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International Clinical Trials

Keeping Watch

Christina Hughes and Kimberly Foulds at United BioSource Corporation review an approach that facilitates the timely review and monitoring of clinical data

Clinical trials involving subjective clinician-rated endpoints rely on individual interpretation, which can potentially lead to ‘noisy’ data and sometimes, as a result, failed or inconclusive studies. Video surveillance is a novel technology recently introduced for use in clinical trials involving subjective endpoints in order to curtail data variability. Video surveillance methods transcend their traditional paper-based counterparts by facilitating the evaluation of not only the actual rating instrument results, but also the behavioural and situational habits of the clinical trial site rater. This article will examine how video surveillance can:

1. Improve data quality

2. Assist sponsors in their goal to ensure that ratings are done carefully, thoughtfully, and in accord with study conventions

3. Provide continuous monitoring and support to the sites and raters throughout the study

IMPROVE DATA QUALITY

Improving rater accuracy and reliability as a means of improving data quality and enhancing trial success has been a major focus in the central nervous system (CNS) clinical trials industry which frequently relies largely on subjective endpoints. CNS clinical trials use subjective clinician-rated endpoints and are, by definition, open to clinical judgement, unlike studies which rely on physiological or objective tests (for example blood pressure or temperature). This can lead to ‘noisy’ data, which in turn can produce failed or inconclusive studies.

Trial errors, including design, procedural, data recording and analytical errors, all contribute to problematic findings within CNS clinical trials (1). The requirement for improved pre-initiation study design is documented more frequently in scientific literature. Each of these components needs to be reviewed in conjunction with a solid monitoring programme. It is becoming more common for clinical trial sponsors to use some type of ratings surveillance in their studies, especially when presented on a global scale.

However, the addition of video surveillance is a newer methodology being explored by pharmaceutical companies to mitigate and/or control the behavioural components of clinician-administered instrument ratings. In addition to rater bias and inter-rater reliability, several behavioural issues have been observed and documented in the literature, such as poor interview quality, rushed interviewing, heightened rater enthusiasm, and a distracting interviewing environment (2,3).

ASSISTING SPONSORS IN THEIR GOALS

Video surveillance is a newer technique being employed in CNS trials that use subjective, clinician-rated instruments to help address the behavioural issues commonly attributed to ‘noisy’ data. This method assists in the goal of ensuring that ratings are performed carefully, thoughtfully and, most importantly, in accordance with study conventions. By providing continuous monitoring and support to the sites and raters throughout the study, the hope is that more accurate study outcomes will be achieved.

The ways in which video surveillance methods may achieve improved data quality in a CNS study are by providing continuous monitoring and support to the sites and raters. When used in conjunction with traditional rater training methods at the beginning of a trial, video surveillance allows for continuous evaluation of both scoring data and behavioural methods being utilised.

The use of video technologies in clinical trials isn’t new. Video conferencing technology has been in operation in support of remote centralised ratings of patients in the US for several years. The need for sponsors to monitor the quality of their clinical trials has led to the expanded use of these technologies, especially outside the US where both technical and language obstacles make video monitoring difficult logistically. Standardising the use of video monitoring with internet-based technologies will allow for its use in more clinical trials.

A variety of methodologies exist that can be implemented when using video surveillance. These can include independent confirmation of all ratings by third parties periodic quality assurance of site behaviour (4).

The acceptance and implementation of surveillance programmes relies on careful collaboration among sponsors, clinical trial sites and study subjects. While comprehensive video-based surveillance programmes are still somewhat new to clinical trials, recent studies have found the systems to be well accepted by both sites and patients (4).

CONTINUOUS MONITORING & SUPPORT

Traditional means of monitoring, as well as site evaluation, relies primarily on the use of clinical research associates and site monitors. But the rapid growth of clinical trials, especially in emerging markets, makes traditional site monitoring even more difficult. Continuous monitoring through the use of surveillance systems allows for a timelier and immediate evaluation of potential site issues, and provides a feedback mechanism for traditional site monitors. The identification of potential issues through remote technologies can assist monitors in rectifying specific issues where necessary, as well as providing the sponsor with increased reassurance that quality is not compromised during the interval between site monitoring visits.

CONCLUSION

The use of video surveillance in clinical trials can assist in reinforcing the continuing reliability of data collected using clinician-rated endpoints. Moreover, the video surveillance approach facilitates the timely review and monitoring of these data. Errors or discrepancies uncovered during conventional monitoring practices would likely be discovered weeks or even months after the occurrence based on traditional monitoring schedules. A video surveillance system buttresses a methodical approach to identify and remediate potentially suboptimal raters in a timely manner. The system is cost-effective and geographically scalable, making it an invaluable tool for improving subjective ratings precision.

References

1. Baigent C, Harrell F, Buyse M, Emberson J and Altman D, Ensuring trial validity by data quality assurance and diversification of monitoring methods, Clinical Trials 5: pp49-55, 2008

2. Yang H, Cusin C and Fava M, Is there a placebo problem in antidepressant trials? Current Topics in Medicinal Chemistry 5: pp1,077-1,086, 2005

3. Dworkin R, Katz J and Gitlin M, Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain, Neurology 65(12-4): S7-19, 2005

4. Schoemaker J, Richa Gaur R, Sharma T, Berkowitz L and Szegedi A, Expert Rater Assisted Score Evaluation (Erase): A New Method to Enhance Signal Detection in Randomized, Placebo-Controlled, Clinical Trials, ISCTM, 21 February, 2008


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Christina Hughes is the Acting Regional Manager of United BioSource Corporation’s Goring, UK, and Prague, Czech Republic offices. Christina manages project teams in the execution of UBC’s global investigator training, scale management, data surveillance and cognition services programmes. Previously, Christina worked for Cap Gemini Ernst & Young and Deloitte Consulting in their healthcare divisions. Christina has a degree in Biology from Yale University and an MBA from the University of Pennsylvania.

Kimberly Foulds is a Senior Project Manager with United BioSource Corporation (UBC) Specialty Clinical Services. She joined UBC in 2007 and has over 12 years of project management experience in the biotechnology and pharmaceutical industry. While at UBC, Kim has managed the delivery of rater training and rater surveillance programmes for multiple mood disorder, schizophrenia and Alzheimer’s disease global clinical trials. Kim earned her Master’s degree in Biotechnology in 2001 from Johns Hopkins University.

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