In the last ten years, the way oncology clinical trials are conducted has drastically shifted. At the same time, the amount of real-world data collected within oncology trials is skyrocketing. As the approach to cancer studies evolves, modern technology solutions pave the path for smoother and more efficient research.
In the past, oncology studies examined cytotoxic chemotherapy in largely histology-based populations, grouping patients by cell or tissue abnormalities. Now, these studies often use smaller subsets of patients to evaluate targeted agents and immune therapies against specific biomarkers.
This shift in approach requires researchers to change how they conduct oncology trials, including narrowing patient selection and endpoint determination, resulting in a more challenging recruitment process. To adjust for this shift, researchers now leverage adaptive designs, originally for rare disease research, in oncology clinical trials.
Many elements of oncology clinical research are complex, from study design to data analysis. The right technology solutions, however, can simplify oncology trial operations.
In this article, we will uncover:
- How to overcome enrollment and retention hurdles
- What solutions accelerate study timelines
- How to manage a global supply chain
Enrollment and Retention Hurdles
Because of limited patient populations and poor participants’ health, many oncology studies require multi-center sites, possibly spanning several countries, to meet enrollment targets. Phase III oncology trials include, on average, around 14 countries and 82 investigative sites.
Meanwhile, side effects of cancer treatments may make patients too sick to meet eligibility criteria. Similar to rare disease trials, oncology trials are more likely to face recruitment and retention challenges with patients geographically spread out and coping with serious illnesses.
Phase II and III oncology protocols are 1.5 times longer, on average, than non-oncology protocols. Notably, the widest differences observed were in the durations associated with patient enrollment, study conduct, and length of treatment periods.
Solution: Improving participant engagement and comprehension
One of the ways to help overcome enrollment hurdles is to embrace elements of decentralized clinical trials (DCT). Decentralized trials can reduce trial burden for participants and their caregivers by:
- Eliminating non-essential travel visits to treatment facilities
- Using telehealth technologies and electronic platforms to conduct remote informed consent discussions
- Enabling wearable technologies for data collection and using electronic patient-reported outcomes (ePRO)
- Supporting remote delivery of trial medications
- Enabling at-home collection services for correlative samples
The right participant-facing solutions, like eConsent and ePRO, can help to improve participant comprehension and retention while expanding geographic reach.
Study Timelines and Staff Turnover
According to the May-June 2021 Tufts CSDD Impact Report, oncology drug trials last 30 to 40 percent longer than trials for other drugs. The reason? More complex designs, longer treatment periods, and difficulty finding, enrolling, and retaining study volunteers.
Combined across phases, this translates to an oncology trial lasting 12 years on average, compared to around eight years for non-oncology trials.
The sheer length of oncology trials means a huge amount of data collection, along with more site staff turnover. Staff attrition worsened throughout the COVID-19 pandemic, with one cancer network reporting over 80% of its research sites experiencing personnel shortages.
Solution: Decentralized clinical trial elements
If a site experiences data collection overload and high turnover among site staff, integrated solutions that automate time-consuming manual processes are highly beneficial.
The right clinical data management system (CDMS) can integrate with other solutions to support clinical trial workflows, regardless of whether these are traditional, hybrid or decentralized, and maximize operational efficiency.
At the same time, automated processes can smooth out day-to-day site operations by:
- Streamlining consent and reconsent with electronic consent (eConsent) throughout oncology trials
- Reducing data entry and source data verification efforts with electronic clinical outcome assessments (eCOA)
- Automating visit and patient workflows through CDMS, eConsent, RTSM, and eCOA
Supply Chain Considerations
Investigational Products (IPs) used in oncology trials can be very costly and often have specific humidity and temperature requirements. Meanwhile, these products are needed at multiple sites, often spread across multiple countries, with different patient populations and different needs.
Understandably, it can be hard to allocate the correct resources to the right site at the best time. Therefore, supporting a coordinated, lean, and patient-focused dispensing plan involves aligning manufacturing, packaging, labeling, and demand-driven logistics. Sites need to avoid both waste and stock outages—which may prevent a patient from being treated.
Solution: Supply chain optimization
Supply chain technologies significantly reduce the risk and management burden of stocking sites. For example, a technology like Randomization & Trial Supply Management (RTSM) can ensure the right shipment containing the right IP from the appropriate source is generated at the right time.
If a shipment is taking too long, it can easily flag the problem and raise an alarm. A mature system can react to obstacles that affect trials – expiry events, damaged bottles, fridge breakdowns, delayed shipments, or temperature alerts.
There is also value in working with a supply chain partner for global trials. An experienced partner can help navigate customs, including export licenses. They can also help to raise a shipment, track it, and ensure it clears customs. This alignment ensures efficient inventory use while safely minimizing waste.
The Future of Oncology Trials
Currently, oncology drugs in Phase I have a 3.4% chance of ultimately receiving FDA approval. As science progresses and adaptive designs become more common, researchers must use strategies to support nimbler, faster trials with fewer participants. Meanwhile, researchers are realizing the need to offer participants more options, including fewer site visits.
Decentralized trial elements can support operational tasks that take site personnel away from higher-value activities, including patient care and engagement. At the same time, the right supply chain technology can support an efficient and low-waste flow of product.
With all these amazing technologies in the mix, our team at Medrio believes the future of oncology research is bright!