Oncology clinical trials are indispensable in moving new cancer treatments from the laboratory to everyday patient care. There are numerous ways in which oncology trials advance innovation in cancer interventions. Continue reading as we highlight five ways clinical trials make an impact, including the effectiveness and efficiency of clinical research, successful patient engagement strategies, contribution to social value, pharmacovigilance to improve drug safety, and research collaborations to tackle oncology research challenges.
By Tamanna Bhardwaj
What are Oncology Clinical Trials
Clinical trials are vital in moving new cancer treatments from the lab through the different phases of clinical research and eventually to everyday patient care. Oncology clinical trials evaluate the safety and effectiveness of new interventions, including new medications, treatment combinations, surgery or radiation therapy approaches, or methods, e.g., gene therapy and precision oncology. Diverse patient populations from various cancer types and stages enroll in oncology trials, adhering to study protocols that document treatment outcomes and potential adverse effects (AEs).
The rising global cancer burden underlines the pivotal role of oncology clinical trials in discovering interventions to address the unmet medical needs of patients with cancer. In addition, findings from oncology clinical trials help steer cancer care toward more effective and personalized solutions.
Value of Oncology Clinical Trials
Clinical trials are essential as they contribute to the knowledge of advancing cancer medications, answer critical scientific questions, and suggest future research directions. Patients who participate in trials can access high-quality cancer care and treatment(s). In contrast to when clinical trials were seen as a last resort, patients today increasingly choose to participate in clinical trials to receive their first treatment.
Global Oncology Clinical Trial Market
Oncology CROs (Contract Research Organizations) play a fundamental role in developing cancer treatments. The extensive involvement of CROs can span from the initial stages of research to the complex and rigorous final stages of oncology clinical trials. To address the significant global disease burden of cancer, the pharmaceutical industry prioritizes and invests in oncology drug development efforts, which creates a valuable opportunity for sponsors to partner with oncology CROs. Consequently, the global oncology clinical trials market is thriving and has a promising outlook for leading oncology CROs that are newly emerging.
The global oncology clinical trial market reached US$12.98 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 5.30% to surpass US$21.65 billion by 2033. The U.S. oncology clinical trial market, valued at US$3.82 billion in 2023, is expected to grow at a CAGR of 5.50% to reach US$6.49 billion in 2033. By the study phase, the Phase I segment had the highest market share (32%) in 2023 and increased emphasis on biomarker-driven approaches, personalized medicine, and exploring innovative drug combinations.
How Oncology Clinical Trials Advance Cancer Medication
Oncology clinical research leading to therapeutic breakthroughs is vital in improving patient outcomes. Evidence indicates a dramatic rise in survival rates of patients receiving chemotherapy due to the discovery of more effective chemotherapy agents and radiotherapy due to significant advancements in technology. The expansion of oncology clinical trials is facilitated by a supportive regulatory environment with streamlined approval processes and reduced bureaucratic hurdles without compromising patient safety. In addition, growing R&D investment by pharmaceutical companies, biotech firms, and government entities helps drive oncology clinical trials.
1. Tech Advancements Impact Effectiveness & Efficiency of Oncology Trials
Technology advancements, including advanced diagnostic tools and data analysis, refine the precision of patient categorization and biomarker identification while enabling real-time monitoring of treatment responses. Examples include:
The application of artificial intelligence (AI) approaches to extract quantitative information from digital histopathology images for gynecological cancers and deep learning (DL) models show promising results in accurately diagnosing, classifying, and predicting treatment response and prognosis.
DL workflow predicts upper tract urothelial carcinoma (UTUC) protein-based subtypes associated with targetable alterations directly from routine histopathological H&E (hematoxylin and eosin) slides.
Use of AI to enhance global trial recruitment and operations, reach underrepresented populations, lower costs, and accelerate commercialization.
2. Patient-centric Trials & Successful Patient Engagement Strategies
With patient engagement becoming increasingly important in clinical trials, CROs are committed to utilizing the newest tech solutions to support the oncology community, sponsors, and physicians in making the right decisions and supporting a truly patient-centric approach to research. By prioritizing the patient experience, integrating patient-reported outcomes (PROs), and leveraging digital health technologies for remote monitoring, patient-centric trials create significant opportunities for innovation and efficiency:
The benefits of active patient involvement include improved recruitment strategies and patient experiences, potentially higher adherence to trial interventions, and more patient-centered trial outcomes.
PROs in oncology trials reflect the impact of cancer therapies from the patient's perspective. They can inform evaluations with evidence that cannot be obtained or deduced from reports or other biomedical measures. PROs can also support non-clinicians, e.g., administrators, policymakers, health technology assessors, and regulators when considering the cost-effectiveness of new interventions.
Impact on quality of life—Integrating clinical research into patient care can help patients with metastatic colorectal cancer benefit from treatments by first gaining a comprehensive understanding of patient experience and treatment outcomes through PROs.
3. Oncology Clinical Trials & Social Value
Oncology clinical trials and drug development contribute to social value.
An analysis of pediatric oncology trials revealed that a large proportion of Phase I trials informed further assessment and development of tested interventions.
Separately, a recent National Cancer Institute (NCI) analysis found that despite their focus on safety, Phase I trials of new cancer treatments have more potential for clinical benefit than commonly believed. Researchers attributed this to development of modern cancer drugs, such as targeted therapies, immunotherapies, and new combination therapies.
Beyond advancing oncology research, clinical trials enhance cancer awareness and patient education.
4. Pharmacovigilance to Improve Drug Safety
Researchers find that the development of pharmacovigilance (PV) and cancer research continues growing and that the complexity of cancer and its treatment makes PV critical in oncology. Acquiring relevant clinical safety data is essential to advance cancer medications. Examples include:
A study on drug safety in pediatric and young adult patients with hemato-oncological diseases demonstrated pro-active PV's importance in highlighting adverse drug reactions (ADRs) and improving drug safety.
An active PV model for oral anti-cancer drugs was found to play an essential role in the early detection and improved management of AEs.
The implementation of a post-marketing PV system, which first required the complex transition from clinical to the post-approval phase, provided a TFS Healthscience sponsor with complete oversight of its product’s safety profile and supported the U.S. and European Union (E.U.) approval of the sponsor’s very first product.
5. Collaborations to Tackle Research Challenges
Collaborations to advance cancer research take place at different levels, including collaborative efforts between industry and regulatory agencies to streamline processes and expedite the translation of promising interventions from research to clinical practice. Additionally, the NCI orchestrates programs and initiatives to support the research community's progress in cancer research.
Researchers also highlight the role of super collaborations with multiple international groups, each bringing their unique expertise to maximize knowledge synthesis and advance innovations in cancer treatment.
The Cancer Research UK (CRUK)-NCI Cancer Grand Challenges initiative works with the global research community and people affected by cancer to help identify the most complex problems affecting cancer research. The final list of challenges is posed to the research community.
The Cancer Moonshot initiative, which started in 2016, was renewed by President Biden in 2022. Its ambitious objective is to reduce the cancer death rate by a minimum of 50% over 25 years. In its first four years, the Cancer Moonshot initiative resulted in 49 clinical trials and more than 30 patent fillings.
Conclusion
Oncology clinical trials are indispensable in advancing new cancer medications from the lab to everyday patient care. The rising global cancer burden underlines the pivotal role of oncology clinical trials in continuously advancing cancer treatment to address the unmet medical needs of cancer patients. In addition, findings from oncology clinical trials help steer cancer care toward more effective and personalized solutions and recommend future research directions.
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