Replacing Study Subjects

Case Studies

Problem:

Figures presented at a recent North Carolina pharmaceutical conference show that 50% of the clinical sites selected to conduct a clinical trial will enroll zero or only one subject. Even with the advent of social media initiatives and other creative new ways to boost recruitment, enrolling an adequate number of subjects in a timely fashion remains a critical issue for the drug development industry. Eligible subjects, in a word, are precious.

Precious, too, are randomization schedules and statistical design. A second wave dilemma comes after an eligible subject is finally enrolled, assigned to the next slot in the randomization schedule, and then turns out to be, for one reason or another, a case of early withdrawal. Not only does this impact the goal of a treatment group’s minimum number of subjects, but –importantly – it impacts the balances and ratios built into the study randomization schedule at study startup.

Drug Hiatus…

Case Studies

Hey, I need a break from the dosing regimen…!
Problem:

Your study has a fairly complex drug titration pattern. In addition to multiple pre-planned titrations, subjects in your clinical trial can go up or down one dose level in the maintenance phase, based on medical assessment. If the subject has an unusual medical event intervene in the ‘dose escalation’ phase – for example, a hospital stay for an unrelated issue – the subject may either need to be discontinued from the trial or somehow be permitted a ‘drug vacation’ after which the system will permit return to a previous dose/visit level or movement to a new level. How to do this with an IRT?
Solution:

Other IRT systems may not allow this flexibility. But Veracity Logic’s IRT includes a ‘drug hiatus’ functionality which permits a subject to maintain their regular visit schedule but take a break from drug assignment. At the end of the hiatus period, its length set by protocol or flexibly determined by medical assessment, subjects return to drug assignment, either at the previous dose level or at a new level.

Protocol Deviations: We need authorization…quick!

Case Studies

Problem:

The study has been suffering from slow enrollment. An excellent candidate, medically speaking, walks into Site 101 but there’s one problem: The minimum enrollment age for the clinical trial is 18. The age of the new potential candidate is 17 years, eight months. The Study Coordinator at the site not only needs a quick decision, but one that protects the integrity of the protocol at the same time. What to do?
Solution:

Veracity Logic’s IRT system provides Authorization Codes for just such occasions. Site users contact designated personnel, such as the primary medical monitor, to obtain a quick field decision from the sponsor for whether the protocol deviation is advisable for the study. Authorization codes are held within the IRT system; available codes are easily accessed by the designated decision makers. A code documenting permission to register the subject is provided to the site user for entry into the IRT database. The fact that a protocol deviation has occurred, and the vital specifics of that deviation, can be easily tracked by the biostatisticians using Veracity Logic’s VLIRT® IRT.

Authorization codes can also be used to manage and document authorized unblinding of subject treatment data, wherever there is an intersection between the need for a speedy decision and the need for care and protection of protocol integrity.

This is just one of the many ways Veracity Logic’s IRT meets real-life scenarios with real-life solutions.

Handling Subject Privacy Issues…

Case Studies

Oh my, not all demographics are created equal…
Problem:

Your clinical trial has hundreds of subjects taking place in 32 countries. One of the best ways to help sites ensure accurate identification across subject visits is to require not only a unique ID for each subject but also a linked Date of Birth (DOB) and three-part subject Initials. Trouble is, some countries allow the capture of DOBs and some regard their presence in the IRT as a violation of patient privacy. Likewise, some countries allow the use of Initials…and some don’t. What to do?
Solution:

Veracity Logic’s IRT was built with the capacity for demographic diversity in mind. By means of simple configuration settings, each site within each country can be set to capture Initials, or to replace Initials with dashes. Likewise, by simple configuration settings, each site within each country can require the collection of either a full DOB or, alternatively, an Age and Year of Birth.

By focusing on configurability rather than time-consuming custom coding, Veracity Logic’s IRT is easily modified to meet a wide variety of real-life study needs. No need to wrestle with systems that require ‘one size fit all’!

Subject Management and Demographics

Newsletter Archive

Handling a World of Diversity

Your clinical trial is global and age- of-subject is a critical variable. For most countries, Date of Birth is collected. But some countries, like Germany, regard the collection of

Date of Birth as a violation of subject privacy. Not only that, your present IRT system requires that three-part initials be entered as a way of confirming subject identity. But some countries regard that as a violation of privacy, too. What to do?
Solution: Demographic Flexibility

Veracity Logic’s IRT system was built to allow demographic flexibility, for these and other subject variables, on a configuration basis within and across studies. In other words, within the same study, Site A can collect Date of Birth while Site B collects only Year of Birth and Age. And it does it as part of the standard system – no time delay for custom coding. Likewise with subject initials – sites easily have the option of entering three initials, two initials, or just hyphens if such identifying information is prohibited. The same configuration option applies to other demographic variables, like height and weight, kg and pounds, BMI, and so on.

This is just one of the many ways Veracity Logic’s IRT meets real-life scenarios with real-life solutions.