GTI
Glucocorticoid Toxicity Index

The GTI 2.0 Digital Platform

Scalable, easy to integrate into any trial database. The instrument is efficient, accurate and fast.

Several Phase 3 clinical trials are already using GTI 2.0. Integrate GTI into your trial database so the GTI steroid treatment safety scores can help make your case for efficacy AND safety of your new treatment protocol. Interactive checklists, instructions, data checks, and embedded algorithms ensure reliable data capture and accurate calculation.

The GTI 2.0 streamlines your clinical trial

More than half of the GTI data is completed by the trial coordinator.
Clinical Investigators complete each visit with step-by-step prompts.
The GTI app calculates two scores that capture the nuances of steroid damage over time.
How will the GTI work for my trial?

Whether you’re a clinician, CRO, or study coordinator, we have answers to your concerns.

Cro
Clinician
Coordinator
Is the GTI difficult to use?
Loading data is easy - and quick. Completing the 9 modules can be done all at once or as patient data become available. The GTI app handles all calculations as data are entered and lets you know if you are missing any data. Although the timing of data collection will vary according to the specific trial or study, with the GTI app each patient visit can be recorded in a minute or two.
How long does it take to get scores from the GTI?
GTI scores are in your hands as soon all required data are complete.
What is the cost to my organization to use the GTI?
The GTI requires the purchase of a license. Each license and its fees are tailored to the design and size of the clinical trial. The GTI App saves hundreds of hours of staff time and data calculation.
Why is there no GTI score calculated at the Baseline Visit?
The GTI measures change in glucocorticoid (GC) toxicity. Therefore, a score can be derived only when comparing values from one visit to the next. Data related to GC toxicity are captured at Baseline, but GTI scores are calculated at designated follow-up visits, when GTI data are required by the protocol.
Does the GTI improve the process of studying steroid toxicity?
Yes. The App reinforces rigorous use by prompting both the study coordinator and physician investigator to complete the modules in an intuitive order. The GTI app incorporates the GTI Domains and the Additional Manifestations List logically and thoroughly.
Does the Physician Investigator need to complete all the data at every visit?
No. One of the strengths of the GTI is that more than half of the modules can be completed by the study coordinators. The study coordinators enter all the GTI data pertaining to the subject’s medications, vital signs, routine laboratory work, and bone mineral density study results; in short, five of the GTI’s nine domains.
How do I know that the data I enter is accurate?
The generation of baseline data for most of the GTI Domains is straightforward and data fields protect against inaccurate: 1) The numerical values for medications, labs, vital signs, and bone mineral density are quantitative. 2) The other modules - steroid myopathy, skin, neuropsychiatric, infections, and other toxicities - are semi-quantitative, relying upon an evaluation by the physician-investigator.
What is the protocol for use of the GTI?
The best practice is to share the work, to ensure efficient and accurate data capture. Trial Coordinator or Nurse: Step 1. Updates any changes in the subject’s medications for the treatment of hyperglycemia, hyperlipidemia, and hypertension. Step 2. Weighs the subject, records the subject’s height (at only the first visit), and measures the subject’s vital signs. Step 3. Records the results of laboratory tests that are relevant to the GTI, specifically the hemoglobin A1c (HgbA1c) and low-density lipoprotein (LDL) measurements, as well as the results of bone mineral density studies. Results of these tests may not be available at the time of the Trial Visit but should be completed by the Study Coordinator as the results become available. Step 4. The physician investigator examines the subject, gathering data required for the scoring of the remaining Domains, namely: · Steroid Myopathy · Skin Effects · Neuropsychiatric Impact · Infection · Other Toxicities The data can be captured easily over the course of a routine study visit, requiring only focused history-taking skills and a directed physical examination.
Can data from a previous visit be changed or updated after the visit has been completed?
Yes - with exceptions designed into the coding to maintain integrity of each trial across the calculations and protect the accuracy of the scoring.
How is GTI Score calculated?
GTI data are analyzed in two ways: 1: Cumulative Worsening Score (CWS) For trials in some diseases, it may be most important to document ANY cumulative GC toxicity that occurs. The CWS assesses cumulative toxicity, both permanent and transient, thereby serving as a record of toxicity. 2: Aggregate Improvement Score (AIS) With the AIS, GC toxicities are DELETED if they resolve - leading to an improvement in the score - and are ADDED if they worsen. In a trial anticipating that many patients will have some GC toxicity at baseline , the AIS establishes that the new therapy is effective at reducing baseline toxicity over time.
Which GTI Score do we use for our trial?
Together, the CWS and AIS provide a granular and consistent assessment of GC toxicity in subjects in one treatment arm compared to subjects in another treatment arm. Both scores are useful and together provide a complete picture of steroid toxicity.
Ways To Use The GTI Digital Platform

The GTI is a digital medical application created BY clinical investigators FOR clinical investigators.

SaMD
Description:
The GTI can be integrated into CRO databases for efficient deployment in large, multi-center trials to measure steroid toxicity at scale. The licensing fee is negotiated based on the scope of an individual trial.
Appliance
Description:
The GTI can also be licensed as an appliance to reside on the server of a large CRO. A subscription licensing model is an option when an organization needs access to the software across multiple trials.