A4 - Adult clinical trial participation

A4 - Adult clinical trial participation 

Key Messages

•   Close to 150 trials are available across all cancer types and disciplines, including radiation oncology, medical oncology, and surgery, across the partner hospitals of the RCN. These can be viewed on the RCN web site.

•   Not all trials are available at all RCN partner hospitals. Patients can be referred to other hospitals within the RCN to access different clinical trials.

•   The RCN performs above the Canadian average for accrual of patients to treatment-based clinical trials. Overall, 6.5% of patients being treated at the partner hospitals of the RCN are enrolled in clinical trials versus 4.5% for the rest of Canada.  

•   Melanoma patients have the highest rate of clinical trial participation; 10.7% of melanoma patients are treated on a clinical trial.


Background

Patient participation and access to clinical trials is a key measure of the delivery of quality cancer care.1 Clinical trials allow earlier access to breakthrough treatments, and patients treated in cancer centres with active clinical trial programs tend to have improved outcomes (e.g., survival and quality of life) than those treated at institutions without clinical trials.2-4 This finding is likely due to better processes and delivery of care, including treating patients according to accepted guidelines and having access to new effective therapies.

The American Society of Clinical Oncology states that exemplary clinical trials sites should accrue at least 10% of treated patients onto treatment-based clinical trials.5 In Canada, the clinical trial participation ratio for all cancers for the 2014 enrolment year was 0.045 (4.5%).6  

What Do the Results Mean?

Across the partner hospitals of the RCN, the ratio of adult cancer patients who were newly enrolled in therapeutic clinical trials in 2016 to the number of new cancer cases is 0.065. This can be interpreted as 6.5% of patients participated in clinical trials in 2016. It should be mentioned that this was a time of significant transition, in which the McGill-wide Clinical Research Program was dismantled following changes in Quebec laws for ethical oversight of research. We anticipate that the recruitment numbers will be greater for 2017 as each hospital restores and revises their Clinical Research Programs.

Across the RCN, there are trials available for all the major tumour types. Patients with melanoma have the highest ratio of participation in clinical trials, with 10.7% of patients being treated as part of a clinical trial. Possible explanations include the close collaboration via a joint Cancer Diagnosis and Treatment Committee (tumour board) between the JGH and MUHC melanoma teams, as well as the recent availability of exciting new therapies for this cancer type, which are primarily available only as part of a clinical trial.

Within the RCN, there are close to 150 active trials. Descriptions of all trials accepting patients are publicly available on the RCN clinical trial web site. These are conducted by twelve different clinical research groups depending on the intervention, phase of the trial, and cancer type. For example, Phase 1 and 2 trials, which are complex and intended to measure safety, side effects and evaluate the effectiveness of drugs or treatment (Phase 2 trials), are conducted at the MUHC and JGH. Phase 3 and 4 trials, which are designed to assess the interventions’ value in clinical practice and measure long-term effects may additionally be conducted at SMHC. Different clinical trial groups manage radiation oncology trials and some cancer-specific trials.

Since not all trials are available at each hospital, the strength of the RCN as a network allows patients to be referred across the partner hospitals to access breakthrough treatments as needed.

Efforts

The RCN aims to achieve a recruitment activity of at least 10% in 2017. We propose to achieve this by improved awareness of clinical trials through the RCN web site, at Cancer Diagnosis and Treatment Committees (CDTCs), and by helping the referral of patients from one hospital to another through dedicated facilitators.

In addition, the Breast Disease Site Group has initiated a project to pre-screen all breast cancer patients prior to treatment for possible inclusion in a trial. We expect that these initiatives will significantly improve recruitment to trials in the coming years and at least for breast cancer patients, we aim to reach a 15% accrual target in 2019. 

Notes

Data Specifications

DEFINITION 

Ratio of the total number of all patients aged 19 years or older newly enrolled in cancer-related treatment-based clinical trials to the number of new incident cancer cases

SOURCE

Cancer registry, Clinical Research Groups

NUMERATOR

Number of cancer patients (≥19 years) newly enrolled in cancer-related treatment-based clinical trials at MUHC, JGH and SMHC. For patients enrolled in multiple clinical trials, all occurrences were counted.

DENOMINATOR

Number of new invasive cancer cases (≥19 years). In-situ cancer cases other than bladder were not included in the denominator. 

EXCLUSIONS

Patients enrolled in trials for cancer prevention, screening, diagnosis, quality of life, economics of care, biobanking and patient registries, were not included. 

MEASUREMENT TIMEFRAME

Yearly

NOTES

The definition used for patients enrolled was the following:

Number of patients who have been screened and registered in a treatment-based clinical trial. Screen failures were not counted. Withdrawals were included. For example: You screen 100 patients to enroll 25. 

References

1. ASCO-ESMO consensus statement on quality cancer care. J Clin Oncol 24:3498-3499, 2006.  

2. 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.

3. 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.

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. Zon R, Meropol N, Catalano R, et al: American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol 4:2562-2567, 2008

6. http://www.systemperformance.ca/cancer-control-domain/research/adult-cli...

References

1. ASCO-ESMO consensus statement on quality cancer care. J Clin Oncol 24:3498-3499, 2006.

2. 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.

3. 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.

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. Zon R, Meropol N, Catalano R, et al: American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol 4:2562-2567, 2008

6. http://www.systemperformance.ca/cancer-control-domain/research/adult-cli...

Disclaimer: The Rossy Cancer Network has attempted to ensure the accuracy of the data that it is reporting for each of its hospitals. Values posted on this web page may change as new information becomes available or corrections are made; this may alter accumulated values.

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