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M-09: Disseminating Regulatory Self-Study Tools: A Study of the Efficacy and Promulgation of USC’s Clinical Trial Quality Training

Poster Presenter

Advaita Chandramohan

Undergraduate Research Associate
University of Southern California
United States

Objectives

This research was conducted to assess the effectiveness of a training module on clinical trial monitoring created by the International Center for Regulatory Science at USC and to gain knowledge about the dissemination of educational resources within the field of regulatory science in academia.

Method

Utilizing a implementation science framework, the training module was monitored during the continued phases of full implementation, innovation, and sustainability. This was actualized through user testing groups, publicized dissemination events, and user data collected from the online module itself.

Results

Currently, the training initiative has been live on the USC Regulatory Science Website for four months, after being introduced to institutes across the country through the TIN National Open Forum in mid-November, 2018. Over this time period, the module has gained 118 users and has had a total of over 3,700 views on its various sections. This illustrates the extensive use of our module even in its early stages of implementation. The effectiveness of the module was also measured through user focus groups. When 13 research professionals were asked if the module allowed them to conceptualize cases from the point of view of a monitor, all of them said yes and also answered that they would recommend the training initiative to other medical professionals. Additionally, comparing pre- and post-survey questions regarding the content of the module illustrated a 70% growth in the learning comprehension of the users. Despite predominantly positive reviews, feedback has also been collected on possible improvements to the resource, such as rectifying technical flaws and adding additional features that would aid in the instructional value of the module. Furthermore, the increase in users was measured after each large dissemination event in order to measure the impact of each event in spreading the use of the module. The methods of advertising each event were also recorded in order to see if certain methods of spreading information regarding the module were more useful than others. These methods were then quantified based on growth of usership, allowing them to be compared and then ranked in way that is helpful to all research professionals looking to find the best way to disseminate resources they may want to share with the rest of the regulatory science field. Data is currently being analyzed and findings will be reported.

Conclusion

From the exploration stage of the implementation science framework, previous assessments were conducted to understand the need for a training module. USC collected data from 165 clinical research professionals (CRPs) regarding monitoring levels in investigator-initiated trials. Out of the 165 CRPs, 36 percent of professionals stated that they did not have someone assigned to perform monitoring functions for their clinical trials. We believe this number may be even higher, as we have found that research personnel may not understand that monitoring functions cannot be conducted by someone who performs study-related activities. It is believed that this discrepancy is due to the lack of easily-accessible monitoring training resources within academic institutions. In contrast, industries have the resources to create quality management systems and establish standard monitoring routines within their industry-initiated trials. This discrepancy prevents data from easily transferring from academia to industry, leading to a loss of valuable academic research. In order to address this need, USC created an online training initiative that is now in its stages of implementation on a national scale. Through feedback from users and data collected by the module itself, valuable insight has been gained not only on the effectiveness of the module, but also on the various methods of dissemination we utilized to spread the training initiative to other research facilities. This information will be used to improve on the promulgation of other regulatory training initiatives. In order to record this information for future use for both this initiative and regulatory science training resources in general, all data collected regarding the module was stored and is being used to create a document that details the dissemination efforts and uptake. Once completed, a manuscript will be published for the use of other institutions who are looking to distribute their educative resources as well.