Cancer remains a critical health challenge, ranking as the second leading cause of death in the U.S. However, the strides we have made are undeniably remarkable. In the field of oncology clinical trials, a major shift towards biomarker-focused studies and precision medicine has sparked a revolution, leading to improved drug success rates and ultimately enhanced patient outcomes.
While we should celebrate this promising progress, we must also recognize the growing burdens shouldered by patients, caregivers, and trial sites. As we’re trying to get more information out of each study, patients, who are often already very sick, are asked to return to the clinic multiple times for blood draws, tissue collections, and other needs. Sites are also having to deal with increasing complexity of these biomarker-focused trials, while being stuck with manual processes, siloed operations, and outdated technology. Add to that the complex regulatory considerations as well as challenging financial obstacles faced by early-stage oncology trials and it’s not hard to see why systemic change is so critically needed.
This year, Slope, the company I work for, aligned our mission with CancerX, which is a crucial part of the White House’s Cancer Moonshot. As a founding member of CancerX, we are committed to working collaboratively to revolutionize the execution of clinical trials and make significant strides in reducing cancer-related deaths by 50 percent within the next 25 years. Achieving this vision requires the collective efforts of the entire industry, and I firmly believe that there are four key areas where we can initiate meaningful action starting today.
Design Trials with Patient Experience at the Center
A cancer diagnosis adds significant pressure to any individual including but not limited to physical, emotional, social, and financial impacts. Due to the overwhelming impact of the condition, it is very important to keep this in mind. Designing ethical oncology research with optimal study outcomes requires placing patients and their quality of life at the center. A patient-centric trial revolves around three core pillars: fostering collaboration, considering patients’ daily lives, and treating patients as invaluable contributors.
While the primary responsibility for designing a patient-centered clinical trial lies with the sponsoring entity, it should be a collective effort involving all stakeholders. Seeking input from regulatory agencies, CROs, vendors, sites, and most importantly, patients themselves is essential. Only sites and patients truly understand the burdens patients face, making their perspectives crucial.
Remember that patients are active participants, not passive actors. Empower them by providing transparency, support, and sharing relevant data throughout the process. Protect them by ensuring that all data collected is complete and attributable. Treat them as you would treat your internal study teams, recognizing their invaluable contributions.
Furthermore, prioritize patients’ daily quality of life. Assess whether multiple visits to various physicians are necessary and explore integrating study procedures into existing care. Consider patients’ reliance on caregivers for transportation and care support. Minimizing the burden on patients involves including only essential procedures required for data collection.
By adhering to these principles, a patient-centric approach can be adopted, leading to more ethical research, improved outcomes, and enhanced patient experiences.
Choose Technology That Streamlines the Process
The clinical trial landscape is saturated with diverse technology offerings, each solving a specific aspect of the oncology trial process. However, these fragmented solutions often lead to challenges. Sponsors frequently select unfamiliar technologies, creating additional effort for adoption and implementation. Moreover, these specialized technologies contribute to duplication of efforts, data, and the need for time-consuming reconciliation between platforms.
To overcome these challenges, a holistic approach to technology adoption in clinical trials is crucial. Solutions should be chosen with consideration for their impact on all stakeholders, prioritizing user-friendliness, seamless integration, and minimizing duplication. Emphasize the importance of user-friendly technology that seamlessly integrates into existing practices, ensuring minimal disruption and avoiding major adjustments.
By optimizing technology usage, the clinical trial process can achieve efficiency, collaboration, and effectiveness for all parties involved.
Prioritize Collaboration in Navigating Regulatory Complexities
Study design holds significant importance in regulatory considerations, encompassing various complexities such as inclusion criteria, dose-limiting toxicity requirements, and expected endpoints or response criteria. Engaging regulatory agencies like the FDA throughout the program design process, including development plans, is essential to ensure their acceptance of the proposed study plan.
To effectively navigate these complexities, sites should prioritize establishing collaborative relationships with sponsors and actively engage with review boards during the study design phase. Don’t hesitate in providing feedback to sponsors when certain aspects of the study do not align with site processes or prove challenging to execute. Additionally, staying updated on evolving regulatory landscape and guidelines, even if primarily targeted at sponsors, allows sites to have a seat at the table and keep patients informed.
Ultimately, improved communication and collaboration are key. Regulatory agencies, local committees, sponsors, and patients all contribute as partners towards a common goal. By fostering a spirit of cooperation and embracing innovative approaches, we can undoubtedly achieve better trial outcomes.
Plan Ahead to Ease Financial Burdens
Lengthy studies, low response rates, and challenging investment environments are just some of the issues contributing to the financial challenges associated with complex clinical trials. To mitigate these obstacles, clinical trial professionals should prioritize tight upfront planning, data-driven decision-making, process standardization, and compliance.
Effective planning is crucial to optimize study efficiency and obtain necessary approvals. Focus on gathering essential data to demonstrate safety and efficacy, allowing for data-driven go/no-go decisions. Streamline data collection processes, eliminate redundancies, and avoid unnecessary elements. Implement standardized study execution and oversight, utilizing tools that reduce site and patient burden, accelerate startup timelines, promote stakeholder collaboration, and prevent wastage of time, efforts, and resources. Additionally, ensure the ability to generate real-time results and maintain compliance through robust oversight.
As an industry, we have made remarkable strides with cancer research. However, the burdens on patients, caregivers, and trial sites cannot be ignored. To address these challenges, a patient-centric approach is crucial, prioritizing collaboration, considering patients’ daily lives, and valuing their contributions. Streamlining technology adoption, navigating regulatory complexities through collaboration, and proactive financial planning are also key steps to optimize trial efficiency. By embracing these principles, we can drive meaningful change, further improving trial outcomes and ultimately, transforming the lives of cancer patients.
Hope Meely
Hope Meely is the Chief Clinical Officer at Slope, the industry-leading provider of a clinical trial execution platform for highly complex, sample-intensive clinical trials. Hope has spent the entirety of her 20+ year clinical research career supporting several sponsors and CROs in leading clinical operations teams in the execution of their clinical trial programs. Most recently, she spent three years in a growing biotech leading operations for a robust early phase oncology pipeline. She is passionate about making clinical trial operations easier for research sites, sponsors, and other collaborators.
