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Publicly funded clinical trials and the future of cancer care
1Section of Hematology-Oncology, The University of Chicago, Chicago, Illinois, USA. richard.schilsky@asco.org
Abstract:
Publicly sponsored trials, conducted primarily by cooperative groups sponsored by the National Cancer Institute, and commercially sponsored trials are necessary to create new knowledge, improve the care of oncology patients, and develop new drugs and devices. Commercial sponsors launch clinical trials that will result in drug approval, label extension, expansion of market share, and an increase in shareholder value. Conversely, publicly sponsored trials seek to optimize therapy for a particular disease, create new knowledge, and improve public health; these trials can also result in label extension of a drug and even in initial drug approval. Publicly sponsored trials may combine and/or compare drugs developed by different commercial sponsors, develop multimodality therapies (e.g., the combination of chemotherapy and radiation), or develop novel treatment schedules or routes of drug administration (e.g., intraperitoneal chemotherapy). Publicly sponsored trials are more likely to focus on therapies for rare diseases and to study survivorship and quality of life; these areas may not be a priority for commercial entities. Screening and prevention strategies have been developed almost exclusively by the public sector given the large sample size and long follow-up period needed to complete the trial and, therefore, the lack of short-term commercial gain. Finally, given the public nature of the funding, clinical investigators are expected to publish their results even if the outcomes are unfavorable for the investigational therapy. With the ongoing reorganization of the cooperative groups to form a national clinical trials network, opportunities exist to create a robust platform for biomarker discovery and validation through the expanded collection of well-annotated biospecimens obtained from clinical trial participants. Thus, publicly funded trials are vital to developing and refining new cancer treatments and disseminating results to the medical community and the general public.
Insights
Publicly and commercially sponsored clinical trials advance cancer care and drug development. Publicly funded trials uniquely focus on rare diseases, survivorship, and prevention, ensuring broader public health benefits.
Area of Science:
- Oncology
- Clinical Trials
- Public Health
Background:
- Both publicly and commercially sponsored clinical trials are essential for advancing cancer care, developing new drugs, and improving patient outcomes.
- Commercial trials prioritize drug approval, market expansion, and shareholder value.
- Publicly sponsored trials aim to optimize therapies, generate new knowledge, and enhance public health, often focusing on rare diseases and survivorship.
Discussion:
- Publicly funded trials explore novel treatment combinations, schedules, and administration routes, including multimodality therapies.
- Screening and prevention strategies are predominantly developed through public sector initiatives due to long-term study requirements and limited commercial gain.
- Public funding necessitates the publication of trial results, regardless of outcome, ensuring knowledge dissemination.
Key Insights:
- Publicly sponsored trials are critical for investigating rare disease treatments, survivorship, and quality of life, areas often overlooked by commercial sponsors.
- The public nature of these trials ensures transparency and the dissemination of all findings, fostering medical community and public understanding.
- Public trials facilitate the development of screening and prevention strategies, crucial for long-term public health impact.
Outlook:
- The reorganization into a national clinical trials network presents opportunities for enhanced biomarker discovery and validation.
- Integration of biospecimen collection within clinical trials will strengthen research capabilities.
- Continued public investment in clinical trials is vital for refining cancer treatments and improving patient care globally.
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