In the developed world, 1 in 4 people die from cancer or cancer-related disease, and cancer accounts for 13% of deaths globally.
Oncology is the fastest growing therapeutic area by revenue and number of clinical trials. There’s been a huge emphasis on developing new treatments to improve survival in patients with cancer, but these trials have become a costly undertaking for sponsor companies.
In general, clinical trials can be slow to complete and expensive to conduct when recurring issues are not swiftly and adequately remedied. The unexpected variables can then lead to:
- Inefficient trial design
- Low patient recruitment
- Difficulties with data collection and interpretation
- Sponsor or site budget restraints
These concerns are further multiplied in oncology trials, since they require even greater investments of money, time and (human) resources. Planning and executing oncology trials can quickly become complex, mainly for the following reasons:
- Budgets: Phase 2 and 3 oncology trial budgets are nearly double those of non-oncology trials, per patient enrolled.
- Timelines: Regardless of phase, oncology trials, last 14-18 months longer than non-oncology trials. (So extra delays would cause budget over-runs).
- Safety: Oncology safety monitoring is complex due to the volume and uniqueness of adverse events, and the Common Terminology Criteria for Adverse Events (CTCAE) grading requirement.
- Complex investigational products and protocols: Oncology uses complex protocols that can require the use of:
- Biologics (e.g. immuno-oncology drugs)
- Precision medicine
- Specialty lab vendors for: PK, pathology, genetic testing/deep sequencing, etc.
- Personal devices and monitoring tools: ePRO (electronic patient reported outcome)
- Companion Diagnostics etc.
- Comparator drugs: Oncology trials must almost always use comparator drugs over placebo. These comparators are standard-of-care therapies that have complex administrations and adverse events of their own.
- Global sites with varying regulatory and ethics requirements for:
- Visit assessments
- Trial advertising
- Subject confidentiality
- IP supply chains, etc.
- Numerous vendors:
- Specialty labs requiring unique kits
- Imaging vendors providing central RECIST reads
- Vendors shipping devices or wearables that must be constantly inventoried
But, as complicated as oncology trials may be, they represent a source of hope for people living with cancer, so it’s important to get them right.
Key inefficiencies in oncology trials and how to solve them.
Patient recruitment
Recently, the number of participants being recruited into oncology trials has fallen. Considering that only about 1 in 20 patients consent to clinical studies in the US, there’s a limited pool of people who can meet the strict inclusion/exclusion criteria of oncology studies.
In studies of rare cancers or pediatric tumors, for example, recruitment can be particularly perplexing, and here again, study delays become inevitable.
Instead of solely relying on the traditional model of using trial sites to recruit subjects, sponsors can now supplement this by using recruitment vendors or software applications. Some of which specialize in specific therapeutic areas, making outreach even more targeted and efficient.
Trial conduct
Executing oncology protocols while ensuring compliance with regulations requires skilled and competent clinical operations teams. Clinops teams are tasked with striking the balance of efficiently executing the trials, while avoiding numerous study deviations, missed milestones, and overall timeline delays.
Typical clinical operations oversight involves repetitive manual workflows and other practices that, without the proper support, can cause the role to become heavily administrative. Traditionally, clinical operations teams are known to use several platforms to access multiple data sources (e.g. IXRS, EDC, CTMS, etc.) to manage their studies, but to date, these have done little to tame complexity or reduce workload.
With the number of data sources increasing, trial oversight is expected to become even more complex. There is need to seek newer, more intuitive solutions to make clinical trial oversight leaner and more efficient. The days of multiple portals, endless trackers, and document vaults should be left behind.
Did the pandemic help to improve trial efficiency?
With the declaration of the COVID-19 pandemic, to accommodate for patient safety, sponsors had to quickly revisit how they were running studies.
Trial investigators had to develop more patient-centered study designs and started employing digital technologies to integrate study elements virtually, since traditional workflows were no longer practical. New technology for virtual collaboration and study conduct, including for patient recruitment and monitoring, were quickly adopted.
These changes have improved convenience for study patients and investigators alike, by allowing for greater flexibility and decentralization.
But there continues to be an urgent need for studies to be done more efficiently to reduce costly errors and timeline delays.
Each day a clinical trial is delayed, a sponsor can lose hundreds of thousands of dollars. This number increases exponentially, into the millions, when the investigational product (IP) being investigated is potentially a blockbuster.
As we move into a post-pandemic era, sponsors are still having to maintain the balance of conducting high quality trials while staying on schedule and within budget.
Innovative technology and experienced staff who can handle complex protocols help maintain this balance. However, in-house technologies that subjugate the efforts of clinical operations teams always threaten to introduce complexity and errors.
To avoid this, clinical operations decision makers should ensure access to more efficient technologies that would:
- Accommodate complex trials, such as for oncology and neurology
- Lower total workload
- Be easy to implement and use
- Simplify or eliminate existing workflows
- Allow easy integration and/or imports of key data sources
- Enable access to updated and accurate reports as needed
- Enable end users to conduct in-depth analyses and visualize trial status at all stages
- Enable informed decisions from useful and visually appealing dashboards and reports
ClinOps Pro is a clinical operations oversight solution that not only helps sponsors eliminate unnecessary workflows, but it also provides bundled services to eliminate repetitive tasks and complement clinical operations teams. ClinOps Pro was designed by clinical operations experts with a passion for eliminating clinical operations inefficiencies altogether.
Sources
- Kaushik, R., & Kaushik, N. (2019). Challenges in Oncology Studies: Review from a Global Perspective. European Journal of Clinical Oncology, 1 (1), 5–7. Retrieved from: https://www.iomcworld.org/articles/challenges-in-oncology-studies-a-global-perspective.pdf
- Araujo DV, Watson GA, Siu LL. The Day After COVID-19—Time to Rethink Oncology Clinical Research. JAMA Oncol. 2021;7(1):23–24. doi:10.1001/jamaoncol.2020.4240. Retrieved from https://jamanetwork.com/journals/jamaoncology/fullarticle/2769924
- Ajithkumar, T. V., & Gilbert, D. C. (2017). Modern challenges of cancer clinical trials. Clinical Oncology, 29 (12), 767–769 Retrieved from: https://www.clinicaloncologyonline.net/article/S0936-6555(17)30440-5/fulltext
- March/April 2022 Tufts CSDD Impact Report (Vol 24; No 2). Cost Variation and Mis-Estimation Characterize Clinical Trial Budgets, Particularly in Early Phases
- https://www.pharmasug.org/proceedings/2011/IB/PharmaSUG-2011-IB03.pdf
