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Protocol Procedure Complexity In Clinical Trial

  • Mark704 

Over the past few years, an increasing protocol complexity has garnered a lot of attention among clinical trial experts. It has lead to various important studies beginning from meditating insights metrics warehouse which reveal that clinical studies have reached to a significant level of complexity in the recent times. In spite of a larger increase in metrics in the first half of the past decade and continued warnings from experts, the complexity continues to be on an upward surge through admittedly less steep and trends. A quantifiable or reputable measure of effort is necessary to conduct a study on the protocol complexity value which was supposedly a new addition to Medidata Insights metrics warehouse. There is a factor called Relative Value Unit (RVU) and it will be multiplied by the quantity of each trial procedure and clinical research activity conducted per completed patient. The result of this calculation will be used for the association of burden on sited and to conduct relevant studies.


The impact of an increased protocol complexity will be very intense while considering it in correspondence with the study of drug development. Further, the outputs lead to an increased execution burden on sites yielding costlier clinical trials and potentially greater issues with site training and performance. During a clinical trial process, nearly 15 to 30 percent of the data collected will not be used on an average while reviewing a new drug application. The end result of this process implies direct costs incurred due to the increase in added complexity without an increase in corresponding added values. It also becomes responsible for negatively impacting patient recruitment and retention. The prediction says that such types of negative impact on patient experience happen in clinical trials because of the increased frequency and invasiveness.

There are three kinds of key metrics such as eCRF complexity; a number of on-site monitoring days and the amount of SDV are rising steadily from the insights metrics warehouse. Besides monitoring costs and the burden, the increase in protocol complexity also drives a plausible deduction out of correlation among different measures obtained out of the reasonable conclusion. It also controls the increase in eCRF complexity and design timelines including monitoring costs. Even though the complexity of protocols is constantly increasing across the industry a peripheral discussion on this prevailing scenario still holds the prime focus in clinical trials. An important addition this list is screen failure rates. Basic screen failure rates in a majority of the clinical trials related to protocol procedure complexities suffer from high loss across the industry.

Given the pressure to control costs and streamline trials, is there any way clinical R&D organizations can reduce the cost of clinical trials and the burden on sites and patients when protocol complexity continues to increase steadily? What is your experience with protocol complexity? Do you find your protocols, or those of your partners, to be more complex? If so, how does increasing complexity impact other aspects of your clinical operations downstream? As always, Medidata is interested to hear your take on this result.

These are some of the serious concerns surrounding protocol procedure complexity in clinical trials. Few complexities could be addressed based on testing its procedural complexity ratios i.e. the given procedure will be directly linked with the number of unique procedures or the amount of activity associated with it. However, a substantial rise in procedure complexity can be reflected while increasing per patient costs in the subsequent clinical trials. This can be an exception in the case where the rapidly growing numbers of medical procedures perform procedural complexity clinical studies at no cost to commercial companies that are sponsoring the studies.           

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