Besides working in Clinical Trial technologies, I also have an interest in tackling issues around global warming. Electronic Data Capture in clinical trials has the advantage in that it inherently lends itself towards tackling many of the issues that contribute towards global warming. I am interested in both the benefits that can be achieved during the implementation cycle, as well as the value during the execution phase.
Green EDC does make a lot of sense from many perspectives. In almost all instances, working with an electronic medium is considerably faster than working with paper. This leads to a reduction in cycle times, and lower costs. You can basically ‘do more with less’.
Using technology today
Probably the most obvious one.
Large, expensive Investigator Meetings were common until only a few years ago. Changes in rules and attitudes have ensured they have become more functional rather than an investigator incentive. As a result, unnecessary travel has been reduced. However, are investigator meetings actually required?
From the EDC perspective, training is often provided during the course of the meeting. This can take up as much as half the time spent.
eLearning solutions, available from many of the EDC vendors, should alleviate the need for Investigator meeting training. At most, you might be looking at a short demonstration. If eLearning is implemented well, it has many advantages over traditional instructor led training. It should be integrated into the product, it should be integrated into the workflow, and, it should adaptable to meet the changing training requirements from study to study.
Integration is important. The early eLearning solutions were often implemented as separate tools. You would be provided a separate login to access the eLearning – you almost had to learn to operate the eLearning tool! With fully integrated eLearning inside EDC, the EDC system login directs trainee through appropriate eLearning topics based on the role they have been assigned to, before they can participate in the study. Participation and test results are all logged ensuring an electronic record is maintained for process compliance. Another advantage of eLearning is the ability to train new staff prior to Monitoring visits. In the past, a new study nurse for example had to wait until potentially the Monitors next site visit. With eLearning, they simply await a login, perform the eLearning and they are ready to participate.
Less Monitoring Visits
Besides the removal of the need for monitors to attend sites regularly for staff training, the overall number of Monitoring visits should be reduced with effective use of EDC systems themselves. Monitors are increasingly taking the role of the Data Manager in carrying out the duties of data review over and above the cleaning functions of the study build itself. Source Data Verification remains necessary, but the actual Q & A regarding the data itself can be carried out remotely. Less Monitoring visits means typically less air-travel.
This seems obvious – we are talking about replacing paper with an electronic medium – however, we also have paper flows in other areas of the process. The development of the EDC product itself together with the implementation phase of the system for a study often involves the preparation of many binders of paper materials designed to support a vendor (or regulatory) audit. Despite the electronic nature of the solutions that EDC companies provide, very few companies effectively push a paper development and implementation process. The use of electronic document management systems are beginning to change this, but, it does require the support of Quality Assurance and Regulatory groups who tend to be more comfortable with a large pile of paper binders and wet ink signatures than fully electronic systems.
Widely used standards for document signatures are currently a barrier. The SAFE BioPharma Association have had some success in offering up a electronic document signing solution that could be used across the industry, but it still has some challenges related to Hardware and Technology dependency. We may see progress following SAFE’s partnership with CDISC.
Paper itself is not that ‘non-green’, but the delivery of paper can be. Organizations involved in clinical trials today are often global. Fedex’ing a CRF, a specification or a submission in paper format is simply not necessary with technology available today.
Messaging and Video Conferencing
Is it not odd that a technology such as video conference has such limited use in business today, and yet teenagers all round the global use it regularly to chat with their friends over the internet?
Some EDC systems make use of tools to provide interactive support, but they are often poor.
If I am using an Internet application – such as banking or the like, and I have a problem, I would like to chat – by keyboard or over the phone – immediately. Messenger services either inside, or outside of the EDC application are available today. I have yet to see a good implementation of interactive support within the tool. [I am sure EDC vendors that already have such services built in will correct me here!]
By offering interactive support and communication tools within an EDC product, site personnel can achieve equivalent, or potentially better support than can be achieved through infrequent monitoring visits.
So, what can we still do to improve our green credentials when carrying out clinical trials?
Applying standards, can improve overall efficiencies.
Since 2004, SDTM, the Submission Data Tabulation Model from CDISC is part of a move to a standard electronic medium for data submissions. The electronic submission of course is not new, but the standardization of the format is new making it somewhat easier for regulatory bodies to process data received regardless of the source. Standard outputs require standard inputs, so with the recent introduction of CDASH – Clinical Data Acquisition Standards Harmonization– a standardization of the input structures in clinical trials – the overall SDTM production process should become less onerous.
Downstream from EDC, we have the eCTD – electronic Common Technical Document an interface for the pharmaceutical industry to agency transfer of regulatory information. From 1/1/2008, this is a required format (barring a waiver) by the FDA and has/will result in a great reduction in the amount of paper delivered to regulatory authorities.
Trial Execution Efficiency
Both Adaptive Clinical trials as well as non adaptive studies where a Bayesian continual reassessment method (CRM) is taken, can help ensure that unnecessary trial execution work is avoided. In the past, trials tended to be more serial in nature – complete study A before moving onto Study B. With the ability to adjust the design, and, more commonly, the ability to examine data subsets early in the trial, either an early termination or a change of focus can be made saving time, money and of course our impact on the environment.
Source Data Verification
Going back to my eBanking analogy, if I want to record a payment transaction into my eBanking solution, I do not write it down on paper first, and then transcribe what I write down into the eBanking transaction form. There is no value in that.
In clinical trials, if an investigator is involved in a clinical trial where the subject responds to questions during data entry, it would make sense to in certain circumstances to enter these directly into the EDC system, and not on paper first – as source date – this would avoid potential transcription errors.
But no….The interpretation of guidelines regarding Source Data typically means that web based systems cannot be used to retain the ‘Source Data’. I personally have an issue with this interpretation, but I will not elaborate here. It is indicated that the ‘Source Data’ must remain at the site. Web based systems do not hold data onsite, but instead hold the data on a central server. [Dave Iberson-Hirst from CDISC provided a good description of the challenges of Source data in his article in Applied Clinical Trials focusing on electronic Patient Diaries – for the sake of brevity, I have summarized the points of argument.]
Workarounds have involved the use of an offline, or hybrid system where the data is stored on a local device at the site. More commonly though, data is recorded on paper first, and then transcribed into the electronic CRF. Admittedly, a lot of source data will come from Medical records, and other paper records, however, it seems rather regressive that due to the wording of a regulation, more data is captured on paper first for web based systems that the old fashion Remote Data Entry tools. Hopefully improved guidance in the near future will avoid this.
I am a great believer that being ‘Green’ means being efficient in business. Reducing the inefficiencies in how we go about our work not only offers savings in time and money, it can also have a positive impact on our environment. Here’s to an electronic clinical world!