What is the purpose of the interactive voice response telephone system?
What is IVR in clinical trials?
How long does a phone call after surgery last?
How to report severe symptoms to a doctor?
How long does it take to study the effectiveness of the interactive voice response system?
How many patients are in the Anderson study?
Which group will have more frequent documentation of symptom management in line with treatment guidelines?
See 4 more
About this website
What does IVRS mean in clinical trials?
Interactive Voice Response SystemMasking:None (Open Label)Primary Purpose:Supportive CareOfficial Title:A Randomized Clinical Trial of the Efficacy of an Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic SurgeryStudy Start Date :July 2006Actual Primary Completion Date :June 20106 more rows•Jul 20, 2007
Is IVRS the same as IRT?
SDC's IRT randomization services can make even the most complex clinical trials run smoothly and efficiently. Also known as IWRS/IVRS (Interactive Web/Voice Response Systems), IRT automates your patient randomization, kit assignment, drug supply, and inventory management.
What is IRT used for in clinical trials?
IRT stands for Interactive Response Technology. Another term that has been used to describe this technology is 'randomization and trial supply management'. Essentially, IRT helps clinical trial sponsors and sites manage the patient and drug supply logistics throughout a clinical trial.
What is IVR in pharma?
IVR stands for Interactive Voice Response. It is technology that allows a computer to interact with humans through the use of voice and “Touch-Tone” inputs via a phone or keypad. A pharmacy IVR usually offers 3 different options or tiers of service for an IVR.
Is medidata an IRT?
Medidata Rave RTSM (formerly Balance) heralds a new generation of cloud-based Interactive Response Technology (IRT) capabilities. As sponsors strive to realize greater ROI, clinical trials increasingly face changing requirements and priorities.
What is IRT process?
The item response theory (IRT), also known as the latent response theory refers to a family of mathematical models that attempt to explain the relationship between latent traits (unobservable characteristic or attribute) and their manifestations (i.e. observed outcomes, responses or performance).
What is an EDC in clinical trials?
Electronic data capture, EDC, is a software used for collecting clinical trial data. An electronic case report form, or eCRF, is a digital (usually web-based) questionnaire for collecting data about a study participant.
What does a Ctms do?
A clinical trial management system (CTMS) is a software system used to manage clinical trials in clinical research. This CTMS will serve as a single, centralized, web-based enterprise resource to support clinical research studies conducted within or across the three institutions.
What does IRR stand for in clinical trials?
An individual research result (IRR) is “a finding concerning an individual contributor that has potential health or reproductive importance and is discovered in the course of research on the focal variables under study in meeting the stated aims of the research project.” (Id.).
What is IRT calling?
IRT: This refers to systems in which callers are able to use a phone or another means to interact with the system. IxRS: The “x” varies based on the modality, but this acronym refers to IRT's different iterations as interactive response systems.
What does IxRS stand for?
An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend.
What does a Ctms do?
A clinical trial management system (CTMS) is a software system used to manage clinical trials in clinical research. This CTMS will serve as a single, centralized, web-based enterprise resource to support clinical research studies conducted within or across the three institutions.
What is Susar in pharmacovigilance?
SUSAR. An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SAR is the abbreviation for Serious Adverse Reaction, and SUSAR for Suspected Unexpected Serious Adverse Reaction.
Good Practice Guide: Interactive Response Technology
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Selecting and Implementing IRT Systems for Clinical Trial Supply ...
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Interactive voice response system (IVRS) in health care services
Recent advances in telecommunications technology have created opportunities to enhance the quality of health care services through telehealth, the use of telecommunications and information technologies to deliver health care. However, the diverse technologies and applications encompassed by teleheal …
Why is simple unconstrained randomization used?
But simple randomization is rarely used because of the need to protect the trial from imbalance in the overall numbers allocated to treatment and from temporal bias in the allocations. For these reasons the randomization procedure is often restricted by some form of blocking, the most common being random permuted blocks. The methodology, issues and practical considerations relating to the use of blocked randomization are described. Particular attention is paid to the issue of potential selection bias, which may arise from the predictability of tail allocations towards the end of any block of treatment allocations if the past allocations in the block are known or can be guessed. The merits of using unequally sized blocks to avoid selection bias are discussed in detail. Inference following blocked randomization is also discussed. Alternative forms of blocking are described; these include lists generated from the maximal procedure, the use of rows from Hadamard matrices, Zelen's balanced blocks procedure and mixed randomization. Practical considerations relating to the use of blocked randomization are described including software used to generate random blocks. Also covered are considerations relating to the use of electronic systems to automatically perform allocation from a pre-defined randomization list; the use of such systems is becoming increasingly common with the advent of telephone interactive voice response (IVR) and web based randomization systems.
How does IWRs affect clinical trials?
Especially, the integration with cellphone communication function makes the system break the limitation of web network, and improves the practice of the system. The application of IWRS can improve the accuracy of randomization, decrease the bias, reduce drug losing, simplify administration link, and save research cost in quality control of clinical trials.
What is interactive response technology?
Background: Interactive response technologies are used in clinical trials to provide services such as automated randomization and medication logistics management. The objective of this article is to investigate the usage of telephone (Interactive Voice Response) and web (Interactive Web Response) interfaces of interactive response technologies at clinical investigator sites in clinical trials, to obtain information about the preferences of interactive response technology end users between the telephone and web interfaces, and to explore the relevance of the telephone interface in this setting. Methods: The data consist of an online survey conducted in spring 2016 with clinical investigators, study nurses, and pharmacists in 13 countries. Results: Ninety-eight percent of survey respondents preferred the web interface over the telephone interface, the most important reason being superior usability. However, the respondents indicated the usability of interactive response technology interfaces is not optimal, and lack of integration and consistency across systems is common. A vast majority of interactive response technology end users at clinical sites prefer to use the web interface over the telephone interface, but most also feel there would need to be a back-up system. Conclusions: Based on the results, it would be beneficial to improve the usability of the interactive response technology interfaces, and to increase consistency across systems from the current level. Support to and training of the users, as well as clarifying the responsibilities between sites and the sponsor should also be a focal point. Study sponsors should explore with interactive response technology service providers how removing the telephone interface would impact future studies, and whether there could be a more efficient means to achieve a reliable back-up to the web interface instead of a dedicated telephone interface.
What is blocked randomization?
This chapter focuses on blocked randomization methods, which are used to balance treatment groups overall and, if needed, for time trends and prognostic factors. It deals with two types of blocked randomization. The first instance is in which the block size or length equals the required sample size. Abel terms this complete balanced randomization. The second is random permuted blocks, in which several blocks make up the randomization list. The permuted blocks procedure involves randomizing subjects to treatment by constructing a randomization list partitioned into blocks. Permuted blocks are used when there is a perceived need to protect against time trends in patient characteristics and/or outcomes. The chapter discusses schemes using a single block for the whole trial. This is followed by a discussion on the inference and analysis following blocked randomization.
Why are clinical trials so challenging?
Clinical trials face increasing challenges as a result of the drive to bring new drugs to market faster. The acceleration of clinical research leads to increased pressure to control study timelines. Patient recruitment is often difficult to control, and techniques able to reduce recruitment time are of great value to many studies. Interactive Voice Response (IVR) systems are traditionally used to perform randomisation, emergency code-break, and medication supply management. More recently, however, IVR has been used to collect patient recorded data. We report practical experience of using IVR to accelerate patient recruitment in two depression studies
Why are phase I and phase II studies important?
Phase I and early Phase II studies generally have the aim of establishing the safety, tolerability and pharmacokinetics of one or more doses and formulations . Traditionally many of these studies have tended to be conducted at a single site so that the randomization, dosing, dispensing, blood sampling procedures and progression between successive cohorts could be tightly managed. Allowing competitive recruitment may be particularly important in patient studies in populations where it is difficult to recruit. RTSM (Randomization and Trial Supply Management) technology allows management of the recruitment to each cohort which would be difficult, if not impossible, to coordinate with many centers. Examples are given in this letter to show how RTSM technology can be used to manage randomization, cohort progression and dosing in multicentre early phase trials. Additionally, a sample survey of the incidence and types of early phase cohort studies performed by Perceptive Informatics was undertaken. The survey of our database showed that many early phase studies are conducted in multiple sites and countries with fairly low numbers of patients per site; this reflects the need for speed on the critical path for drug development.
Why are clinical trials going global?
As a result of slow patient recruitment and high patient costs in the United States , clinical trials are increasingly going global. While recruitment efforts benefit from a larger global footprint, the supply chain has to work harder at getting the right drug supply to the right place at the right time. Certain clinical trial supply chains, especially those supplying biologics, have a combination of unique attributes that have yet to be addressed by existing supply chain models. These attributes include a fixed patient horizon, an inexible supply process, a unique set of service-level requirements, and an inability to transfer drug supplies among testing sites. We provide a new class of multi-echelon inventory models to address these unique aspects. The resulting mathematical program is a nonlinear integer programming problem with chance constraints. Despite this complexity, we develop a solution method that transforms the original formulation into a linear integer equivalent. By analyzing special cases and through numerical study of both real-life and simulated examples, we demonstrate the effectiveness of the solution and develop insights into inventory positioning and the cost drivers in clinical trial supply chains.This article is protected by copyright. All rights reserved.
Why is IRT better than other systems?
IRT has the advantage of speed and accuracy, despite occasional web browser compatibility issues and translation limitations. Prompts are displayed on screen so the user dictates the pace rather than a recorded voice announcing and repeating information. It’s also more accurate in regards to data entry as users can see what they are selecting on screen rather than pushing buttons on the telephone keypad to make selections. IRT does not require any specialized hardware or telecommunications vendors, anyone with an internet connection can access the system.
Why did IVRS come about?
IVRS came about as a way to bring computerized randomization and drug management functions to investigational sites before internet connected PC’s were commonplace. Since telephones are ubiquitous, sponsors had a way to control randomization and drug supply.
What is IRT technology?
Interactive Response Technology (IRT), sometimes also called Interactive Web Response (IWR), uses the internet and a web browser instead. Prompts over the phone are replaced with prompts on a computer screen to interact with.
Is IRT more popular than IVRS?
IRT has become more popular since internet-connected computers, at investigational sites around the world, have become commonplace. Both technologies have some clear advantages and disadvantages. IVRS has been around since the early days of computerized randomization and drug management.
Is IVRS slow?
For example, local toll free numbers can be changed without prior notification. Speed – IVRS is also fairly slow when compared to IRT, as the system must read out prompts, repeat entries and request confirmation inputs.
Does IRT require a specialized hardware?
IRT does not require any specialized hardware or telecommunications vendors, anyone with an internet connection can access the system. So to sum it up. IRT is definitely gaining ground over IVRS, as more sites and users incorporate the internet into their daily operations.
Why 4G Goes By Agile RTSM Instead of IRT?
So, back to the original question at hand. Why would we choose to go with RTSM to describe our offering and add another acronym to the mix?
Why is RTSM important?
There is a treasure-trove of data housed in RTSM systems that can be used to streamline and accelerate clinical trials – both operationally and to enable supply chain optimization. As trials become more complex, it is more important than ever for clinical and supply to be connected.
What is IRT in computer terms?
To me, IRT is a very general term that could almost be applied to any application you use to enter data and gather information from, including websites , smart phones, etc. Using the term “IRT” is just like saying “system.”.
What is IRT in the industry?
Today - Having said that, I would say that the most widely used term in the industry today for our systems is IRT. IRT (Interactive Response Technologies) is considered more of an umbrella term that encompasses all modalities (voice, web and even mobile).
When was the IVR invented?
1990 - In the 1990s, the first clinical IVR systems (Interactive Voice Response Systems) were developed in order to randomize patients over the phone, and later, to dispense drug and resupply sites as well. For the first time, all patient kits could be interchangeable for any other equivalent kit.
When was the first parameter driven web response system invented?
2000 - In the early 2000s, with the advent of the internet, the first parameter-driven, web-based (Interactive Web Response Systems) were born. Now there were two widely used terms, IVRS and IWRS, to describe these systems depending on their modality (phone vs. web).To add to the complication, if an organization used both IVRS and IWRS, the term IxRS was coined to imply either/or.
Is the pharmaceutical industry a acronym?
The pharmaceutical industry, not unlike many others, is full of acronyms. Some are industry recognized, others are specific to internal organizations. Most of the terms are just different flavors of the same thing.
What is the purpose of the interactive voice response telephone system?
To test the effectiveness of the interactive voice response telephone system with a triage/feedback component that incorporates timely symptom assessment, feedback to physicians, critical treatment guidelines for managing selected symptoms (distress, sleep disturbance, shortness of breath, constipation, and pain) in a cohort of cancer patients during the first month post-thoracic surgery .
What is IVR in clinical trials?
This interactive voice response system (IVR) will be evaluated in a randomized clinical trial with an intervention group (IVR symptom assessment with triage) and a control group (IVR symptom assessment only).
How long does a phone call after surgery last?
The call should last from 3-5 minutes. For participants in the other group, a symptom report will also be sent to your doctor or nurse. One month after surgery, you will have a phone call from a member of the research staff.
How to report severe symptoms to a doctor?
The system can record and report severe symptoms to a patient's doctor by e-mail, fax, or pager. All patients are encouraged to report and discuss any severe symptoms to your treating clinicians. If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups.
How long does it take to study the effectiveness of the interactive voice response system?
[ Time Frame: 3 Years ]
How many patients are in the Anderson study?
THIS IS AN INVESTIGATIONAL STUDY. Up to 130 patients (65 in each group) will take part in this study. All will be enrolled at M. D. Anderson.
Which group will have more frequent documentation of symptom management in line with treatment guidelines?
Patients in the MDASI-IVR plus triage group will have more frequent documentation of symptom management in line with treatment guidelines compared to the control group.
