Protocol and Assessment Licensing

The Universal Protocol’s Purpose and Goal

There are currently no FDA-approved medicinal treatments for vitiligo repigmentation. Recent developments in basic and translational research investigations have greatly enhanced our understanding of the etiology of vitiligo disease, opening up new possibilities and opportunities for the development of targeted therapeutics. When it comes to new therapeutics, standardized and validated clinical trials are required to ensure that new agents are tested safely and efficiently.

The Global Vitiligo Foundation (GVF) has created and authorized a universal protocol that can be used to guide future clinical studies in vitiligo to address the need for clinical trial optimization, simplification, and promotion of continued clinical trials in vitiligo. This protocol was developed by a group of clinicians and researchers from around the world who have experience treating vitiligo. A uniform template for eligibility criteria, safety measures, and outcome assessment tools is provided by the Universal Protocol. The consistency of these criteria will create a framework within which trials for safety and efficacy can be easily compared.

This Universal Protocol is primarily intended for phase II and phase III clinical trials sponsored by pharmaceutical companies that are investigating experimental drugs that have already completed a phase I clinical trial. Modifications can be made to support a Phase I or Test of Response Rate trial with less strict efficacy goals and fewer subjects.

About the Protocol 

A defined title, inclusion/exclusion criteria, safety evaluations, disease outcome assessments, and a standardized statistical approach to assess the clinical trial’s results make up the universal protocol. The procedure includes forms, charts, and worksheets to make study visits and assessments easier.

The standardized title can be changed depending on the study design; for nonrandomized, non-blinded, or single-blinded trials, alterations can be made. It is possible to employ multicenter or single-center investigations. The cores can then be tweaked for topical or systemic use. Additional changes can be made to account for aspects unique to the investigational product. The inclusion and exclusion criteria may also be changed if necessary, depending on the investigational product’s specific characteristics.

Patient Safety

The safety of the patients is paramount. As a result, core safety tests should be maintained to the greatest extent possible. To adapt to a certain investigational product, unnecessary testing can be removed. In general, it’s better to err on the side of caution when it comes to patient safety, therefore we’ve included a huge number of tests to consider, which can be amended based on the investigational agent’s potential adverse effects. There should be a set number of safety visits and inspections. If necessary, additional safety visits for certain experimental drugs may be added.

Outcome Assessment 

Measures of outcome assessment take a similar approach. Because vitiligo improves slowly, maintaining a minimum treatment length of 24 weeks and a follow-up term of 12 weeks is a recommended aim. It’s possible to include outcome evaluation tools that are tailored to a particular experimental drug. Novel outcome measures can be examined and validated alongside established outcome measures using new techniques. Future research may use these new outcome measures to supplement or replace existing ones.

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