Implementing tried and tested clinical trial technology that provides real-time data capture supports future development of clinical trials focusing on many different indications. Interactive Voice Response Systems (IVRS) facilitate effective communication with the site and trial monitor, while maintaining command of the trial. From a Sponsor’s perspective, trial budgets can be efficiently monitored while communication with internal teams is streamlined in order to swiftly resolve any issues and lock the database according to the trial timeline.

Building an integrated database and employing IVRS and IWRS for multi-site trials

Sponsors may record clinical trial data by utilizing a number of platforms, such as IWRS (Interactive Web Response System), IVRS, EDC and CRFs; this can then be integrated into one uniform database. IVRS paired with IWRS can support multicentre study administrators and investigators to safely interact with the study database. Facilitating a more streamlined study deployment process, IVRS/IWRS systems manage the logistical issues related to the conduct of clinical trials and can be accessed anytime of the day or night through the internet or telephone connection. This allows for seamless management of drug supply, lab samples, patient enrolment and randomization, patient diaries, drug returns and reconciliation, and temperature excursions . IVRS/IWRS can be accessed from any international location worldwide and the interoperability of these systems can support strict study timelines and different time-zones for more efficiency.

Real time benefits of IVRS and IWRS

IVRS and IWRS are systems that are both growing in popularity due to real-time benefits applicable in the following processes: patient randomisation, drug assignment and inventory management, study blinding, reporting and systems integration . IVRS permits study administrators and investigators to engage with a computer database utilizing a telephone touchtone platform for real-time data input. The computer is able to reach the caller for the necessary data, simply through pre-recorded country-specific voice messages, and deliver the necessary information in response. Similarly, IWRS designates individual treatments to subjects, provides automatic verification of assignments (on screen and via email), as well as systematic reporting of trial development to the researcher. Regarding online communications, IWRS delves deeper into the data that an investigator or administrator is able to gather about the progress of the trial; this is comparable to the data processed through IVRS.

Study applications of IVRS and IWRS

These systems can be utilized in randomisation to support minimising variability of the evaluation and unbiased data reporting. As touched upon, real-time feedback from a centralised database grants a researcher the ability to allocate specific treatments – depending on indication/therapeutic area – to study groups while delivering accurate statistical analysis . Harnessing where and when to assign trial drugs saves valuable resources, hence the functionality of IVRS/IWRS in drug assignment processes is constructive. IVRS/IWRS also helps improve the study blinding process by allocating treatment groups in a controlled and unbiased manner. Through automated system reports, real-time information can be reported to the study manager via fax and email. IVRS/IWRS and the initial study preparations and documentation fit into the familiar manual processes of organisations running clinical trials, so can be utilised for systems integration.

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. Reliable IVRS/IWRS support the mitigation/minimization of risks, reduce study timelines, and cut the costs of development. 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.

 

References

  1. http://www.clinicalleader.com/solution/irt-iwrs-ivrs
  2. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/02/WC500161984.pdf
  3. http://issuu.com/mark123/docs/jcs-november-2010-ecopy/59
  4. http://www.clinicalleader.com/solution/irt-iwrs-ivrs