Blog Entry: December 20, 2011
We know that fewer patients participating in clinical trials leads to a delay in the innovation of needed therapies and reduces access to additional treatment options with novel compounds. The dismal rate of accrual of patients to cancer clinical trials can be attributed to a number of barriers. Our work needs to focus on simultaneously addressing these barriers from the patient perspectives, oncologists/oncology practices, and referring providers. We need to remind ourselves that the low accrual is not just due to patient related barriers. Through addressing barriers associated with procedures, practices and policies as well lead to a major impact to increase in accrual.
WHAT IS GOING ON FOR PATIENTS? Patients may not choose to be part of cancer clinical trials for a number of reasons. The perception of being a “guinea pig”, fear of randomization, concerns over the use of placebo, or potential adverse events all could dissuade a patient. However, these barriers are assuming 1) the patients are even offered participation in a clinical trial and 2) the patients understand that the clinical trial is an option for treatment and are making a truly informed decision. . In a survey conducted in the early 2000s, 85% of cancer patients were not aware of cancer clinical trials, and 75% of them said they were willing to participate if they would have been aware of the opportunity. A more recent study in California found approximately 50-80% of patients were eligible for a cancer clinical trial and were not enrolled.
WHAT IS GOING ON IN THE ONCOLOGY PRACTICE? Why should the onus to learning about trials only be placed on the patient? Often not discussed or evaluated are the barriers associated with the providers. Oncologists are concerned with the lack of time and resources to find a clinical trial, identifying eligible patients, explain protocols and adverse events, as well as other research related work. In addition, there is also a concern around the researchers’ perception of certain patients being difficult or non compliant. This particularly impacts the minority and underserved population. Then there are procedures in the practice that can also create barriers. The relationship between the research nurse, clinical nurse, and physician is important. A lack of adequate communication between these staff members can lead to a lack of knowledge of what clinical trials are open for the treating physicians to present to patients and missed opportunities of eligible patients for the research nurses. Finally, procedures within the practices could hamper attempts to obtain patient friendly consent forms, and lead to inefficient procedures which could delay opening needed clinical trials.
WHAT IS GOING ON FOR REFERRING PROVIDERS? The question arises, should the referring providers discuss clinical trials as something to mention prior to referral? Primary care providers can inform patients of the availability of cancer clinical trials and encourage patients to enquire about them. This could be key to help enhance accrual, because primary care providers can be seen as a trusted person for the patient. However, primacy care providers rarely discuss the topic of cancer clinical trials with their patients. Of the primary care physicians surveyed in a NCI study, 37% were not aware of any clinical trials that may be available for their patients and few knew where to get such information. Also, 41% prefer to leave the discussion about clinical trials be with the oncologist, but the oncologist do not always provide the cancer clinical trials as an option.
It seems easier to focus on the patient not joining a clinical trial or not wanting to be in a clinical trial, but there are a lot of barriers in the system before a patient is even approached.
Oncology Practices should take a look at their internal processes and evaluate what they could do better to identify and approach patients. Oncologists can begin with assessing their practice to increase efficiencies associated with the communication within the treatment team or community network to identify patients. What gaps exists within the current processes and procedures that allow potential patients to be missed? How can the practice address them?
Primary care providers and other referrers can become more aware of clinical trials occurring in their region by connecting with the local oncology practices and familiar with the various clinical trial resources available. They can also start informing patients that cancer clinical trials are a potential treatment option.