Breast Cancer Month: Better Trial Enrollment Rates Sorely Needed!

Despite an extremely encouraging 38% decrease in mortality since 1989, Breast Cancer remains the most common type of cancer in the US. Indeed, it is estimated that in 2017, there will be 252,710 new cases of invasive breast cancer and over 40,000 breast cancer deaths among US women. These numbers highlight that:

• The medical community is successfully introducing new treatment regimens for women afflicted with Breast Cancer
• Much more needs to be done to decrease the number of deaths due to Breast Cancer

To address the latter point, the medical research community is relentlessly working on novel treatments that must be validated through clinical trials in order to bring efficacious ones to market. Unfortunately, despite an increase in the number of clinical trials conducted nationwide, less than 5% of women with breast cancer enroll in them.

Over the years, a number of reasons have been attributed to the lack of breast cancer clinical trial enrollment. These include mistrust of the health care system, patient bias against clinical trials, other comorbidities, insurance difficulties related to either the lack of or the presence of a non-comprehensive policy coverage, transportation issues and restrictive eligibility criteria.

Other reasons affecting enrollment are inherently related to the disease itself:

• New Breast Cancer drugs and modalities (i.e. immunotherapy) may have secondary effects that could alter the patients’ quality of life, like pneumonitis, pancreatitis, skin rashes, nausea and vomiting, diarrhea or constipation, mouth sores, shortness of breath or trouble breathing, cough, chronic fatigue and headache
• Since many of the novel proposed treatment regimens are administered in combination, clinical trials are designed with growing complexity. Thus, potential Breast Cancer patients are increasingly reluctant to enroll due to overwhelming complexity of trial procedures
• Early stage Breast Cancer patients have a relatively high rate of success following current treatment options. In contrast, patients with more advanced disease – and fewer standard treatment options – are more likely to consider clinical trials compared to those with earlier stages of the disease. This leads to lower participation numbers in trials targeting early stages of the disease, which in turn affects the timeline and success of those trials and delays potential successful treatments from reaching the public in time before the disease evolves to later and more invasive stages

These enrollment issues are complex and far-reaching. As a response, studies have repeatedly emphasized that the best way to mitigate this complexity is through robust patient education. A recent prospective patient survey highlighted that public education on the true value of clinical research and the reality of participating in a clinical trial is seriously lacking. Therefore, involving trained patient advocates at each step of the clinical research process, even in pre-clinical phases, could provide significant benefit in helping to design informative trials, as well as recruit patients to participate.

For example, many of those cancer patients presented common misconceptions about clinical trials like confusing sham treatment with no treatment when in reality it represents the currently approved standard of care. Educating this group of patients about comparing new drugs to actual standard care drastically alleviated their concerns. As a proof of principle, another study clearly showed significantly enhanced participation due to increased involvement of well trained and informed nurses in explaining clinical trial options to the patients.

Barriers that keep clinical trial participation low should and can be broken. The Breast Cancer community as a whole, including patients, medical professionals, advocates, families and friends should unite behind the common goal of increasing education for patients to enhance clinical study enrollment and participation, which can bring us closer to identifying better treatment options.