A significant majority—approximately 85 percent—of cancer patients are treated in a community setting, yet only 3 percent of patients are enrolled in clinical trials, which may be partially due to barriers faced by researchers in conducting clinical research in the community setting. A Working Group was created by the ASCO Community Research Forum to look at issues related to research contract and budget negotiations and to identify possible strategies and solutions to help improve efficiencies and minimize burdens faced by community researchers in this area. On May 3, the Working Group released their findings and recommendations in an article published in the Journal of Oncology Practice (JOP).
According to the article, out of 150 survey respondents, 77% felt that barriers existed within the contract negotiation process with clinical trial sponsors. Respondents identified several key impediments by sponsors in these processes, including underestimation of costs, lack of flexibility with contract language, excessive delays, and inefficiencies within the process.
The following recommendations were made to help break down these barriers and make the contract negotiation process easier and more efficient:
- Standardize contract and budget negotiation processes across trial sponsors and contract research organizations
- Improve processes to minimize administrative burden
- Increase use of contract templates across sponsors and promote use of existing resources
- Develop resources on best practices and tips for contract and budget negotiations
- Increase research site training and education on these processes
- Create a forum for research sites to share issues and strategies
- Provide professional consultation services to assist sites with contracts
According to the Working Group, implementing these recommendations and changes through collaboration between researchers, sponsors, and other stakeholders would “help facilitate participation in research and ensure that patients have access to clinical trials.”
The contract and budget negotiation process was also a key focus of the recent ASCO-AACI Best Practices in Cancer Clinical Trials Workshop, held in March at ASCO headquarters in Alexandria, VA to develop solutions to reduce administrative and regulatory burdens and improve efficiencies in clinical trials.