Safety and risk management in clinical trials for chronic wounds with tissue regenerative products.

ABSTRACT:

Background

In tissue regenerative trials, investigators operate in the intersection of routine clinical care and research. Often, clinical trials are the only option to introduce innovative treatments to disadvantaged populations in safety-net hospitals (SNHs). It is necessary to maintain a balance between efficient study conduct and patient safety. Social determinants play a role in medication adherence in clinical trials and chronic disease management that may increase risks if not managed correctly.

Objectives

We aimed to assess the safety of patients in tissue regenerative clinical trials while examining underlying causes to develop proactive risk mitigation strategies for high-risk patients.

Design

A single-center, retrospective study was conducted for clinical t

SUBMITTER: Malikova MA 

PROVIDER: S-EPMC12783561 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature