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FROM THE CHIEF EXECUTIVE OFFICER Clinical Trials Collective

By: Michael T. Sheppard, CPA, CAE, CEO, American Urological Association | Posted on: 17 Jul 2024

Clinical trials are crucial in developing and validating new medical treatments and preventions. They provide valuable insights that guide treatment decisions and improve patient care and health outcomes. Yet, these trials can face myriad challenges, including cost and time, participant recruitment barriers, ethical concerns, regulatory hurdles, data management and integrity, placebo effect and blinding, patient burden, and translational challenges.

The AUA is committed to working with our partners and the urologic community to find efficient and impactful ways of improving the clinical trial process from beginning to end, expediting discovery, and enhancing the lives of our patients.

With our Clinical Trials Collective (AUACTC), the AUA is convening a group of stakeholders in the clinical trials space to address and overcome these drawbacks. Stakeholders include a collaborative group of clinical trial expert physicians under the leadership of Chair Dr Yair Lotan, as well as industry partners AstraZeneca, Johnson & Johnson, Innovative Medicine, Novartis, and Olympus. The AUACTC will focus on 4 challenges in particular: resource constraints, a lack of clinical trial navigators, physician unawareness of clinical trials, and reaching underrepresented patients in rural communities.

  1. Resource Constraints: The group will discuss resource constraints faced by clinical trial sites, including financial and personnel resources. They will identify strategies to overcome these challenges and ensure adequate resources are available for conducting clinical trials.
  2. Clinical Trial Navigators: The group will address the lack of clinical trial navigators who can guide patients through the clinical trial process. They will explore the feasibility of developing clinical trial navigator training programs to ensure patients can access the support they need.
  3. Physician Awareness: The group will address the lack of physician awareness of clinical trials, including identifying strategies to improve physician education and awareness of clinical trials for referrals.
  4. Underrepresented Patients: The group will discuss the challenges underrepresented patients face in rural communities and identify strategies to increase their participation in clinical trials.

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Figure. Cover of the October 2023 AUANews Clinical Trials Focus Issue.

In 2024, the AUACTC will establish a collaborative and concerted effort to develop a strategic plan for the years ahead. We have already completed virtual interviews with key stakeholders and a focus group of industry partners and physicians during the AUA Annual Meeting in May 2024. These information-gathering sessions have helped us identify the main roadblocks and areas of opportunity within the 4 focus areas, providing us with a roadmap as we work toward developing the strategic plan.

The AUA can make a particular impact in awareness and engagement in clinical trials. We believe that we can elevate the awareness, understanding, and discussion around clinical trials in urology and place this important conversation at the heart of our community, reaching urologists, the entire health care team, and patients. Using the AUANews print and digital ecosystem, we can reach physicians (and therefore, patients) around the globe.

In fact, read through the Clinical Trials Focus Issue from October 2023, which showcased leaders in the clinical trials space and articles on opportunities and threats in the clinical trial landscape, challenges in staffing trials along with proposed solutions, engaging the practicing urologist in clinical trial efforts, and the perspective of industry partners as well.

The AUA knows clinical trials are the cornerstone of modern medical research and health care innovation. Through the AUACTC and our general outreach efforts, we remain dedicated to improving the efficacy and impact of clinical trials and raising awareness of their existence to help our patients make informed decisions about their treatment and care options.

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