Twenty-one surveys were received from research coordinators at different disease sites. Of these 21, 6 surveys were from gynecologic malignancies, 5 from breast oncology, 3 from lung and head/neck malignancies, 4 from malignant hematology, 2 from gastrointestinal malignancies, and one from genitourinary malignancies.
Five main themes important to clinical trial enrollment were identified: clinical trials protocol, communication barriers and cultural beliefs, financial barriers, patients' comorbidities and performance status, and physicians’ commitment. Below we will describe the themes. Illustrative quotes are provided in Table 1.
A common obstacle encountered by our research coordinators pertains to the clinical trial schema and protocol requirements. Participants frequently reported that the inclusion and exclusion criteria are often overly strict. Furthermore, patients commonly tend to refuse to participate in clinical trials if additional biopsies are required.
Also, frequent laboratory testing and office visits often drive patients away from participation in clinical trials, concerns for affecting their work schedule and increase the time-off work to participate in such activities, especially if they live at a distance from the treating institution. Patients prefer a more flexible approach to treat their condition and preserve quality of life.
- Communication barrier and Cultural beliefs
Frequently reported, the communication barrier has been one of the difficult obstacles to overcome. If the patient is speaking a non-English language, commonly Spanish, that often excludes them from participating in clinical trials. The absence of language appropriate consent or the need to requesting institutional review board (IRB) approval of Spanish informed consent delays the enrollment procedure, the urgency to starting the treatment makes waiting to participate in the clinical trial an inferior option for the majority of our patients.
Cultural beliefs linked to the fear of receiving an investigational drug or a placebo are commonly encountered. Also, the common conception of being treated as a “lab rat” while participating in a clinical trial usually exists as a barrier for accrual. These cultural beliefs and misconceptions have also led to under representation of racial minorities in cancer clinical trials.
Patients refuse to participate in the clinical trial due to the concern of the additional financial implications that might fall with the additional office visits and laboratory testing, let alone arranging transportations for those visits may create an added barrier. Additionally, the legitimate concern of having extra days off work to accommodate the clinical trial office visits and laboratory testing, adding yet another layer of financial burden.
Disease burden affects the patients’ general performance status and subsequently excludes them from clinical trials. This barrier can often be counterintuitive to the patient’s ultimate well-being. As performance status limitations are often directly or indirectly related to their underlying malignancy, and in such settings, treating the underlying malignancy serves to improve their energy level and performance status. Also, comorbidities remain a common exclusion criterion.
Explaining the science behind the investigational agent, its mechanism of action, and the study hypothesis as well as disclosing benefit/risk balance while incorporating the financial burden and time commitment is crucial for clinical trial screening.
Due to the level of confidence and trust built between the primary oncologist and the patients/their families, the clinical trial is best introduced and explained by the treating physician, which requires physician enthusiasm and commitment as well as open communication with the research team.
- Clinical trials challenges in the midst of a pandemic:
During the COVID-19 pandemic, our research staff noted continued interest in clinical trials. However, patients express concerns over multiple in-person visits required on trial. Lack of education surrounding risks of admission vs risks of immunosuppression need to be addressed. Also screen failures have become more prominent throughout the pandemic as patients delay medical care until situation is urgent. This leads to a worsened disease burden, worsened performance status, organ dysfunction which disqualifies them from participation in many clinical trials.