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CLINICAL TRIALS Patients as Partners in the Modern Clinical Trial Landscape

By: Christine E. Lentowski, MS, MBA, UroGen Pharma, Princeton, New Jersey | Posted on: 25 Oct 2023

The modern clinical trial landscape reflects innovative study designs, technological advancements, and regulatory updates. Of paramount importance, however, is the evolution of viewing patients as partners with regulators and industry in the development of new treatments and the conduct of clinical trials.

The Food and Drug Administration engages in patient-focused drug development meetings to better understand the unmet needs of patients regarding clinical research. Other forums have also been established to give patients and caregivers opportunities to partner with regulators such as patient listening sessions and the Patient Engagement Collaborative.1

Given the value of patients as partners, UroGen Pharma has implemented several approaches to make clinical trials more patient focused.2–4 These include eConsent to enable a more convenient and robust informed consent process, a hybrid study design featuring patient treatment in the home,5 new technology to capture patient-reported outcomes, and support for patient travel to clinical trial sites.

Patients have more options to explore clinical trials, and industry continues to find ways to incorporate the patient voice into clinical trials. The Bladder Cancer Advocacy Network has committed to connecting patients and caregivers with new clinical trial options6 and information about new treatments.7 Partnership between patients and patient advocacy groups, regulators, and industry has generated a more patient-focused clinical trial landscape.

  1. U.S. Food and Drug Administration. FDA Patient Engagement Overview. 2020. https://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-engagement-overview
  2. Seltzer E. A phase 2b study of UGN-102 for low grade intermediate risk non-muscle-invasive bladder cancer (OPTIMA II). 2022. https://clinicaltrials.gov/study/NCT03558503
  3. Prasad S. A phase 3 study of UGN-102 for low grade intermediate risk non-muscle invasive bladder cancer (ATLAS). 2023. https://clinicaltrials.gov/study/NCT04688931
  4. Prasad S. A phase 3 single-arm study of UGN-102 for treatment of low grade intermediate risk non-muscle-invasive bladder cancer (ENVISION). 2023. https://clinicaltrials.gov/study/NCT05243550
  5. Raju S. Feasibility of home instillation of UGN-102 for treatment of low-grade (LG) non-muscle-invasive bladder cancer (NMIBC). 2022. ClinicalTrials.gov Identifier: https://clinicaltrials.gov/study/NCT05136898
  6. Bladder Cancer Advocacy Network. Clinical Trials. 2023. https://bcan.org/clinicaltrials/
  7. Bladder Cancer Advocacy Network. Bladder Cancer Expert Videos. 2023. https://bcan.org/find-support/bladder-cancer-expert-videos-2/

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