Optimizing Oncology Trial Design and Execution
Only 3-5% of adult cancer patients in the U.S. and fewer than 1 in 20 globally participate in clinical trials, largely due to stringent eligibility criteria.1 This low enrollment highlights the complexities of oncology trials with multifaceted treatments and ethical considerations, emphasizing the need for effective patient recruitment and retention strategies. Geographical barriers, stringent criteria, and patient hesitancy pose significant challenges.
Biopharma companies seek solutions through unified platforms with automated software to enhance patient engagement, participation, and inclusion of underrepresented communities. Overcoming operational inefficiencies and high costs associated with managing dispersed patient populations is crucial. Tailored approaches are vital to address the unique demands of cancer clinical trials, characterized by intricate regimens, ethical considerations, and the paramount importance of patient recruitment and retention.
Understanding Contrasts: Cancer Clinical Trials in Focus Cycles of Treatment
Cancer trials often involve non-linear, personalized treatment regimens combining surgery, radiation, chemotherapy, targeted therapies, biomarker-driven approaches, and combination drugs.
Oncology trials now include biomarker stratification and the usage of combination therapies. A preliminary study showed an overall response rate of 85% with an 11% complete response rate, and there was an acceptable tolerance of combination cancer therapies.2
These complex, patient-specific protocols require meticulous monitoring and adjustments based on individual responses. The increasing complexity necessitates clinical trial management platforms to streamline clinical research, protect data integrity by reducing data errors, ensure quality data collection, and ease trial operations.
1. Novel Treatment Modalities
The global cancer gene therapy market accounted for $2.95B in 2023 and is projected to reach around $18.11B by 2033, growing at a CAGR of 19.9% from 2024 to 2033. The U.S. cancer gene therapy market alone was valued at $1.25B in 2023 and is anticipated to reach around $7.94B by 2033, with a CAGR of 20.31% from 2024 to 2033.3 This underscores the shift towards gene therapies for cancer and novel treatment modalities.
Jeeva partnered with ImmunoACT, which makes cell and gene therapies accessible in India. This collaboration focused on streamlining clinical development for ImmunoACT's leukemia and lymphoma treatments. By potentially implementing adaptations like streamlined clinical research processes under one login, we were able to drive down costs by 90%, making these potentially life-saving therapies accessible to patients at 10% of the cost compared to existing therapies.
2. Patient Engagement and Retention
Cancer clinical trials often require long-term follow-up to assess overall survival and progression-free survival adequately. The average dropout rate in oncology trials is around 20%, with patient fatigue and loss of follow-up being major contributors. Keeping patients engaged and ensuring their retention throughout the trial is a significant challenge. Platforms like Jeeva support patients in over 100 languages, providing global access and enabling participation from diverse, non-native English speakers (a crucial factor given that 60% of cancer cases occur in Asia, Africa, and Central/South America).
3. Duration Comparison
Oncology trials tend to have a longer median duration compared to trials in other therapeutic areas, lasting around 12 years.4 However, it's worth noting that rare disease studies may also involve extended timelines due to the challenges in patient recruitment and the need for long-term follow-up.
4. Regulatory Scrutiny and ASHA FDA
The US and India launched Project Asha, a collaborative effort to address the limited access to cancer clinical trials in India (only 1.5% globally despite a 20% population share).5 Project Asha targets two key areas:
- Empowering Early Researchers: It provides training for early career researchers in India to design and conduct pragmatic, patient-centered clinical trials.
- Fostering Inclusive Research: Project Asha seeks to identify collaborative opportunities that promote more inclusive and equitable participation in international cancer research and clinical trials. This includes establishing mechanisms for cross-border data transfer, aiming to maximize scientific cooperation while upholding the strictest patient privacy protections.
5. Project Asha
Project Asha aims to improve cancer care and outcomes for Indian patients by building research capacity and fostering international collaboration. It also works closely with Indian regulatory authorities and the government to increase access to oncology trials and share initiatives to improve global cancer care.
6. Complexities of Advanced/Metastatic Patient Populations
Cancer trials often involve patients with advanced or metastatic disease, presenting unique needs and challenges compared to other trials. The SOLAR-1 trial for metastatic breast cancer required careful management of co-morbidities and prior treatment histories in patients with advanced stages.6
7. Data Collection
Collecting data from such populations necessitates integrating multiple report types, including EHRs for co-morbidities and prior treatments, imaging reports for disease monitoring, and patient-reported outcomes (ePROs) for quality-of-life assessment. Advanced clinical trial platforms can streamline this integration, enabling comprehensive evaluation of safety and efficacy for complex patient populations through unified analysis of multiple data reports.
8. Endpoint Measurement and eCOA
Measuring endpoints like overall survival and progression-free survival in cancer trials is complex and lengthy. Oncology trials typically last two to three times longer than other therapeutic areas. Accurate endpoint capture is crucial, often utilizing electronic clinical outcome assessments (eCOA) to collect patient-reported outcomes.
eCOA platforms facilitate remote data capture, reducing patient burden and ensuring data integrity and regulatory compliance, making them essential for long-term monitoring in oncology trials.
These differences highlight the unique challenges and intricacies of conducting oncology trials, necessitating specialized approaches to design, execution, and regulatory compliance.
1. Challenges in Patient Recruitment and Retention For Oncology Trials
Oncology clinical trials face numerous challenges in patient recruitment and retention, impacting the overall success and timelines of these trials.
2. Strict Eligibility Criteria
Oncology trials often have stringent eligibility requirements, limiting the pool of potential participants. These criteria are necessary to ensure patient safety and obtain reliable data but can exclude many patients who might otherwise benefit from the trial. Eligibility often involves lab tests, invasive procedures, and frequent hospital visits, further narrowing participant availability. Studies show that 27% of oncology trials fail to meet their enrollment targets due to strict eligibility criteria.7
3. Geographical Barriers
Many patients live far from trial sites, making regular visits challenging. This geographic dispersion of patients can significantly hinder their ability to participate in and adhere to clinical trials. According to the Tufts Center for the Study of Drug Development, 40% of potential clinical trial participants live more than two hours away from the nearest trial site. Often, rural patients are underrepresented in clinical trials due to the distances involved in traveling to urban trial centers.
4. Fear and Misinformation
Patients may be hesitant to participate in clinical trials due to fears about experimental treatments and a lack of understanding about the trial process. Misinformation can lead to distrust and reluctance to join trials.
Building trust through clear communication and using the patient's native language is crucial. Jeeva, for instance, provides patient support in over 100 languages to enhance understanding and trust in patients' native language(s). The Center for Information and Study on Clinical Research Participation (CISCRP) found that 37% of patients cited fear of side effects as a major barrier to clinical trial participation.8
Beyond Borders, Better Results: Biopharma Companies Addressing Operational Inefficiencies
Addressing operational inefficiencies and high costs in geographically dispersed oncology trials, while enhancing patient engagement among underrepresented communities, requires a multifaceted approach. These include:
1. Traditional, Hybrid, and Decentralized Clinical Trials (DCTs)
Traditional trials require patients to visit clinical sites, but hybrid and decentralized approaches leverage technology to conduct parts or all of a trial remotely. By combining in-person and remote elements, these trials reduce the need for patients to travel, lowering logistical costs and broadening access. Participants can engage in remote monitoring, telehealth consultations, and educational sessions, breaking barriers and ensuring better results: fewer hospital readmissions, better health outcomes, and higher patient satisfaction.9
2. Artificial Intelligence for Streamlining Clinical Research and Patient Enrollment Workflows
AI can analyze vast datasets to identify suitable trial participants quickly, ensuring a more diverse and representative sample. It also helps in predicting patient outcomes and optimizing trial design. Clinical research management platforms harness the power of AI to improve patient recruitment and retention by making clinical trials accessible on a global scale, saving time by avoiding manual repetitive tasks, and ensuring a more diverse representative sample.
3. Patient Engagement Strategies
Digital platforms that provide patients with trial information, reminders, and easy communication with the research team can enhance engagement and adherence to trial protocols. The Jeeva eClinical Cloud platform improves patient engagement by providing easy access to trial information and enabling remote participation. Jeeva’s patient platform is available in 100+ languages, ensuring non-English speakers have access to clinical trials, thereby increasing patient recruitment rates and boosting clinical research.
By implementing these strategies, biopharma companies and clinical researchers can address operational inefficiencies and high costs associated with geographically dispersed oncology trials while enhancing patient engagement and participation, particularly among underrepresented communities.
Streamlining Access: Unified Platform Approach With Workflow Automation for Diverse Participation in Oncology Trials
With the industry push, regulatory frameworks for globally inclusive clinical trials in oncology underscore the importance of unified platforms that streamline clinical trials and enhance patient engagement. Unified platforms with automated software suites enhance patient engagement and participation in oncology trials, especially among underrepresented communities, by addressing various barriers and streamlining the entire trial process.
1. Simplified Enrollment Processes
Unified platforms streamline the enrollment process by automating eligibility screening and consent forms. This reduces the complexity and time required for patients to join trials, making it easier for underrepresented populations to participate.
2. Jeeva eClinical Cloud
Jeeva eClinical Cloud offers an automated enrollment system that simplifies the patient onboarding process, increasing participation rates from diverse demographics.10
3. Enhanced Communication Channels
Automated software suites provide multiple communication channels (e.g., SMS, email, mobile apps) to keep patients informed and engaged. These channels are crucial for maintaining regular contact with patients and ensuring they stay informed about trial updates.
4. Remote Monitoring and Telemedicine
Telemedicine capabilities allow patients to participate in trials from the comfort of their homes. This is particularly beneficial for those in rural or underserved areas who might otherwise be unable to participate due to travel constraints.
5. Language and Cultural Competence
Unified platforms offer materials and interfaces in multiple languages and culturally adapted formats, making them more accessible to non-English-speaking populations and culturally diverse groups.
6. Data Security and Privacy
Secure technologies ensure the confidentiality and integrity of patient data, which can increase trust among participants, particularly in underrepresented communities that may have concerns about data privacy.
7. Personalized Patient Support
Automated systems can offer personalized support and follow-up, such as reminders for appointments and medication adherence. This level of support helps keep patients engaged and reduces dropout rates.
8. Real-Time Data Access
These platforms enable real-time access to trial data for both patients and researchers, facilitating an easy bidirectional conversation and immediate feedback and adjustments. This transparency can enhance patient trust and engagement.
9. Community Partnerships and Outreach
Automated platforms facilitate partnerships with local community organizations to improve outreach and engagement efforts. These partnerships are vital for building trust and increasing participation among underrepresented communities.
Conclusion
Oncology trials face unique complexities, challenging patient recruitment and retention. Innovative solutions like unified platforms with automated features can streamline operations, enhance engagement, and address equity issues. Coupled with patient-centric approaches and technological advancements, these solutions have the potential to accelerate progress in developing life-saving cancer treatments for all populations.
References
- Unger JM, Cook E, Tai E, Bleyer A. The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. American Society of Clinical Oncology Educational Book [Internet]. 2016;36:185–98. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC5495113/
- Fisusi FA, Akala EO. Drug Combinations in Breast Cancer Therapy. Pharmaceutical Nanotechnology. 2019 Jan 22;07.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691849/
- Cancer Gene Therapy Industry is Rising Rapidly Up to USD 18.11 Bn by 2033 [Internet]. BioSpace. [cited 2024 Jun 12]. Available from: https://www.biospace.com/article/releases/ cancer-gene-therapy-industry-is-rising-rapidly-up-to-USD-18-11-bn-by-2033/
- Oncology Trials Outpacing Rest of the Field in Complexity and Duration, Study Shows [Internet]. www.centerwatch.com. Available from: https://www.centerwatch.com/ articles/25599-oncology-trials-outpacing-rest-of-the-field-in-complexity-and-duration study-shows
- Commissioner O of the. Project Asha. FDA [Internet]. 2024 [cited 2024 Jun 12]; Available from: https://www.fda.gov/about-fda/oncology-center-excellence/project-asha
- André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, et al. Alpelisib for PIK3CA Mutated, Hormone Receptor-Positive Advanced Breast Cancer. New England Journal of Medicine. 2019 May 16;380(20):1929–40. https://www.nejm.org/doi/full/10.1056/ NEJMoa1813904
- Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemporary Clinical Trials Communications. 2018 Sep;11(11):156–64. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/
- Dias AL, Chao JH, Lee D, Wu Y, Kloecker GH. Patient perceptions concerning clinical trials in oncology patients. Contemporary Clinical Trials Communications. 2016 Dec;4:179–85. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935901/
- Creber RM, Dodson JA, Bidwell JT, Breathett K, Lyles CR, Still CH, et al. Telehealth and Health Equity in Older Adults With Heart Failure: A Scientific Statement From the American Heart Association. Circulation-cardiovascular Quality and Outcomes. 2023 Nov 1;16(11). https:// www.ahajournals.org/doi/10.1161/HCQ.0000000000000123#d1e1584
- #1 Clinical Trial Research Management Software Solution | SaaS Platform [Internet]. Jeeva Clinical Trials Platform and Services. Available from: https://jeevatrials.com/
Author Details
Harsha K Rajasimha, PhD Founder and CEO- Jeeva Clinical Trials
Harsha K Rajasimha, PhD, is the Founder and CEO of Jeeva Clinical Trials (https://jeevatrials.com), a venture-backed startup with the mission to revolutionize clinical trials, dramatically improve efficiency and universal accessibility with unified software with digital clinical research capabilities for biopharmaceutical and medical device sponsors. Harsha is a fierce advocate for patient-focused drug development for rare and common diseases including oncology. He chairs the annual Indo-US bridging RARE Summit (https://summit.indousrare.org to bring key stakeholders together to address grand challenges.
Publication Details
This article appeared in Pharmaceutical Outsourcing: Vol. 25, No. 3 July/Aug/Sept 2024Pages: 28-31