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A total of 3-5 % of all cancer patients annually enroll in clinical trials worldwide. This statistic has not improved since the 1980s.
A total of 140 oncology patients were considered for initiation of or a change in systemic therapy during the period of assessment. Nineteen CCTs were open for recruitment (clinical studies =74%, translational studies = 26%). Five trials closed and no trials opened during the study period. The CCTs were available for 10 different cancer types and included a variety of stages of disease and lines of treatment. The median age was 60.5 years. The majority of patients were aged between 36 and 65 years (60%). A third were aged greater than 65 years (36.4%) and 5 patients were aged less than 35 years old. The majority of the population was female (66%) and Caucasian (100%). Breast and colorectal cancer were the most common cancer types represented within the population accounting for 37% and 25% of the cancer diagnoses respectively. The group was evenly split as regards cancer stage (early stage, (48%), advanced disease, (52%)). This division was reflected in the lines of treatment under consideration: adjuvant, (29.3%), neo-adjuvant, (17.1%) and palliative treatment including: 1st line, (21.4%), 2nd line, (11.4%) or 3rd line/higher, (20.7%). Less than a third (29%) of the population had a CCT option available to them. The treating physician considered the CCT option in the majority of cases (63.4%). The option of CCT participation was discussed with the patient in just over half (54%) of these cases. The reasons for failure to discuss the trial option included physician’s discretion; patient ineligibility; and patient previously declined enrolment in the CCT. A total of 8 patients agreed to participate in a CCT.
There was no CCT option available for the majority of the population (71%). The absence of a trial for a specific cancer type, stage of disease and line of treatment were the most common reasons underlying the limited CCT options available to this population. The accrual rate to a CCT for this period of study was 5%, which is in line with international figures. This study highlighted multiple factors to explain the failure to recruit to CCTs
The authors assert that poor accrual to CCTs is one of the rate limiting factors for continued progress in cancer care. In order to safeguard continued advancement, regular evaluation of factors influencing accrual to CCTs is necessary. This study identifies a 5% accrual rate to CCTs, which is comparable to internationally reported figures. However, this accrual rate is low and the authors declare that we must strive for better. Regular auditing is encouraged to ascertain if targets are being reached. Possible interventions to promote recruitment to CCTs include: gap analyses, physician champions and appropriate diversification of the clinical trial portfolio.
This study identifies the lack of a CCT option as the main reason for failure to recruit to CCTs. Absence of a trial protocol available for a specific cancer type, stage of disease and line of treatment were the three most common reasons why patients did not have the option to participate in a CCT. This problem is not unique to Ireland. The availability of CCTs is dependent on the total number of trials offered by a CTU. The obvious solution to the recruitment issue would be to open more studies. However, the running of a CTU is costly and there are many practical barriers that influence patterns of recruitment to CCTs. The cost per trial participant in many studies is often much higher than the per-case study reimbursement offered. The shortfall incurred by CTUs creates difficulty for them to run cost-neutral or cost efficient research programs. This financial strain limits the ability of sites to open new studies. Maintaining compliance with regulations that oversee the conduct of clinical trials, adhering to codes of good clinical practice and providing the intense patient monitoring and follow-up required by clinical trial protocols are labour intensive. Funding for CTUs is often dependent on the number of study participants enrolled in the previous year. However, increasing the accrual rate to CCTs increases the workload, which can strain a workforce of already limited resources.
Clinical Trials Ireland (previously known as the All Ireland Co-operative Clinical Research Group (ICORG)) coordinates cancer clinical trials in Ireland.