My first encounter with clinical research was as a junior dentist at Al-Sheikh Zayed Al-Nahyan Hospital in Cairo. I conducted several clinical studies to measure the effects of oral and dental diseases in patients in an underdeveloped setting.
I have been struggling with an eating disorder for the past few years. I am afraid to eat and afraid I will gain weight. The fear is unjustified as I was never overweight. I have weighed the same since I was 12 years old, and I am currently nearing my 25th birthday. Yet, when I see my reflection, I see somebody who is much larger than reality.
I told my therapist that I thought I was fat. She said it was 'body dysmorphia'.
She explained this as a mental health condition where a person is apprehensive about their appearance and suggested I visit a nutritionist. She also told me that this condition was associated with other anxiety disorders and eating disorders. I did not understand what she was saying as I was in denial; I had a problem, to begin with. I wanted a solution without having to address my issues.
Upon visiting my nutritionist, he conducted an in-body scan and told me my body weight was dangerously low.
I disagreed with him.
I felt he was speaking about a different person than the person I saw in the mirror. I felt like the elephant in the room- both literally and figuratively. He then made the simple but revolutionary suggestion to keep a food diary to track what I was eating.
This was a clever way for my nutritionist and me to be on the same page. By recording all my meals, drinks, and snacks, I was able to see what I was eating versus what I was supposed to be eating. Keeping a meal diary was a powerful and non-invasive way for my nutritionist to walk in my shoes for a specific time and understand my eating (and thinking) habits.
No other methodology would have allowed my nutritionist to capture so much contextual and behavioural information on my eating patterns other than a daily detailed food diary.
However, by using a paper and pen, I often forgot (or intentionally did not enter my food entries) as I felt guilty reading what I had eaten or that I had eaten at all.
I also did not have the visual flexibility to express myself through using photos, videos, voice recordings, and screen recordings. The usage of multiple media sources would have allowed my nutritionist to observe my behaviour in real-time and gain a holistic view of my physical and emotional needs.
I confessed to my therapist my deliberate dishonesty in completing the physical food diary and why I had been reluctant to participate in the exercise. My therapist then suggested to my nutritionist and me to transition to a mobile diary study.
Whilst I used a physical diary (paper and pen), a mobile diary study app would have helped my nutritionist and me reach a common ground (and to be on the same page) sooner rather than later.
As a millennial, I wanted to feel like journaling was as easy as Tweeting or posting a picture on Instagram. But at the same time, I wanted to know that the information I provided in a digital diary would be as safe and private as it would have been as my handwritten diary locked in my bedroom cabinet.
Further, a digital food diary study platform with push notifications would have served as a constant reminder to log in my food entries as I constantly check my phone. It would have also made the task of writing a food diary less momentous by transforming my journaling into micro-journaling by allowing me to enter one bite at a time rather than the whole day's worth of meals at once.
Mainly, the digital food diary could help collect the evidence that I was not the elephant in the room, but rather that the elephant in the room was my denied eating disorder.
The elephant in the room
I would visit each site with paper forms and collect all of my data with pen and paper. Once a week, I would sit down for hours to transcribe all of the data I had on paper to Excel.
Although my experience doing research data collection sounds like a monumental task, I wasn't alone, and although that was a few years ago, most clinicians doing research still rely on pen and paper.
Electronic Data Capture (EDC) solutions simplify data gathering in clinical research by improving data quality, security and making data collection be as easy as possible. In this article I share 5 EDC platforms that I could have used during my clinical studies to eliminate the burden of paper data collection and embrace the benefits of capturing data digitally.
Electronic Data Capture (EDC) is software for collecting and managing clinical research electronically.
The main benefits of EDCs over paper forms is that they increase the reliability of data by eliminating transcription from paper to database, and they increase data security with automatic backups.
If you are a medical researcher looking for ways to capture data for clinical trials to benefit your research significantly, Electronic Data Capture (EDC) may be your answer.
You are likely to have come across survey software such as Google Forms, Survey Monkey, or Qualtrics.
And you might be thinking: if I want to replace paper forms with digital forms, then can't I use something like Google Forms for my clinical research?
The short answer is, it depends.
In the following cases Google Forms is a suitable platform for collecting clinical research data:
If you are planning to do a clinical study and the 3 cases above are true, then Google forms is a great solution for your data collection, and best of all, it's free.
Although online survey solutions can be a quick step to eradicate paper-based data collection, there are 5 showstoppers.
Below is a table of 5 main points and showstoppers of what separates online surveys from validated EDCs:
If you have read this far, then the main takeaway is that online forms and surveys are used for more general data. At the same time, Electronic Data Capture solutions are more suitable for healthcare and clinical trials.
The following section compares 5 of the most popular EDC platforms to help you, as a researcher, decide the most suitable option for your human research.
EDC platforms are not a one size fits all solution. These platforms come in different packages and flavours. For a researcher to choose the best EDC platform for a project, education on the varieties that exist is key to understanding the subtle nuances between them and selecting the most suitable option.
Teamscope is a data collection platform for research teams that need a secure solution to capture and analyse data.
Teamscope's unique selling point is its easy-to-use Android and iOS app for data entry, which can be particularly useful when working in offline or remote settings. Research teams can also use the web interface to collect data from any browser and build powerful reports and graphs.
Teamscope offers pricing plans for different team sizes and access to various features, depending on the study need. The monthly price ranges from €49/month billed annually to €249/month billed annually. Some of the main differences between each plan are the level of features and the number of users, cases and amount of file storage it includes.
Further, all plans come with a 30-day money-back guarantee and a 7-day free trial.
With Teamscope, research is a collaborative effort. Team management features such as allowing users to edit each other's entries can enhance the user experience by expediting data analysis. This functionality is permitted through a customisable permissions manager that enables the researcher to give predefined functions such as View All, Add Entry, or Export to individual users or groups created.
Another unique feature of Teamscope is the prioritisation of data security and the integration of features to store and protect data, such as the Teamscope Passcode Lock Screen. To unlock the app, users must enter a 4-digit code, thereby adding a layer of security to the sensitive user information on the app.
Teamscope does not offer randomisation, which can be a deal-breaker for randomised control trials (RCT).
The platform also offers minimal data exporting capabilities, only Excel and CSV. No, SPSS or Stata data exporting capabilities.
"Using Teamscope has been a game-changer for me. It has turned the difficult and stressful process of data collection in the field (and being paramedics - a challenging and often chaotic field at that) into a painless process."
Castor EDC is a cloud-based clinical data management platform that enables researchers to capture and integrate data from any source. Data sources include clinicians, patients, devices, wearables and Electronic Health Record (EHR) systems.
Cost is tailored to the needs of a study. Prices vary for non-commercial and commercial studies.
Non-commercial studies carried out by non-profit organisations are free. There is, however, a maximum of 5 free studies per academic institute. Additionally, this does not include custom contracting or extensive compliance validation.
Commercial fees apply in case a commercial organisation is carrying out a study. Fees also apply if the study is funded commercially or non-commercially. Finally, varying commercial fees apply if a study is run by Clinical Trial Units, Clinical Research Facilities, Academic Research Organisations and similar organisations.
Castor's cloud-based EDC system also enables researchers to capture high quality, reusable data easily.
Castor makes the building of studies within hours using pre-built templates and user-friendly technology. Its EDC interface is designed to be intuitive and researcher-friendly.
To help researchers set up their studies, online video training, monthly webinars and prompt customer service facilitate setting up a study. In the case of more complex analyses, Castor assists through study experts.
Castor is tailored specifically for use in large academic, medical device, biotech, and pharmaceutical research. The platform has everything you need to build a study that matches precisely with your study design.
It is a platform that is compliant with patient data privacy laws and Good Clinical Research Practice (GCP).
The EDC data entry is only possible through the web browser, making it dependent on an internet connection.
Castor recently released an ePRO mobile app, which makes it possible for patients to complete surveys from an Android and iOS device without the need for an internet connection.
Castor's new mobile app for patients is exciting news and a sign that the company could be offering a fully mobile and offline experience for their EDC data entry.
"Without Castor EDC, we would never have been able to collect such a large amount of data across all centers with the limited amount of local funding they received. And a paper CRF of this length would certainly not have been manageable."
– Dr De Waele, Ghent University Hospital in Belgium
Smart Trial is a complete data collection toolbox for Post-Market Clinical Follow-Up (PMCF) and clinical investigations. This EDC platform is built to empower clinical teams to be their best and fully control their clinical data without compromising on features, design, or compliance.
Although pricing is not public on the website, they offer a free trial to give a hands-on experience of their solution. For more information on product pricing and custom quotes, email firstname.lastname@example.org
Has ready to use templates, modules, and features that help MedTech companies comply with industry regulations.
Ease of use and customer experience are two of the key selling points. Also, Smart Trial has a valuable feature which is the reuse of forms for all the investigators. This feature allows for the easy scalability of the study for multi-sites and multi-phase trials.
No mobile app is available nor support for offline data collection.
''As a chief investigator, I've found SmartTrials to be an incredibly efficient piece of software. It is intuitive to use for all research team members. The functionality of setting up a trial is very easy to navigate. Being able to view data and troubleshoot when running a multicentre trial remotely is invaluable.''
REDCap is a software solution designed to rapidly develop electronic data capture tools (EDC) to support clinical research.
Academic institutions may use REDCap at no charge but need internal IT staff to support its implementation. REDCap is also limited in redistribution because Vanderbilt University (the multi-institutional consortium that initiated the system) is the sole distributor.
If you are in academia, there is a high chance that your organisation is part of the REDcap consortium, and you may be able to use it for your clinical study.
The security and web-based feature of REDCap allows users to input data from anywhere globally with secure web authentication, data logging, and Secure Sockets Layer (SSL)
Secure Socket Layer (SSL) provides security to the transferred data between web browser and server. SSL encrypt the link between a web server and a browser which ensures that all data passed between them remain private and free from attack.
Multi-site access enables the researcher to use projects from multiple sites and multiple institutions.
REDCap is free and web-based. It allows for databases to be quickly developed and customised for studies' needs.
REDCap is a widely used EDC in the academic research community. The REDcap consortium has more than 2400 institutional partners using the software for more than 450,000 research studies.
Technological knowledge is required for the usage of REDcap. Using the REDcap web interface is easy but getting started requires your research organisation to have a specific infrastructure (e.g. PHP web server, MySQL database server) and the technical expertise to install the software on a web server.
Technical support provided to users by REDCap is subject to each organisation. The REDcap software is provided for free by the University of Vanderbilt, but each institution is responsible for providing support to users.
"It (REDCap) is relatively easy to use once you get the hang of how it works. The commands are relatively straightforward, with nothing too involved or complex. It is reliable, and I have been using it over the course of a few years. Overall, it is a good way to keep information organized in a way that makes it easy to look up. I work with a patient information database that I need to pull information from and put data into regularly. It has helped me locate records with ease to have access to the information as soon as I need it."
Brittany Ann S
Medrio is a cloud-hosted eClinical platform that empowers researchers to accelerate their clinical trials, reduce study costs, and bring life-saving products to market. This EDC platform is tailor-made for pharma, biotech, animal health, medical devices, and diagnostic studies.
Cost is provided by the vendor through scheduling a demo https://medrio.com/request-demo/; however, the website states that the price is 63% lower than two other large EDC providers.
Data on the Medrio software is easy to share, download, and view even with unfamiliar programming and database structures.
Allows users to control the setup, programming, launch and administration of the databases themselves. This advantage enables considerable savings in terms of time and cost. The platform is user friendly. Most of the training needed is on the study-building end, but for the data entry personnel (study sites), Medrio can be used quickly and easily. Further, the customer service is helpful and accommodating to client needs.
Due to this EDC system being user-friendly, it lacks some of the bells and whistles that other EDC systems have. These features include complex custom function query logic and dynamic search list fields. Additionally, the server latency can be improved for this software.
''I have done about twenty clinical studies with Medrio. It is easy to configure a study, design the forms, and deploy. If mid-study changes are required, they are easy to accomplish in Medrio''.
Clinical Data Analyst
Online forms such as Google forms are excellent and free tools for collecting general data such as data on user experience.
5 main differences between online forms and EDCs are:
If you deal with human research where more advanced features are required, such as case management, data privacy, and sensitive data, your best bet is an EDC.
5 of the best EDCs to consider are as follows depending on the needs of your study:
Traditional EDC systems are not one-size-fits-all. While this article compares five of the best and most commonly used EDC systems highlighting their features, many more EDC systems are available.
There are no perfect EDC systems. There will always be missing features, and a great EDC will always be a work in progress. Concerning that, if you are a researcher, you must keep sharing feature requests with EDC developers through honest reviews and contacting support teams. This feedback ensures that your recommendations are taken into account by developers for further software enhancement.
Until then, while choosing your EDC system, do your homework to find the most suitable option for your research. Most of them offer a free demo or a call with their team where you can share your study design and if their tools are indeed the best fit for the kind of research you have in mind.
If appropriately used in the 21st century, data could save us from lots of failed interventions and enable us to provide evidence-based solutions towards tackling malaria globally. This is also part of what makes the ALMA scorecard generated by the African Leaders Malaria Alliance an essential tool for tracking malaria intervention globally.
If we are able to know the financial resources deployed to fight malaria in an endemic country and equate it to the coverage and impact, it would be easier to strengthen accountability for malaria control and also track progress in malaria elimination across the continent of Africa and beyond.
West African Lead, ALMA Youth Advisory Council/Zero Malaria Champion
Build fully customizable data capture forms, collect data wherever you are and analyze it with a few clicks — without any training required.
Build customisable mobile forms, create flexible reminders and invite participants with a few clicks — without any training required.
Dear Digital Diary,
I realized that there is an unquestionable comfort in being misunderstood. For to be understood, one must peel off all the emotional layers and be exposed.
This requires both vulnerability and strength. I guess by using a physical diary (a paper and a pen), I never felt like what I was saying was analyzed or judged. But I also never thought I was understood.
Paper does not talk back.Using a daily digital diary has required emotional strength. It has required the need to trust and the need to provide information to be helped and understood.
Using a daily diary has needed less time and effort than a physical diary as I am prompted to interact through mobile notifications. I also no longer relay information from memory, but rather the medical or personal insights I enter are real-time behaviours and experiences.
The interaction is more organic. I also must confess this technology has allowed me to see patterns in my behaviour that I would have otherwise never noticed. I trust that the data I enter is safe as it is password protected. I also trust that I am safe because my doctor and nutritionist can view my records in real-time.
Also, with the data entered being more objective and diverse through pictures and voice recordings, my treatment plan has been better suited to my needs.
No more elephants in this room