Better treatments are needed to fight cancer, and therapeutic trials are the only effective means of identifying them. At our institution, approximately 6% of cancer patients participate in trials, only slightly higher than that of the national average. Therefore, we have worked to identify both patient and physician-related barriers to accrual. Physician-related barriers include a lack of knowledge regarding existing trials, lack of time to research eligibility, fear of "losing" their patient to a trial, and reluctance to support trial participation when standard treatment options are available (Links 1 and 2 below). For patients, it is exceedingly difficult to find up to date clinical trial information written for a lay audience, and as trial eligibility is becoming more focused on tumor genetics as opposed to the organ of origin, patients may be deterred from searching for studies which require such knowledge (ie. lung cancer patients not only have to know if they have small cell or non-small cell, but to focus trial options they may need to know their EGFR, KRAS or ALK status). Furthermore, patients may misunderstand or mistrust the complex process of clinical trial participation (Link 3). We are addressing these barriers so that our center can provide the most up-to-date and leading-edge care to our patients in the form of clinical trials. Lastly, as practitioners, we have a responsibility to arm patients with the knowledge of all potential treatment options, so they can make an informed decision about the direction of their care.
For our patient population, potential obstacles include discomfort using a web-based system, and lack of understanding regarding clinical trials as treatment options. If patients are uncomfortable with online communication, we will offer the study using a paper-based consent form and questionnaire. With regard to misunderstanding the purpose of cancer trials, we will provide online and in-person resources to educate patients on the principles of participation. Physician barriers may include concern about “losing” their patient to a trial, or potential expenditure of time researching eligibility once patients are aware that trials are valid treatment options. Since Research for Us methodology is completely patient-facing, we will be able to give patients trial match data they can share with their treating physician to keep them engaged, while taking the burden of trial-matching off the physician.
We anticipate a 15% increase in therapeutic clinical trial accrual within the first year of implementation, based on the success of our previous clinical trial matching study. We currently track all cancer clinical trial accruals at our institution via an online, secure clinical trial management system, Oncore®, and we are able to track the referral source for each.
Continual new accrual to Research for Us as well as annual updates to patient information will provide potential new matches on an ongoing basis. In addition, data queries will be run at different time points to capture patients who may have relapsed and therefore could potentially qualify for a new clinical trial.
We do not foresee any regulatory hurdles as we have been implementing a web-based registry since March 2013, and have been working closely with our Institutional Review Board (IRB), and our Information Technology and Legal departments to adopt online consenting and trial matching.
Our institution's initial web-based clinical trial matching registry was successful in matching 15% of its participants to studies, however as the registry was for any woman over 18 with or without cancer, it turned out it was only marginally successful in matching participants to treatment trials, as a large number of participants did not have cancer themselves but wanted to contribute in some way. For our new innovative solution, we are going to focus on increasing awareness of and access to therapeutic cancer clinical trials, for both men and women.