August 1 is World Lung Cancer Day, followed by Lung Cancer Awareness Month in November – both annual global observances designed to raise people’s awareness of lung cancer and how to prevent, detect, or treat it. Lung and bronchus cancer is reported to be the most common cause of cancer death in the United States and worldwide, making it an important and critical area for cancer research. Lung cancer is the cause of more deaths in this country than the next three most common causes of cancer death combined – colorectal cancer, breast cancer, and pancreatic cancer. Clinicaltrials.gov currently lists over 3,600 lung cancer trials either planned, recruiting or in progress.
In 2023, more than 238,000 people in the US will be diagnosed with lung and bronchus cancer and more than 127,000 people will die of the disease, according to estimates by the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program. The two primary forms of lung cancer are small cell lung cancer, which is the most common form of the disease, and non-small cell lung cancer.
While a cure is the ultimate goal, research has resulted in more effective treatments that are allowing many people to live with lung cancer longer – for ten years or more. The clinical studies research organizations are conducting are critical to better understanding cancer – how to prevent it, how to detect it early, how to treat it, and ultimately, identifying cures. Early detection is key to effective treatment, yet many people do not know they have lung cancer until it has advanced beyond an early stage. While chest x-rays haven’t been all that helpful for early detection, a relatively new test known as a low-dose CT (LDCT) scan has been studied in recent years with people at higher risk of getting lung cancer. LDCT scans can help detect abnormal areas in the lungs, which may be cancer. Unlike chest x-rays, research shows that yearly LDCT scans for people at higher risk of lung cancer can save lives.
The Mednet team is proud of our extensive experience working in oncology research, and we commend our CRO partners and clinical research sponsors for the exciting and innovative work they are doing to discover new therapies, treatments and cures for lung cancer and other cancers. Over the years, our team has supported hundreds of cancer research studies around the world. The types of oncology studies conducted on the iMednet platform are broad, ranging from small, early-stage biotech studies to large and complex late phase pharmaceutical trials.
Oncology studies bring unique challenges that require flexible technology solutions. For example, oncology registries can be especially challenging because there are many different types of treatment – chemo, radiation, surgery, hormone therapy, etc. – that can change at any point during the study due to a patient response and NOT a study protocol. Treatment cycles in oncology research can also complicate the study, as many times it is not known how many cycles a patient will undergo. For example, if they are having only partial response to treatment, but they are tolerating it well, it may be continued for a long time. However, in other instances, if “progressive disease” is indicated or they are experiencing an adverse event from treatment, treatment may need to be changed or even halted for a short time.
To address these complicated challenges and study designs, it’s critical to have a flexible and responsive technology solution. For example, iMednet’s dynamic grids are uniquely designed to address these complex study dynamics. Among other things, individual case report forms (CRFs) can be hidden in the grid, while treatment CRFs can also be hidden, with the exception of the actual treatment given.
Adaptive designs, common in oncology studies, represent a new level of complexity in clinical trials. Simultaneously, they demand a new level of flexibility that is required throughout study conduct. Mid-study modifications are typically based on rather complex computational algorithms. As designed, the changes must be implemented quickly, efficiently and accurately. Response adaptive randomization (RAR) or a sample size reassessment (SSR) are commonly used adaptive designs that require the research team to be able to assess data and formally implement mid-study changes. This new requirement has heightened the tug of war between the need to support greater trial complexity and the need for simultaneously greater user flexibility. Flexible and dynamic technology is critical to addressing these evolving needs.
Understanding the unique demands of oncology study designs is key to success. While many Mednet customers choose to use iMednet in more of a ‘self-service’ mode, our experienced team brings decades of experience conducting and managing oncology research projects. Individual team members also have experience working in clinical settings in oncology and even as a participant in an oncology research study. Given the unique considerations of oncology studies, this experience helps us support research teams most effectively, whether it is helping with a study build, training designers or simply providing end-user support. For example, a recent Mednet customer was running an oncology trial and requested additional study support. Having worked as a registered radiation therapist earlier in her career, a Mednet project manager was able to leverage her experience to help them create contracts and hire pathologists to perform independent biomarker reviews. She was also able to support them by reviewing biostats data and abstracts. We are proud to support our customers with deep experience in oncology research.
Having the right technology and experience can significantly streamline processes and improve efficiency in all studies, but particularly in complex oncology studies given their unique considerations. Furthermore, new data sources, real-world evidence and emerging study designs, such as decentralized trials, can significantly enhance and optimize studies, but they require flexible technologies. iMednet is a highly flexible EDC-centric platform and hundreds of oncology studies have been conducted using the technology. To learn more about Mednet’s flexible platform or our therapeutic expertise, contact us.