Why is enrollment in potentially life-extending cancer trials so low?
Researchers have analyzed data on over 12 million individuals with various cancers and determined that following cancer diagnosis, enrollment in clinical trials as the first course of treatment is as low as 0.1%, despite the potential gain in life expectancy that trial participation may confer.
Researchers from the Penn State Cancer Institute (PA, USA) have analyzed data on more than 12 million individuals, with 46 different cancers, and determined enrollment in clinical trials as the first course of treatment following cancer diagnosis to be as low as 0.1%, despite the potential gain in life expectancy that trial participation may confer.
Senior study author Niraj Gusani (Penn State College of Medicine) commented on the troubling nature of this finding: “Major advances in cancer treatment have been supported by clinical trials. By volunteering to participate in a trial, patients may help further the field of research and gain access to new treatments.”
In this novel stratified analysis, investigators matched each study subject who participated in a cancer clinical trial as the first course of treatment following cancer diagnosis with an individual who did not participate in a clinical trial, but was phenotypically similar with respect to factors including age, race and disease type and stage.
Commenting on this study design, lead study author Nicholas Zaorsky (Penn State College of Medicine) explained: “If you're going to evaluate whether clinical trial enrollment is beneficial for patients, you have to try and match each patient to someone who has a similar cancer and sociodemographic profile. Otherwise, it is like comparing apples to oranges.”
Researchers observed that of the 12,097,681 eligible study subjects identified in The National Cancer Database, 11,576 – equivalent to 0.1% – enrolled in clinical trials as a means of receiving first-line treatment following diagnosis.
Individuals who had metastatic cancer types, were white, had private healthcare insurance and displayed fewer comorbidities were more likely to enroll in clinical trials compared with remaining study participants.
Enrollment in a clinical trial following diagnosis was associated with statistically significantly greater overall survival measures at 5 years.
Gusani noted: “If clinical trials are going to be used to determine standards of care for the general population, then the study participants need to be representative of the general population – and this study shows that often this isn't the case.”
The authors note several barriers currently hindering patient enrollment in clinical trials, including the present infrastructure of clinical trial design and management and the stigma associated with participation.
Zaorsky concluded: “The increased level of quality control in clinical trials may be beneficial…Patients who go onto a clinical trial must be treated per protocol, meaning that there are many quality measures that must be met, and that there are many other health care providers looking over the patient's care.”
Zaorsky NG, Zhang Y, Walter V et al. Clinical trial accrual at initial course of therapy for cancer and its impact on survival. J Natl Compr Canc Netw. doi:10.6004/jnccn.2019.7321 (2019) (Epub ahead of print);