Integrated voice response system clinical trials

These systems can be utilized in randomisation to support minimising variability of the evaluation and unbiased data reporting. Through automated system reports, real-time information can be reported to the study manager via fax and email.

In conclusion, IVRS and IWRS facilitate smoother data collection and integration for characteristically expensive clinical trials where completion can take many months or years.

This is applicable to single centre and multicentre trials focusing on different indications. Real-time data reporting assists the study team in collecting and integrating accurate data without major delays that can affect the overall outcome of the trial. For future development of clinical trials, there is a significant requirement for seamless coordination and integration of data from all areas of study into a central lab for analysis.

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Related Comment Burden of brain cancer will continue to rise in the US ageing population. All will be enrolled at M. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Last Update Posted : July 30, Study Description. We hypotheses that: Patients in the MDASI-IVR plus triage group will have less symptom burden less symptom severity, less symptom related interference, and better satisfaction of symptom control, better physical and emotional well-being over the month of the trial compared to the control group.

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. Detailed Description:. FDA Resources. Arms and Interventions. Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to A report of severe symptoms will be sent to your doctor or nurse.

Outcome Measures. Primary Outcome Measures : To study the effectiveness of the interactive voice response system IVRS , which is designed to send a report to a patient's doctor about severe symptoms they are experiencing. This module can be used to activate or deactivate the sites, to set a predefined drug supply to sites.

This module is accessed by the sponsor. This module is used to open or close cohorts based upon the set conditions defined in protocol. In addition, the sponsor can update the cohort target based on the requirement.

Using this module, the sponsor can update expiration date of product that will be shipped to sites. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments to reduce bias.

Based on randomization number, the patient receives appropriate treatment in the trial as per the randomization plan. Dosing algorithms are built in IxRS to dispense investigational drug to patients as per the protocol defined dosing schedule and treatment arm. The patient receives a unique kit number or box number after drug dispensation call. Earlier Investigators had to assign kits manually to subjects while performing drug dispensation. Receipt of drug at sites can be confirmed through this module.

In addition, the condition of drug received and its timeframe can be mentioned during this call. This module is used for unblinding of subjects in case of any serious adverse event either by subject number or by kit number assigned. This module can only be accessed by sponsor and statistician.

Drug supply management to sites can be governed through this module. Once quantity of drug goes beyond defined number at site, required quantity will be automatically shipped to respective site s to make sufficient availability of drugs at site. As a technology, IxRS is very much robust and user friendly for end users; however, at backend, it has very complex programming codes written for each and every module that is been built.

These IxRS modules need to be thoroughly validated both at programming stage by service providers and from end user point of view by the sponsor or CRO. Validation of IxRS becomes a vital step as there is direct impact on patient randomization, drug dispensation, and unblinding, which are critical modules for any study from safety, regulatory, and business perspective.

High quality validation is, therefore, critical before deploying IxRS. Figure 2 elaborates one of the processes followed for IxRS validation by sponsors. Food and Drug Administration FDA has outlined few regulations[ 9 ] and recommendations for computerized systems used in clinical research.

Some of the regulations and recommendations have been listed below:. IxRS acts as central hub for other systems used in clinical research. Pharma companies need to opt for emerging and innovative technologies in clinical research to compete in global competition to utilize maximum benefits for patent filed before its expiry.

Implementation of IxRS into clinical studies can accelerate trial by remote recruitment, appropriate randomization, and automated product management. With evolving technologies, IxRS can be easily implemented into studies and can be accessed remotely through telecommunicating devices such as phone, mobile, and IPad even from the areas where internet facilities are not available. Hence, IxRS can become indistinct choice for most flexible, user-friendly, and robust tool for the pharma companies.

However, today we can see rapid growth in the use of IxRS in clinical trials. I am grateful and would like to acknowledge the expertise and guidance provided by Dr. Nimita Limaye, Mr. Deven Babre and Mr. Sharad Sharma that greatly supported this article. National Center for Biotechnology Information , U.

Journal List Perspect Clin Res v. Perspect Clin Res. Vrishabhsagar Ruikar. Author information Copyright and License information Disclaimer. Address for correspondence: Mr. Vrishabhsagar Ruikar, Flat No.