The Role of Clinical Trials and the Path Ahead

October is Breast Cancer Awareness Month, yet the significant impact of this disease is felt worldwide each day. According to the World Health Organization, breast cancer is the most common form of cancer globally. In 2020 alone, 2.3 million women received a breast cancer diagnosis.

Clinical trials continue to play an essential role in finding new treatment options for the many forms of breast cancer. Decades of research have helped explain the pathways, early signs, preventive measures, and options for treatment, but the fight against breast cancer is far from over.

Despite the enormous and constantly evolving body of breast cancer research, the National Cancer Institute reports that breast cancer accounts for 15.2% of all new cancer cases and 7.1% of all cancer-related deaths in the United States. These figures indicate there is still a considerable need for additional clinical research. Clinical trial sponsors and contract research organizations (CROs) have a critical role in expediting the processes involved with breast cancer studies. These 2 industry stakeholders are responsible for the inner workings of clinical trials, and both can help the fight against breast cancer by designing and operating patient-centric trials. This approach benefits participants, researchers, sponsors, and CROs by addressing the many factors resulting in clinical trial delay and failure.

The Significance of Clinical Trials in Breast Cancer Research

Breakthroughs in research have greatly influenced the vast information currently known about breast cancer. Clinical studies have transformed how breast cancer is prevented, identified, and treated. Successful clinical trials improve patient outcomes, so trial administrators must ensure participants receive appropriate support at trial enrollment.

Researchers, participants, trial sponsors, and CROs must work together from trial protocol design through to completion. Trial facilitators must ensure that participant welfare remains at the top of their priorities during all trial phases. As trial participants are being studied for developing drugs and therapies, the teams supporting them must embrace the delicate balance of keeping the trial on track while mitigating the emotional, physical, and financial toll on participants.

Current Challenges in Breast Cancer Clinical Trials

Breast cancer clinical trials often face many logistical difficulties, including recruitment, retention, lengthy timelines, and high costs that study delays can exacerbate.

The American Society of Clinical Oncology reports that although over 95% of patients who have cancer do not participate in clinical trials, 70% of all Americans are anticipated to be “inclined or very willing to participate” in a trial. By evaluating these figures, it is no mystery that recruitment for cancer trials is often a strenuous process.

Patiens with breast cancer are not being successfully recruited for or retained throughout a clinical trial because of the same barriers found in many other types of studies, which include financial burden, exclusionary eligibility criteria, travel and time commitment, and difficulties connecting health care providers and patients to studies.

Financial burdens and travel-related logistics are widely cited as barriers to enrollment and a later cause of dropout of patients and caregivers. In an independent study by Clincierge, 62% of patients and 59% of caregivers stated that travel-related challenges and the subsequent financial implications of participation prevented them from joining a trial.

CROs: Who They Are and Current Challenges in Trials

CROs provide research management and support for the pharmaceutical and biotechnology companies sponsoring a clinical trial. Their expertise, resources, and capabilities drive efficient, safe, and compliant studies.

CROs can make or break a trial based on their ability to help recruit, retain, and advocate for participants while staying on deadline and keeping up with demand for efficient operations. CROs work to improve participants’ lives, but trials are costly, so they often struggle with prioritizing efficiency over patient-centric methods. A recent study shows that between $50 billion and $60 billion is spent annually on failed oncology trials. This high cost may indicate why CROs may prioritize efficient medical and scientific research over proper patient support.

CROs also work to orchestrate effective communication between trial participants and researchers to ensure appropriate follow-up data are collected and appropriately utilized. Their support can contribute to increased patient engagement and an overall positive trial experience.

How CROs Can Streamline Trials

CROs can be a significant agent of change when it comes to streamlining clinical trials while providing a high level of support for participants. For example, CROs and their trial sponsors can invest in patient concierge services for participants. These types of support networks help address common barriers, such as difficulties in planning and executing travel logistics and navigating the trial reimbursement process. A Clincierge research study revealed that 95% of patients said having a single point of contact to support them throughout a clinical trial was crucial.

Recruitment and retention challenges are often better addressed by utilizing patient care coordinators who work with participants to remove the assumed and actual barriers to trial participation. These support services make the participants feel more secure and safe throughout the entire study, resulting in improved patient outcomes and better data collection. Trial sponsors and CROs save the monies associated with participant dropout and no longer need to begin enrollment halfway through a study. Singular points of contact help mitigate the confusion when too many study stakeholders attempt to conduct various data collections and follow-ups.

Bottom Line

If breast cancer clinical trials are better optimized to benefit the participants first, it can be a win-win for study sponsors and CROs. When studies are conducted with efficiency and patient outcomes are treated as mission critical, more significant progress can be made in the fight against this debilitating and often deadly disease. Successful trials benefit participants, trial sponsors, CROs, and even future generations of patients with breast cancer by enabling us to learn more about new treatment options and their efficacy.

Breast Cancer Awareness Month runs from October 1-31 each year. Click to learn more about how the National Breast Cancer Coalition is making strides in breast cancer research, advocacy, and finding new treatments for future generations.