Currently most sponsors perform randomization using an Interactive Voice Response System (IVRS) so that treatment codes for individual patients are no longer available at the sites for inspection.
The IVRS utilizes a dynamic randomization system using an adaptive minimization technique for pre-specified stratification variables. The randomization algorithm evaluates previous treatment assignments across the different strata to determine the probability of treatment assignment. There are no fixed randomization lists available prior to enrollment of patients and there are no pre-determined randomization schedules. The randomization algorithm is the source document and is supposed to be signed and dated prior to the time when the first patient is randomized into the study. An external vendor is used to manage the treatment allocation codes. Once a subject is found to be eligible for a trial, the investigator contacts the IVRS vendor and provides details about the subject including their stratification factors. Typically sites receive confirmation faxes from the IVRS vendor that include relevant patient information such as the date of randomization, the date of last visit and the date the last medication was assigned.
In emergences, investigators must call the IVRS vendor to break the treatment code since there are no longer envelopes with patient numbers and treatment codes for investigators to open at the sites. Treatment codes may be released to external vendors prior to the final analysis in order for plasma concentration analyses or PK modeling to be performed in patients receiving the new investigational treatment. Treatment codes may also be released or partially broken up to the code level (e.g. treatment A, B) for the Data Safety Monitoring Board (DSMB) and may be completely unblinded if the chairman of the DSMB requests it. Treatment codes are released to the sponsor or contract research organization after the official analysis database lock.
Nowadays, the IVRS moves to the web-based system. The term is also becoming IWRS (interactive web response system). It could be the situation, when we use the term IVRS, it actually means IWRS.
The utility of the IVRS/IWRS is not just limited to the randomization. It can be used in other areas as well:
- Collecting the clinical efficacy outcome. For example, in IBS (Irritable Bowel Syndrome) study, the IVRS is used to collect the information about the presence or intensity of several IBS related symptoms daily (such as satisfactory relief, Abdominal discomfort or pain, Bloating, Stool frequency, Stool consistency...)
- Patient Reported Outcome (ePRO)
- Outcome research
- Cohort management (open/close a cohort) in dose-escalation studies
- Patient registry / registry studies
- Drug supply managment / Study drug inventory tracking
5 comments:
Why should a sponsor look beyond ePRO?
It is a known fact that it take huge amount of capital, usually in billions of dollars to conduct and finally launch a dug into the market. It is also known that there are several studies that are either terminated or stopped half way due to several reasons technical and non-technical associated with it resulting in wastage of time and money both. Patient related data capture during a clinical trial plays an important role in the making of a drug. Through out the different phases of clinical trials information from patients are taken for efficacy, BA, BE measurements and make a considerable part of the trials or study. A lot of sponsors have been using ePRO to collect patient reported outcome, still makes only 30-40 % of studies being conducted using EDC and further less using ePRO.
It is time that sponsors look at more cost effective ways to gather PRO from subjects under trials and keep abreast with the pace of developing technologies. The next big wave in capturing PRO for clinical trials is the use of mobile phones and I am sure there are many a company that are working on it. Mobile phones are going to be the next computers that would enable users to manage all their communication and information transfer over mobile phones.
What can a sponsor look at from a mobile phone based PRO?
Well there are quite a few things for a Sponsor or for that matter a CRO to be looking at, when it comes to mobile based PRO system.
Faster
Compliant
Cost effective
Patient safety
Logistically simpler
Less erroneous data
Data integrity and security
New and improved features
A information management system
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The major benefit of IVR system for companies is to help you save time and money. Picking up telephone calls takes a lot of time since IVR systems can take care of the majority of the common questions that a company receives.
In telecommunications, IVR allows customers to interact with a companys host system via telephone keypad or by speech recognition, after which they can service their own inquiries by following the IVR in Brazil dialogue. It provides an aid for transferring calls to recorded playback. IVR in Brazil systems can respond with prerecorded or dynamically generated audio to further direct users on how to proceed.
there are 3 main ivr service provider 1st is IVRguru, 2nd exotel, 3rd knowlarity,
and according to my knowledge ivr guru is best because my personal experience. Read More
Why Your Business Needs an IVR System Today
An IVR system acts as a virtual receptionist, intelligently routing callers to the appropriate department or agent. By automating this process, an IVR system reduces wait times and minimizes the chance of callers being transferred to the wrong person. This streamlined call handling not only enhances customer satisfaction but also improves the overall efficiency of your business operations.
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