Leukemia is a broad umbrella term referring to cancers that originate from abnormal blood-forming cells in the bone marrow. Of all new leukemia cases expected to occur annually in the United States, 15% are classified as chronic myeloid leukemia (CML). Whereas acute myeloid leukemia is easier to treat, CML remains undetected for longer periods and is a result of cancerous myeloid progenitor cells, which later mature into red blood cells or platelets. Based on data from 2012 to 2018, the overall 5-year survival rate for CML patients was about 70%.
Biopharma and biotech sponsors are bringing much-needed treatment options into the market. This is especially life-changing for CML patients, many of whom have successfully overcome their CML because of the drug options that chronic myeloid leukemia clinical trials gave them. Granted, these trials naturally come with a number of obstacles. In this next installment of Vial CRO’s Oncology Trial Management series, we present the top 5 challenges sponsors face when running chronic myeloid leukemia clinical trials and how to overcome them.
1 | Efficient Project Management
It’s very easy for sponsors to spread their resources too thin by overestimating their project timelines and underestimating how typical challenges will affect their clinical trials. To avoid running into unexpected delays, the first step should be to set realistic expectations by predicting what your project’s weaknesses may be. From creating a multi-pronged recruitment campaign to combat slow enrollment to eliminating slow paper-based documentation processes, your study’s journey to startup will be smoother because the biggest pitfalls have been accounted for in the project timeline. Visit Vial CRO’s article here to learn more about these pitfalls and how you can prepare against them.
2 | Controlling Protocol Complexity
Each year, a little over 8000 patients are newly diagnosed with CML in the U.S., but it’s safe to say that not all these patients will require or even respond to the same type of treatment approach. In oncology especially, trying to account for so many unknowns can quickly result in an excessively complex protocol. Sponsors should keep in mind which procedures are essential to meet objective endpoints and which may needlessly increase the trial burden. Although non-traditional designs are often well-suited for cancer research, project managers should also prepare for these studies to take longer, cost more per participant, and require better trained site personnel to remain protocol-compliant.
3 | Conducting Geriatric Research for Chronic Myeloid Leukemia Clinical Trials
Considering more than 50% of CML cases affect individuals older than 65 years, sponsors must find ways to circumvent the common challenges of working with geriatric populations. This can be started by designing the study’s eligibility criteria to allow for potential candidates to be assessed on an individual basis, rather than being screened out by generalized vulnerability criteria. Remote visit options or travel accommodations can also help ease the burden of frequent site visits. Lastly, sponsors should tailor how they spread information to these patients because certain digital recruitment strategies may not cater well to older adults aged 70-90 years.
4 | Managing Study Costs
With the cost of developing cancer drugs easily surpassing hundreds of millions of dollars, chronic myeloid leukemia clinical trials will no doubt cause a significant financial burden for sponsors. These expense increases result from maintaining multiple sites around the world, having to sustain a long study duration, and supporting each recruited participant. There are numerous approaches for reducing your study costs, such as minimizing administrative tasks, optimizing patient recruitment, and fixed-fee pricing models from CROs. Visit our full article here to learn five proven strategies that can make your study more affordable.
5 | Addressing Technology Needs
New technologies in the field of pharmaceutical research have consistently been pouring in recently. While this comes with exciting new opportunities, they also come with its own challenges, such as requiring new training for clinical study staff, especially those who have been in the field for many decades. Partnering with tech-enabled contract research organizations (CROs), like Vial, can ease the transition for sponsors. Not only can these CROs provide a streamlined suite of clinical trial platforms, as well as engaging training materials for site staff. Visit https://vial.com to find out how we’re leveraging digital innovation to support sponsors.
The Vial Oncology CRO
Oncology research can be a complicated maze to navigate, but Vial Oncology CRO has you covered. Our clients benefit from our next-generation approaches to clinical research, led by a team of expert professionals with specialized experience in cancer studies. Connect with a team member today to learn how working with us can get you ahead with your next clinical trial!