and magnetic resonance imaging (all P {\^a}01). Significant inverse relations were observed between the frequency of a particular test and patient's willingness to undergo such tests. Inconvenience and prior negative experiences for more invasive tests (eg, skin biopsies) modestly affected willingness to undergo these tests again. College education, insurance coverage, and the requirement of tests for enrollment were correlated positively with willingness to undergo tests. Conclusions: The current findings provide the first prospectively collected data on patients' willingness to undergo PK/PD tests and imaging studies associated with early stage oncology drug trials and can serve as basis for further exploration toward the design of patient-friendly, biomarker-driven clinical studies in oncology.",
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AU - Yim, Jay H.

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N2 - Backkground: Increasingly, early phase clinical trials involve pharmacodynamic (PD) and pharmacokinetic (PK) assays as well as frequent imaging studies. The authors conducted a prospective study examining patients' willingness to undergo such tests and the number of tests the patients would tolerate. Methods: A prospective, correlative study was conducted using a self-reported questionnaire to measure patients' willingness on a scale from 1 (not willing) to 10 (very willing) to undergo various procedures (eg, tumor and skin biopsies, blood tests) and imaging studies (eg, magnetic resonance imaging, echocardiogram). In addition, correlations were assessed between the number and type of tests and demographics, previous test experience, inconvenience, and insurance coverage. Sixty-one patients (22 women and 39 men) with advanced malignancies were enrolled. Descriptive, nonparametric, and parametric inferential statistics were used. Results: Overall willingness to undergo study-required tests was very high. Patients were most willing to undergo urine, blood, ultrasound, x-rays, echocardiogram, and computed tomography studies and were least willing to undergo tumor and skin biopsies and magnetic resonance imaging (all P â01). Significant inverse relations were observed between the frequency of a particular test and patient's willingness to undergo such tests. Inconvenience and prior negative experiences for more invasive tests (eg, skin biopsies) modestly affected willingness to undergo these tests again. College education, insurance coverage, and the requirement of tests for enrollment were correlated positively with willingness to undergo tests. Conclusions: The current findings provide the first prospectively collected data on patients' willingness to undergo PK/PD tests and imaging studies associated with early stage oncology drug trials and can serve as basis for further exploration toward the design of patient-friendly, biomarker-driven clinical studies in oncology.

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