Just Say No to One-Kit Shipments

Case Studies

The Challenge:

Striking a balance between effective study drug inventory control and efficient management of shipping costs is not always easy when faced with the real-life complexities of clinical trials.

Automated predictive resupply algorithms that help reduce drug waste at clinical sites are now the order of the day for most IRT (IWR/IVR) systems, albeit with varying degrees of effectiveness when it comes to optimizing shipment efficiencies. Even ‘static’ algorithms – e.g., setting a baseline resupply requirement in the system and using alert levels to dictate when to trigger a new shipment—can present complexities with regard to good shipment management.

Putting Drug Where It’s Needed Most

Case Studies

The Challenge:

Industry statistics indicate that 50% of the sites initiated for a clinical trial enroll 0-1 subjects; with 25% enrolling none at all. With numbers like these, decisions on where and how to distribute precious and expensive study drug become a serious matter for senior management and project teams.

Sites Are Not Created Equal

Case Studies

Problem:

Why try to push a square peg into a round hole? It’s an old saw, but a true one: investigator Sites in clinical trials are widely different in their procedures, their facilities, their local challenges, their staff, their suppliers, their idiosyncrasies. How then does a Project Manager (PM) standardize important aspects of the trial — things like shipping and resupply processes, predictive algorithms, drug sourcing, and more?

Protecting the Study Blind in IRT Processing

Case Studies, IRT Essentials

In recent years there has been an upsurge in professional vigilance with regard to maintaining the study blind in clinical trials. Concern about incidental unblinding — i.e., an unblinding or ‘partial unblinding’ that occurs accidentally in the course of modifying some other aspect of a trial– has grown in proportion to new strategies and techniques adopted by the industry. These concerns apply to all sectors of a study strategy, including outsourced players like IRT (IWR/IVR) systems. Veracity Logic founder Steve Zimmerman led a panel of colleagues in discussion of this subject at the CBI IRT conference in Philadelphia in 2015.

Five IRT Assists for Clinical Project Managers

Case Studies

Challenge:

You’re a Clinical Project Manager (CPM) given a study halfway through enrollment and you need to get up to speed on study status FAST! How can your IRT help?

Solution:

Fortunately, you’re using Veracity Logic’s Interactive Response Technology system, VLIRT®. Here are five key features geared toward CPMs who find themselves in just this predicament.

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.

Getting Data Sooner with IRT Part 2

Case Studies

The Challenge:

In a recent post (see hot topic “Getting Data Sooner”) we talked about how using a ‘give some, get some’ strategy in an IRT system contributes to getting your clinical trial data faster. Users are motivated to enter data in a timely fashion because use of the IRT is required for the site to get critical information required for study conduct and subject treatment — for example, their next kit number, or a dosing calculation. Visit data must be entered before the visit can be accomplished…as distinguished from an EDC system where data entry by the site can lag considerably behind.

But what about data that you want to capture in the IRT which doesn’t fit the ‘give some, get some’ strategy? For example, screen failure, early withdrawals, or receipt of drug shipments. For these kinds of data there is nothing the user requires from the system that would force them to do timely entry.

The Solution:

For instances like these, Veracity Logic’s VLIRT® system provides motivation by appealing to basic principles of human psychology… and by manipulating visit/response windows.

For example: When a subject fails screening, the subject obviously does not show up for their next visit. VLIRT® tracks visit status on the main Subjects page (the landing page for most studies) and turns the name and date of the next scheduled activity bright red once the timeframe for that activity has lapsed. Site personnel, our years of experience attest, don’t like to see red — they know their CRA will also “see red” and will be soon demanding to know what’s happening with the subject in question! Users are thus motivated to eliminate this warning color from their table views by entering the necessary screen fail activity.

The same applies to receiving shipments. Acknowledging receipt is a key factor in keeping site drug inventories accurate and up to date within the IRT. The system can assist by turning red the Sent Date of any shipment that was sent more than X days previously and has not yet been modified to a status of Received.

When selecting an IRT, Program Managers should give careful thought to the application of creative designs that can help solve some of these common problems of clinical trials.

Getting Data Sooner With IRT

Case Studies

The Challenge:

A classic problem in the conduct of a clinical trial is how to motivate site personnel to enter their clinical data in a timely fashion. What can be done to enable project personnel to receive study data sooner?

Push vs. Pull — Tips on IRT Data Integrations

Case Studies

The Challenge:

Your EDC system will house the bulk of your clinical data for the upcoming clinical trial but you’re using an IRT for screening, randomization, and drug assignment. What’s the most efficient, cost-effective way to accomplish two key study goals: to integrate certain data as needed (in a timely fashion), and to avoid time-wasting duplication and reconciliation requirements between systems?