Do You Need a Secondary IRT Vendor?

IRT Essentials

The Challenge:

The unpredictability of clinical trial scheduling and timelines is a ‘given’ in the world of pharmaceuticals. Seasoned professionals have learned the hard way that one’s chosen vendor in any given domain may not be sufficient to handle whatever comes along — in particular, the tendency of multiple studies, originally scheduled to begin at nicely manageable intervals, to suddenly bunch up in the same month or quarter. In addition, variations in study needs, size, and rules of conduct makes it hard to find a ‘one size fits all’ strategy. At the same time, establishing standard processes and patterns with a given vendor of choice has long been recognized as the most cost-effective and efficient approach to maintain consistency across trials. What to do?

The Solution:

Discussions at recent conferences of clinical trial professionals make clear that an increasing number of Sponsors and CROs of all sizes are overtly pursuing a dual-vendor strategy when it comes to key services like Interactive Response Technologies (IRT). Selection of a secondary (and in some cases, tertiary!) IRT vendor is increasingly an additional step in formal search strategies. Two different approaches were revealed. In one approach, secondary vendors were simply held to the same success criteria as were the winners of the primary search. In another approach, a subset of criteria were held in common between primary and secondary vendors, but with other, different criteria considered for the secondary vendor. For example, while a minimum company size might be a vital criterion for the primary vendor, the benefits of a smaller team — with increased flexibility and speed of response — might move to the top of the list for a secondary partner. Likewise, differences in customization costs and configuration practices might be paramount if smaller studies and/or ‘pinch hitting’ is to be a secondary vendor’s primary role. A smaller vendor who emphasizes ease of configuration may, for example, eclipse a second larger vendor who relies more heavily on up-front, franchise customization. In any case, the key to choosing a secondary vendor is to take the time to develop a clear understanding of what constitutes a winning set of secondary capabilities for your company’s given needs.

Dynamic Randomization — Striking a Balance

Case Studies

The Problem:

Randomization — that is, the truly random assignment of patients to a treatment group in a clinical trial — is the gold standard approach to producing statistically valid results in drug studies. Randomization is intended to eliminate bias — theoretically, the myriad of variable and potential variable differences between patients, both known and unknown, should even out over time in infinitely large samples. But study sample sizes in the real world are not infinite. In many cases, they’re not even what one would call ‘large,’ mathematically speaking. In real life scenarios, such as new drug trials, a study can wind up having a serious imbalance in prognostic factors and assignment to study treatment groups. Serious enough, in some cases, that imbalances can call study results into question.

The Solution:

Dynamic Randomization is an alternate strategy in the biostatistician’s toolbox. In a dynamic approach, there is no pre-existing randomization schedule as there is for studies using static randomization designs. Rather, the randomization table is dynamically built as the study proceeds. For each new patient to be randomized into the study, the IRT algorithm takes into account the balance/imbalance that will result from the assignment of the new patient to each treatment group, and assigns that patient to the group that will best serve the goal of balancing group size and, as study may require, key variables. Factors that might be considered include gender, age, stage of disease, or certain aspects of an individual’s past medical history. Dynamic randomization is sometimes referred to as a ‘minimization’ algorithm because it minimizes the imbalances in patient assignments. ICH has accepted the use of these dynamic techniques as a valid approach to randomizing subjects for drug trials.

Veracity Logic’s dynamic randomization algorithm is available as one of several randomization tools that are part of our standard CORE platform. When applied to a project, dynamic treatment assignment is tested as part of the standard project startup validation process. Three sample randomizations (with 150 subjects in each sample) are produced and provided to the client’s biostatisticians for review and approval prior to releasing the system for customer testing.

Predictive Inventory – Optimizing Drug Supply

Case Studies

The Challenge:

One of the greatest challenges in the conduct of a clinical trial is managing the expensive and often limited supply of investigational drug needed for the project. Anything that can help reduce waste and shipping costs while ensuring that clinical sites will have the drug they need when they need it is on the ‘most wanted’ list for the pharmaceutical industry. Since Interactive Response Technology (IRT) is one of the primary tools for drug assignment during a trial, the challenge has to be confronted by IRT vendors. How can control be achieved and maintained?

The Solution:

Veracity Logic’s Predictive Resupply algorithm is one of the tools for achieving efficient waste reduction while retaining an adequate drug supply where drug is needed. The algorithm takes into account a myriad of variables that impact on drug needs and timing. For example, the expected early withdrawal rate anticipated for a study can impact on the quantity of backlog maintained at a site for patient visits. Likewise, a study’s projected screen fail rate may determine the quantity of supply shipped to sites prior to randomization. The optimal number of inventory days at a site, the frequency of shipments desired by the sponsor, and shipping duration are also key impact variables that contribute to intelligent drug control.

Veracity Logic adds two more critical features to its proprietary predictive algorithm — the ability to control all key variables at the individual site level, and the ability to easily modify, on a configuration basis, the values assigned to each key variable throughout the clinical trial. In other words, we make Predictive Resupply sufficiently flexible to meet the changing, real-life needs of a study in progress.

Meet Veracity Logic at SCOPE 2017…

Events, Newsletter Archive

The 8th Annual SCOPE Summit, taking place January 24-26, 2017 in Miami, FL, will offer three stimulating days of in-depth discussions in 13 different conferences, 6 pre-conference workshops and 2 symposia focused on a myriad of issues related to clinical trial planning and management, including domains seminal to the world of Interactive Response Technology (IRT) — e.g., Data Integration, Site Management, Patient Engagement, Mobile Tech, Project Management, Outsourcing, Forecasting, Quality in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and more!

Veracity Logic’s user-friendly IRT system, VLIRT®, has been deployed for global trials in more than 50 countries and 45 languages over the past decade. Our system—and our team—are well known for their time-sensitive adaptability to the realities clinical trial execution. We’ll be there front and center at the conference in Miami, looking forward to an impromptu exchange of ideas and creative liaison with Sponsors, CROs, Clinical Suppliers, and Vendors. We’d love to hook up!

Third-Party Integrations…Reviewing What Matters

IRT Essentials

With the cost of executing clinical trials continuing to spiral upward, Sponsor and CROs are increasingly relying on the ability to integrate multiple service providers on a single study. Integration…true integration, that is…must accomplish three key procedural (and thereby cost) savings regardless of the types of applications/tools being integrated:

First, the integration must eliminate costly and inefficient redundancies, and the reconciliation activities they inevitably engender. Second, data sharing between systems must occur in close to real-time in order to avoid misinformation and the wasteful time/cost consequences misinformation can generate. Third, integration must be able to be accomplished easily and flexibly, without causing long delays in startup timelines and, hence, negatively impacting project budgets. Fourth, the integration must be reliable–that is, users must be able to feel confident that data is accurately and consistently being conveyed.

Veracity Logic’s approach to integrations between its IRT system and leading EDC platforms in the field today meet all four of these critical criteria. Data initiated by the IRT — for example, screening IDs or patient randomization data — are shuttled on a real-time, transactional basis to the EDC system. There is no need to enter the same data twice, thus eliminating the need for reconciliation. Error monitoring and correction processes are built into the our approach to integration, enabling users to feel confident in the status of the integrated database. For example, should a transmission fail– either on the IRT or the EDC side of things — an email is automatically sent to IRT staff who can then take the necessary steps to address the issue and retransmit the file.

Want to hear more?

Direct-to-Subject Shipping

Case Studies

The Challenge:

In order to help meet global enrollment targets, the Sponsor wanted to reduce the number of clinic visits each subject would need to make while still being able to assign drug every week. The goal was to find a way to deliver drug directly to subjects at home, and on a discretionary basis. Additionally, the Sponsor wanted to allow sites/subjects to be able to choose (and change their minds if need be) at a visit level whether to receive drug at home or by visiting the clinical site.

The Veracity Logic Solution:

A Direct-From-Depot option was added to the IRT system for all visits at which direct-to-home shipping would be allowed. At the Site level, the list of Resupply options in which the Site could participate was expanded to include the Direct-to-Subject option. At the Kit level, the system defined whether a particular kit type could be sent direct to Subjects (e.g., run-in kits were excluded from direct-to-subject). When all three key variables – Subject Activity, Site Resupply, and Kits – were in agreement, Direct-to-Subject shipping was enabled. The Subject visit was recorded, and an Activity Notification was sent to the warehouse with a request that the assigned kits be shipped to the subject’s address (on file at the warehouse).

Shipment options could be modified by each clinical site as needed throughout the study by means of a simple configuration change. By these methods, sites were able to easily adjust to the subject’s preferences while boosting enrollment and compliance.

Let Veracity Logic help with your study challenges!