Adult Clinical Trial Participation

  • Charts and Tables

    Charts and Tables

    Figure 6.1

    Ratio of adult patients enrolled in clinical trials to number of incident cases, by province, all cancers — 2014 enrolment year

    * Suppressed owing to small numbers.
    “—” Data not available.
    Weighted Average excluded PE owing to small numbers.
    The Canadian Cancer Society’s (CCS) projected 2014 cancer incident cases were used for this indicator. CCS projections are derived from statistical models incorporating data obtained from the Canadian Cancer Registry, National Cancer Incidence Reporting System, Canadian Vital Statistics’ Death Database, and population life tables, censuses and forecasts.
    The indicator is a ratio, not a rate. As such, the numerator is not a complete subset of the denominator. Cases included in the numerator could have been diagnosed in previous years or could be recurrent cases.
    AB: Includes non-intervention cases.
    Data source: Provincial cancer agencies and programs; Canadian Cancer Society, Canadian Cancer Statistics.

    Data Table

    Province Number of patients enrolled in clinical trialsNumber of incident casesRatioLower bound of 95% confidence intervalUpper bound of 95% confidence interval
    AB1,08716,5000.0660.0620.07
    ON4,22173,8000.0570.0560.059
    SK1745,4000.0320.0280.037
    BC61624,3000.0250.0230.027
    MB1156,5000.0180.0150.021
    NB565,0000.0110.0080.015
    NS436,1000.0070.0050.009
    NL73,4000.0020.0010.004
    PE*****
    QC–––––

    * Suppressed owing to small numbers.
    “—” Data not available.
    Weighted Average excluded PE owing to small numbers.
    The Canadian Cancer Society’s (CCS) projected 2014 cancer incident cases were used for this indicator. CCS projections are derived from statistical models incorporating data obtained from the Canadian Cancer Registry, National Cancer Incidence Reporting System, Canadian Vital Statistics’ Death Database, and population life tables, censuses and forecasts.
    The indicator is a ratio, not a rate. As such, the numerator is not a complete subset of the denominator. Cases included in the numerator could have been diagnosed in previous years or could be recurrent cases.
    AB: Includes non-intervention cases.
    Data source: Provincial cancer agencies and programs; Canadian Cancer Society, Canadian Cancer Statistics.

    Figure 6.2

    Ratio of adult patients enrolled in clinical trials to number of incident cases, by disease site, four most common cancers and all cancers combined — 2014 enrolment year

    Data for 4 most common cancers are from BC, AB, SK, MB, NB, NS and NL.
    Data for all cancers are from BC, AB, SK, MB, ON, NB, NS and NL.
    The Canadian Cancer Society’s (CCS) projected 2014 cancer incident cases were used for this indicator. CCS projections are derived from statistical models incorporating data obtained from the Canadian Cancer Registry, National Cancer Incidence Reporting System, Canadian Vital Statistics’ Death Database, and population life tables, censuses and forecasts.
    The indicator is a ratio, not a rate. As such, the numerator is not a complete subset of the denominator. Cases included in the numerator could have been diagnosed in previous years or could be recurrent cases.
    Data source: Provincial cancer agencies and programs; Canadian Cancer Society, Canadian Cancer Statistics.

    Data Table

    Disease siteNumber of patients enrolled in clinical trialsNumber of incident casesRatioLower bound of 95% confidence intervalUpper bound of 95% confidence interval
    All cancers6,319141,0000.0450.0440.046
    Breast3508,6000.0410.0370.045
    Prostate2639,1800.0290.0250.032
    Colorectal1298,8300.0150.0120.017
    Lung968,9700.0110.0090.013

    Data for 4 most common cancers are from BC, AB, SK, MB, NB, NS and NL.
    Data for all cancers are from BC, AB, SK, MB, ON, NB, NS and NL.
    The Canadian Cancer Society’s (CCS) projected 2014 cancer incident cases were used for this indicator. CCS projections are derived from statistical models incorporating data obtained from the Canadian Cancer Registry, National Cancer Incidence Reporting System, Canadian Vital Statistics’ Death Database, and population life tables, censuses and forecasts.
    The indicator is a ratio, not a rate. As such, the numerator is not a complete subset of the denominator. Cases included in the numerator could have been diagnosed in previous years or could be recurrent cases.
    Data source: Provincial cancer agencies and programs; Canadian Cancer Society, Canadian Cancer Statistics.

  • About this indicator

    About this indicator

    Key message

    Clinical trial participation increased in five of eight reporting provinces from 2013 to 2014.

    Indicator definition

    The ratio of cancer patients aged 19 years or older who were newly enrolled in Phase 1 to 4 clinical trials† (e.g., cancer-related therapeutic clinical trials or clinical research studies) at provincial cancer centres in 2014 to the estimated number of new cancer cases in 2014. Results are reported by province and disease site.

    Measured since

    The 2010 Cancer System Performance Report.

    Why measure this?

    Patients who are treated in cancer centres with active clinical trial programs tend to have better health outcomes (e.g., improved survival and quality of life) than those treated in centres that do not participate in clinical trials. This finding is likely due to better processes and delivery of care, including treatment guideline concordance.1-4

    The cancer clinical trials system in Canada is facing difficulties for several reasons. These factors include increasing clinical trial complexity, a more onerous regulatory environment and increasing workloads for research ethics boards.5 In addition, although the number of cancer clinical trials opened per year remained the same or grew from 2000 to 2010, patient enrolment per year has plateaued or decreased.5 Comparing clinical trial participation across the country can identify opportunities for action.

    What are the key findings?

    • In the 2014 enrolment year, the clinical trial participation ratio ranged from 0.002 (interpretable as 0.2%‡) in Newfoundland and Labrador to 0.066 (6.6%) in Alberta (Figure 6.1). Compared with 2013, the clinical trial participation ratio increased in five of eight reporting provinces—British Columbia, Alberta, Saskatchewan, Manitoba and Ontario (data not shown).
    • The clinical trial participation ratios for the four most common disease sites ranged from 0.011 (1.1%) for lung cancer to 0.041 (4.1%) for breast cancer (Figure 6.2). Compared with 2013, the clinical trial participation ratios have decreased for breast, prostate and lung cancers and remained the same for colorectal cancer (data not shown).

    Why do these findings matter?

    Clinical trials are an essential step in evaluating the safety and effectiveness of emerging cancer treatments. They are also useful for identifying new ways to detect, diagnose and reduce the risk of cancer. Patients who take part in clinical trials contribute to the development and evolution of evidence-based cancer care. This research could lead to more and better options for screening, diagnosis, treatment and after-care, as well as improved outcomes for those affected by cancer.

    Evidence suggests that cancer centres with active clinical trial programs have better patient outcomes, such as improved survival.1-4 However, participant enrolment is the biggest barrier to completing clinical trials.6 The results presented here show that less than 7% of adults take part in clinical trials in Canada, which is similar to other countries, such as the United States.7 Comparing clinical trial participation across the country may be helpful in identifying opportunities for action. For example, provinces with higher clinical trial participation could share their experiences with improving accrual into cancer clinical trials.

    How does Canada stack up internationally?

    In the United States, the National Cancer Institute has estimated that fewer than 5% of adult cancer patients participate in clinical trials.7 In contrast, the United Kingdom had the highest rate of cancer clinical trial participation worldwide. The National Cancer Research Network was established in the United Kingdom in 2001 to enhance recruitment to trials and to other patient-centred research; its creation produced a doubling in clinical trial participation.8 In 2006, approximately 14% of adults diagnosed with cancer in the United Kingdom participated in cancer trials.

    In Canada, the Canadian Cancer Clinical Trials Network (3CTN) was founded in 2013 to coordinate clinical trial centres. The goal of the initiative is to improve patient access to academic clinical trials, to improve the environment for the conduct of academic clinical trials through collaboration and facilitation of important national trial initiatives, and to demonstrate the impact of the Network and academic trials on the Canadian health system.9

    Notes

    † Phase 1 trials are intended to measure safety and adverse effects of new drugs or treatments. Phase 2 trials continue to measure safety and further evaluate the effectiveness of drugs or treatments. Phase 3 and 4 trials are key to improving the health outcomes of enrolled patients. They are intended to evaluate side effects and associated long-term outcomes.1o,11

    ‡ As a proxy for the actual clinical trial participation rate, the results of this indicator can (for convenience only) be interpreted as percentages (e.g., 0.05 = 5%).

    References

    1. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better outcomes for patients treated at hospitals that participate in clinical trials. Arch Intern Med. 2008 Mar 24;168(6):657-62.
    2. Du Bois A, Rochon J, Lamparter C. Pattern of care and impact of participation in clinical studies on the outcome of ovarian cancer. Int J Gynecol Cancer. 2005 Mar-Apr;15:183-91.
    3. Du Bois A, Reuss A, Pujade Lauraine E, Harter P, Ray Coquard I, Pfisterer J. Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: A combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials. Cancer. 2009;115(6):1234-44.
    4. Selby P, Autier P. The impact of the process of clinical research on health service outcomes. Ann Oncol. 2011 Nov;22 Suppl 7:vii5-vii9.
    5. Canadian Cancer Research Alliance. Report on the State of Cancer Clinical Trials in Canada. Toronto (ON): 2011. 60 p.
    6. American Cancer Society. Why do we need clinical trials? [Internet]. [place unknown]: American Cancer Society; 2014 [updated 2014 Oct 31; cited 2015 Nov 23]. Available from: http://www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/whatyouneedtoknowaboutclinicaltrials/clinical-trials-what-you-need-to-know-why-do-we-need-clin-trials.
    7. Institute of Medicine (US) Forum on Drug Discovery D, and Translation,. Clinical Trials in Cancer. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (DC): National Academies Press; 2010.
    8. Sinha G. United Kingdom becomes the cancer clinical trials recruitment capital of the world. J Natl Cancer Inst. 2007;99(6):420.
    9. Canadian Cancer Clinical Trials Network. About Us [Internet]. Toronto (ON): Canadian Cancer Clinical Trials Network; [cited 2016 Feb 16].
    10. U.S. National Library of Medicine. Clinical Trial Phases [Internet]. Bethesda (MD): National Institutes of Health; 2008 [updated 2008 Apr 18; cited 2016 Feb 1]. Available from: http://www.nlm.nih.gov/services/ctphases.html
    11. ECRI. Patients' Reasons for Participation in Clinical Trials and Effect of Trial Participation on Patient Outcomes. Plymouth Meeting (PA): 2002 Apr. 38 p.
  • Data specifications

    Data specifications

    Definition: The ratio of the total number of all patients aged 19 years or older newly enrolled in cancer-related therapeutic trials or clinical research studies to the projected number of new incident cancer cases (all ages)

    Numerator: Number of cancer patients (≥19 years) newly enrolled in cancer-related therapeutic clinical trials or clinical research at provincial cancer centres. For patient enrolled in multiple clinical trials, all occurrences were counted

    Denominator: Projected number of new invasive cancer cases (all ages)

    Data source: Provincial cancer agencies (numerator), Canadian Cancer Statistics (denominator)

    Measurement timeframe: 2014 enrolment year

    Stratification variables: Province, disease site (breast, prostate, colorectal, lung, all cancers)

    Provinces submitting data:

    • All cancers: BC, AB, SK, MB, ON, NB, NS, PE and NL.
    • By disease site: BC, AB, SK, MB, NB, NS and NL

    Province specific notes:

    • AB: Included non-intervention cases

    Notes:

    1. Projected number of all invasive cancer cases excluded in site cases.
    2. Incident cases are estimated for all ages from the Canadian Cancer Statistics.
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