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People Power

It is Thursday at 4.50pm and Ann is staring at her computer, waiting for an electronic case report form (eCRF) page to refresh. She has eight more pages to enter and five more queries to resolve for one patient – and two additional patients to deal with. She also has a monitoring visit tomorrow.

Ann has been behind with her deadlines since the start of the trial, and communication with her clinical research associate (CRA) has become increasingly discouraging. She knows that working on research trials can be tough, but this one is particularly painful. She secretly hopes that at least one of her patients withdraws from the trial to lighten her workload.

EDC Promises

The potential benefits of electronic data capture (EDC) are widely known – cleaner data faster, fewer queries and better data quality, in addition to quicker turnarounds and cost savings. In 1998, the efficiencies were shown to shorten study duration by 30 per cent, decrease time to database lock by 43 per cent, and reduce queries by 86 per cent (1).

However, these benefits are mostly accrued by the sponsor, while site staff work with increasingly complex and time-consuming EDC systems. Patricia Larrabee, Founder and Chief Executive Officer of Rochester Clinical Research, recently stated: “EDC is really for data managers, not really for the people actually inputting the data” (2).

Increased Burden

From a 2009 survey conducted by eClinical Forum, 46 per cent of respondents believed they need to do more work due to EDC – double the percentage from eight years earlier (3). It seems that these new technologies have actually increased the burden on sites, with cumbersome, slow and non-intuitive systems that make their roles even more difficult.

When asked how these barriers could be overcome, respondents from a 2013 survey by Arithmos among clinical trial professionals worldwide (n=178) called for better integration with other systems (n=43); a test environment to practice in (n=32); training (n=28); e-learning training (n=28); and helpdesk support (n=27) (4). It was also found that study teams valued ease of use and training materials over the number of features and functionality in the EDC system (5).

Putting Sites First

Timely, well-planned communication and education programmes can play a significant role in improving data quality. The earlier the sites can be assessed and engaged in this process, the better.

Initially, an analysis should be performed to assess the site’s current level of competence (compared with the expected level) on the proposed EDC system, to gauge the need for training. Assessments could include:

● Clinical research experience (number and types of trials)

● eCRF platforms used

● Previous training received and rating scores

● Technical proficiency

● Access to technology

● Performance metrics from previous studies

If the EDC system cannot be modified, sponsors should consider selecting sites that have the necessary capabilities by carrying out careful feasibility assessments. The appropriate and tailored curriculum can then be designed to address training needs.

Optimal EDC Platform

If the EDC vendor or system has not yet been selected, it would be beneficial to choose the system according to user preferences – a system that fits the needs of the user rather than the other way around – to increase the chances of obtaining high-quality data.

If already selected, the challenges of that particular EDC system can be addressed through alternate means to ensure better workflow. This may include customising eCRF forms/visits and also standardising query wording and system messages to ensure that, during user acceptance testing (UAT), users feel the platform is intuitive, and workflow and communication is clearly understood between study coordinators and monitors. It is also recommended that a select group of users with varying degrees of experience be selected as the ‘elite testers’ for the eCRF platform UAT to ensure comfort levels.

In the Arithmos survey, respondents stated that two of the top reasons for not wanting to use eCRFs were technical problems (41.6 per cent) and that it was too time-consuming (22.5 per cent) (4). Improvements in these often highly problematic areas should also be addressed to save time and difficulties among site staff.

Establishing Metrics

Ensuring performance metrics at the start of the trial is also vital in validating study goals, particularly as they apply to EDC systems. It is important to ensure that EDC goals are realistic for each site, and that sites realise that these are guidelines rather than quotas they are required to meet. These target goals for EDC may include:

● Data entry time spent per week (for example, one hour a week)

● Number of queries generated (less than five per subject)

● Data entry turnaround time (maximum five days from site visit)

● Query resolution turnaround time (maximum three days from query generation)

● Time spent on training (minimum eight hours combined); e-learning platform (percentage of training completed versus attempts) and meetings

With concrete goals established and communicated to sites through newsletters and other updates, study teams will become more aware of issues and challenges across sites. In addition, sites can be provided with tips that specifically address these issues.

Tailored Training Curriculums

In order to develop tailored training curriculums, an additional site staff assessment should be conducted, ideally during the early phase of the study (during the kick-off investigator meeting) in order to gauge interest and identify any EDC specific concerns. The aim is to encourage participation and address concerns upfront, which can ultimately help ensure all future training programmes are customised appropriately.

These assessment results can also provide valuable information that can highlight possible EDC challenges that the study team may not have been aware of at this point. This includes asking sites what their potentially demotivating factors are; any concerns they might have with the protocol, CRF and EDC systems; or other issues that could be potential stumbling blocks down the road.

Interactive Education

Particular challenges can also be addressed in an online platform used to enhance and support education for the sites. Most EDC vendors provide general online education programs; however, they are not integrated or tailored to specific protocol or operational issues. A group of testers with varying degrees of experience and skills can help ensure the educational platform is developed so that all levels of competency are met appropriately. For example, the online training may include specific issues such as how to resolve the top-generated queries, case studies on how to complete adverse event and serious adverse event reports, and patient-reported outcome questionnaire compliance tips.

Interactive and innovative face-to-face meetings should also be developed to help engage sites in a unique way to set the study apart. Specifically, the experience with the EDC system should be hands-on, with study-specific screenshots, reports and questionnaires available in as close to final format as possible, so that site staff familiarity is established early on.

Ongoing Communication

Once established, it is important to review and reinforce the educational platform and EDC goals to keep the study top-of- mind. The feedback received on-site and post-meeting can help to guide future meetings and educational material. Trend analysis of this feedback can help to establish specific site problems, and addressing the feedback received in a timely manner – with the help of CRAs and study team members – can help ensure sites feel that their voices are being heard.

Site staff will be increasingly motivated to meet the EDC specific goals, as outlined in the performance metrics, when they are rewarded for their efforts. Sites will feel supported by the enhanced communication through updated site newsletters, web conferences, updated educational modules, and emails addressing particular EDC issues during the trial.

Top Priority

It is Thursday at 4.50pm and Ann has just finished data entry on her computer. She works on the EDC system for 20 minutes a day, as agreed with the sponsor, and this has worked out well. Queries are resolved more quickly and data is kept more top-of-mind. She is ready for the monitoring visit tomorrow since she is up-to-date with her patient data – and has been throughout the trial.

She speaks with her CRA about once a week and has an ease of communication that flows increasingly well. Sometimes working on trials can be tough, but this one is particularly straightforward. She hopes to continue working with the same sponsor and study team, as it is clear that the sites are a top priority.

References

1. Banik N, Evaluation of EDC versus paper in a multinational asthma trial, presented at the DIA European Data Management Meeting in Berlin, 1998

2. Redfearn S, Sites+EDC=Pain, ClinPage, 8th July 2008. Visit: www.clinpage.com/article/sitesedcpain/C5

3. Redfearn S, More paper, more burden? ClinPage, 19th October 2009. Visit: www.clinpage.com/article/more_ paper_more_burden/C11

4. EDC System Usage Survey: How experience improves user satisfaction, 5th June 2013. Visit: http://healthcaretechbuzz. wordpress.com/2013/06

5. Franklin JD, Guidry A and Brinkley JF, A partnership approach for electronic data capture in small-scale clinical trials, Journal of Biomedical Informatics 44(1), S103-S108, 2011


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Caroline Chin has more than nine years of experience working in clinical trials, and over six years as a data manager at a contract research organisation. She is currently a Project Manager at specialist healthcare consulting firm, AXON Communications. Caroline supports clients by providing a unique blend of experience and expertise in medical communications, digital platforms and clinical trial support services to ensure engagement, retention and outreach.

Chuck Johnston, a Partner at AXON, works with clients to develop communication and education strategies to achieve their business objectives. With more than 24 years of experience at senior management positions in healthcare, he has an in-depth understanding of the barriers and motivation required to optimise knowledge transfer and behavioural change. Chuck graduated from Queens’ University with an MSc in Pharmacology.

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