Clinical trials can be aided by data capturePreviously, DCC brought you a summary of the pain points one must overcome during the clinical trial process along with our take on how to effectively alleviate such difficulties. Our summary was focussed on the data collection side of a clinical trial, touching on points such as collecting data via the Clinical Report Forms (CRF), reading and interpreting CRFs as well as maintaining consistency, amending data and dealing with certain types of data.

Now it’s time for us to look at the other side of data management, analysis and presentation –forming useful insights from your tests…

We at DCC do not come from a medical background, but we do have a passion for clinical trials and medical research. We are passionate about sharing best practise techniques regarding the collection, automation, analysis and visualisation of data, and we understand that doctors and researchers are extremely passionate about studying their specialist fields in order to provide the best results. Consequently, here at DCC we utilise our passion for data research in order to help medical professionals realise their passion for results.

DCC has recently attended various events such as the UK Stroke Forum and the King’s Fund. From these events we were able to understand the pain points of researchers, doctors and nurses, look into our tool kit and begin customising solutions that will help to alleviate any clinical trial and research project teething pains in future.

While we may not fully understand the processes medical side of a clinical trial from the point of view of a healthcare professional, we do understand data capture and management. Take a look at how our knowledge of the data processes involved in clinical trials can help you in future…

Making sense of data

By listening to various speakers, attending events and watching presentations, we have paid close attention to the methods of data collection and analysis in clinical trials.

The data subject to analysis can be of a qualitative or quantitative nature. Quantitative data, represented in the form of bar graphs and pie charts, is often used for the purposes of comparison – for example comparing the data of patients A and B. Quantitative data is also used for scores, such as risk scores, to identify the risk of a particular phenomenon.

Qualitative analysis is largely based on manual interpretation and the use of thematic analysis. Thematic analysis is the process of reading paragraphs of free text, then re-reading the same text to identify common patterns and themes that emerge via coding. The next step is to place all free text in those themes and to make any cross linkages between themes, where appropriate. One point that it is important to highlight is the difference between codes and themes. A code is a subject and a theme is an opinion within the subject – for example, a code may be ‘staff’ and a theme may be ‘staff were overstretched.’ Thematic analysis goes through

systematic processes of identifying codes and themes, while additionally, reflexivity journals are produced that take into consideration interpreter bias, values and judgement.

Acting upon the data

Those who are in charge of clinical trials are also responsible for the accuracy of the data and implementing a correct, in-depth method of analysis. In addition, these individuals must report the findings to their peers and those in their professional networks. It is important to gain findings that can answer an underlying research question, a part of the question, facilitate future research or key purposes of a clinical trial or even to confirm that a certain theory or idea is baseless, hence no further research is required.

Offering a helping hand

Having previously worked with York Clinical Trials and Liverpool School of Tropical Medicine, we have gradually increased our understanding of clinical trials and can now present several methods that will enhance data quality and analysis.

Data automation

Automating the capture of data from CRFs onto a desired registry or system will ensure that no time is spent manually entering the data onto the database and that data will be 100% accurate, thanks to the removal of human error. It may be beneficial to have electronic versions of the CRFs that can be hosted on a tablet or mobile device, helping to maintain data accuracy and expedite completion and distribution.

Business rules and validations allow fields where participants fill in details to be programmed into accepting only certain types of data and formatting. For example number / letter only fields, date fields and fields that only accept / exclude certain lengths and types of characters. Rules and validations can programme questions that are only to be filled out by certain people, i.e. male and female only questions, questions for specific age groups, conditions, medication and so forth. The business rules and validations come into effect whilst CRFs are being scanned in the verification stages. However, they are always ‘live’ on online CRFs and flag up errors upon incorrect submission attempts.

Workflows help determine the path of a CRF. Various trials that involve participants from different backgrounds (medically, socially, demographically etc.) and these may need to be separated for the analysis stage. The implementation of a workflow system will allow the pathway of each individual CRF to be formulated based on the programming of the workflow.

Data analysis and representation

Qualitative (free text) data will largely consist of feedback from patients and participants and will involve the emotions they are feeling. Thematic analysis is useful, though time consuming,

and as we mentioned earlier may contain interpreter bias. Text and sentiment analytics is able to give a sentimental and emotional rating to feedback and link associated words to bring you the overall view of a patient but also their opinion on individual factors, providing you with clear, easily decipherable qualitative data.

Representation of the data on a dynamic interactive dashboard displays all vital data on a single screen interface and relevant patterns and correlations. The only difference being that our dashboard is dynamic and interactive – you can feed it large amounts of data and customise as and how you want.

If you would like to learn more, give us a call on 0208 903 5432 or email at info@documentcapture.co.uk and we will be more than happy to share our experience, views and expertise with you using live examples and visuals of how we helped past research projects come to fruition.

Alternatively, if you have a specific project in mind then a free educational knowledge share workshop may be better suited to your needs. The workshop can be held at your premises and it gives us the opportunity to learn more about your project and guide and advise you in the right direction.

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