Clinical trials are the gold-standard tool for driving evidence-based medical research today. With the benefits they can present patients, participation in trials should be included as a viable healthcare option, particularly in oncology where treatments are limited. Their potential for reducing treatment cost burdens for patients and advancing the field of oncology makes cancer trials a valuable pursuit in clinical research. This oncology trial management series will present approaches for running successful studies in different cancer types. In this first installment, we look at how sponsors can best ensure the success of their breast cancer clinical trials.
Understanding Breast Cancer
Breast cancer is the second-most common cause of cancer death in women, with over 200,000 cases being diagnosed and nearly 50,000 women dying of it every year in the United States; it is also important to note that about 2400 men are also affected annually. Depending on the malignant cell type in question, this disease comes in many forms, including ductal or lobular carcinoma, double- or triple-negative breast cancer, and inflammatory breast cancer. The general prognosis of breast cancer will depend on multiple factors such as tumor size, age at diagnosis, hormone receptor status, and more.
Considering the Impact of Disease Experience in Breast Cancer Trial Designs
With the large range of heterogeneity in the clinical presentation of breast cancer, sponsors must clearly define their research objectives during the initiation and planning stages of clinical trial project management. There is a continuum of different clinical study types which can be conducted for diseases like this, including treatment, epidemiological, screening, and survivorship trials. More importantly, the patient’s experience with breast cancer, including its impact on their quality of life, must be considered when creating a study protocol. Breast cancer patients experience a number of common symptoms while following standard treatment. Many of these can be exacerbated during participation in a clinical trial if sponsors don’t adopt a patient-centric design:
- Fatigue and bone health problems make frequent travel to on-site study visits difficult
- Challenges with memory and concentration may decrease compliance with complex protocols
- Emotional distress could be worsened by excessive procedure burden
As with any clinical trial, the best practice for ensuring smooth project management during a study is to take the necessary precautions long before patient enrollment begins.
Tailoring Engagement Strategies to Accommodate Breast Cancer Patients
One of the most challenging aspects of running a clinical trial is keeping recruitment and retention numbers up. In the case of breast cancer, previous research has demonstrated that mass mailing clinical trial information to patients of hospital or state cancer registries was a more successful strategy to bring in potential participants than materials provided to breast cancer clinics or support groups. Nonetheless, local partnerships with oncology clinics, hospitals, and community organizations cannot be discounted as a valuable method to increase recruitment for a breast cancer clinical trial. Additionally, once a patient is enrolled, the sponsor and site must also maintain their retention in the study. Considerations such as travel reimbursements, lodging assistance, options for remote clinical visits, and designing patient-friendly protocols will go a long way in improving a subject’s breast cancer clinical trial experience.
Breast Cancer Clinical Trial Site Requirements
In addition to the usual responsibilities of sponsors when conducting complex oncology studies, one of the most critical factors for success is choosing quality sites to participate in. Selected investigators should have extensive experience with clinical oncology, especially female breast cancer, to ensure participants receive appropriate medical care within the trial. Site staff should be closely familiar not only with standard trial conduct but also with safety reporting guidelines because serious adverse events can be more frequent in cancer trials. During site selection, sponsors should take steps to assess whether a potential site has access to the study’s target patient population, as well as local laboratories and medical imaging facilities. Choosing the most well-suited clinical sites ultimately helps ensure better data collection and provides the recruited patients with a more smoother trial experience. Working with a trusted contract research organization (CRO) that specializes in oncology can help with securing vetted sites experienced with breast cancer.
Oncology CRO for Breast Cancer Clinical Trials
An oncology contract research organization (CRO) is a company that assists biotechnology, pharmaceutical, and medical device manufacturers with oncology research services on a contract basis. Oncology CRO services provided for breast cancer may be niche, limited to specializing in biostatistical advice, management of regulatory affairs, or pharmacovigilance, or may provide a full range of services for clinical trial management from the selection of clinical sites and investigators, to supporting patient recruitment, safety surveillance, clinical monitoring, site audits, project management, data management, and biostatistics. Oncology CROs also help support oncology research institutions, universities, and government organizations.
Manage a Successful Breast Cancer Clinical Trial
As the most common type of cancer affecting women in the US, breast cancer clinical trials are essential for improving upon current therapies available to patients. Managing clinical programs for this disease is undoubtedly challenging, but there are key measures that can be taken to avoid common pitfalls as the study progresses. By integrating the patient perspective into their study design and fully vetting potential sites, sponsors can improve their chances of stronger enrollment, better data collection, and market approval.
The Vial Oncology CRO
The Vial Oncology CRO is changing today’s clinical research experience with its advanced network of specialized medical experts, experienced project managers, and in-demand clinical research sites. Vial has extensive experience in various categories of small molecules and biologics across a broad spectrum of cancer indications, including breast, prostate, lung, melanoma, leukemias, lymphomas, multiple myeloma, and adrenal gland, and more. Our next-generation Oncology CRO is powered by technology that streamlines processes and workflows leading to faster, more efficient clinical trial results at more affordable rates with fixed-fee pricing.