![5 Steps For Effective Trial Design and Improved Compliance]()
This blog post will address a number of elements which are important for overcoming some of the challenges faced in clinical trials – whether it’s pharmaceutical, medical devices, or public research.
Subject recruitment, quality of data, compliance, and participants’ safety are only among the few challenges to overcome when designing and conducting clinical trials. Accordingly, I have summarized the key points to start focusing on in order to improve.
1. Start at the end
A study from Berendt and colleagues illustrates that there are high inconsistencies between submitted study protocols and their corresponding published reports. This indicates that there’s clearly something wrong with how we conduct protocol design, and even worse, it places a question mark on the validity of the data published.
In order to overcome this inconsistency, we must place more focus on what we want to accomplish, i.e. how we would like our data to be presented and which parameters we want to highlight (e.g. endpoints).
Electronic case report forms, patient-reported outcomes, and other forms and data inputs must be placed relatively high on the to-do list, and the methods or choice of technology used to collect the data must be solid. Have you ever tried designing your data collection forms before anything else?
FREE DEMO: Click here to see how you can streamline the collection and management of clinical data to bring safer and better medical devices to patients.
2. Focus on all your participants
The subjects aren’t the only people participating in a clinical trial. There’s a whole range of people involved, from subject relatives to investigators, monitors, sponsors, and laboratory personnel. We must acknowledge the fact that our trial is only as strong as our weakest link.
If all participants don't have clearly defined roles, aren’t well informed, or even allowed to make remarks to the study process itself, things can go sideways very quickly. Remember that investigators, or other trial personnel, aren’t the only people that have to learn or be trained, we must also include the subjects themselves in all information flows.
3. Broader engagement
If we are to set more focus on participants, we must broaden their engagement. I believe that giving feedback to both subjects and their relatives during the course of a trial and providing a more personalized experience to each subject can be golden for improving compliance.
If we can manage to continuously inform our subjects of their current status or progress, or even give them a chance to learn something along the way, we might even have more satisfied people involved in the study. This does not only apply to subjects and their relatives.
This must also be applied to all other personnel. Giving feedback on performance, full status of study compliance, data collection, or other information of interest, can be vital for keeping everyone committed to perform and reach the pre-defined trial goals.
4. Explain the why
I cannot emphasize this enough, the importance of communicating the 'why'. All trials have a 'why' to them, sadly this is often not mediated well enough. The why is not the school book definition of a phase-1,-2, or -3 clinical trial – The why is the bigger picture, the perfect outcome of every trial - a new method, device, or medicine, which can help us improve health or provide better healthcare treatment.
Explaining the 'why' to everyone, i.e. the actual reason for why the trial is being conducted and the possible benefits of its results is much more interesting and giving. I believe that as soon as everyone is set on the 'why' we can achieve not only improved compliance but higher quality of data as well – because everyone is set on the goal, to provide results for the greater good.
5. Utilize methods from other markets
It’s amazing how much modern technology is yet to be applied in healthcare. Yes, the healthcare industry contains many of the most sophisticated technologies available in many areas, however, we aren’t fully utilizing all of the possibilities available to us.
We are living in the age of social media, and information flow throughout the internet is enormous. Why aren’t we utilizing this more for empowering participants? Other markets are already using multiple platforms and technologies available for sharing information, engaging people, and marketing (recruitment).
I believe that if we start utilizing more of the technology we already use in our day to day lives, like social media, video platforms, smartphones, or other well-known mediums, we can engage people in a different way, and even have them cooperate better (improved compliance).
For example, would an online social media group be a bad idea, for general information sharing in a particular clinical trial? Read more on how to design better eCRFs and improve your participant's compliance.
6. Design better forms
We don’t gain anything by electrifying paper. Paper and electronic systems, or electronic case report forms (eCRF) and electronic patient reported outcomes (ePRO) look and work differently. By copying the paper or analogous forms, we neglect the advantages of the digital solution.
We need to collect more quantifiable data. Quantifiable data is important when applying statistical methods to collect data. But people often end up collecting a lot of free text and other misleading data that doesn’t really help.
An eCRF is not an EHR! By designing better forms that control the workflow, and guide people through the ‘fill out’ process, you’ll achieve improved compliance and less misleading data.
Users will not have to wonder if certain fields are relevant or not, and won't be shown information that is irrelevant. This last action ended up becoming an inspiration for our eBook on how to design an eCRF.
Gains for Medical Device Manufacturers
From this case study we can conclude that the client has now managed to optimize the overall process - far better than imagined. Firstly, they've cut down on time spent in planning for clinical investigation, from weeks (and sometimes months) to days.
They have managed to save at least 2 hours of work for each subject, only in relation to paperwork, i.e. transcription, printing, and etc. Not to mention, improved data and status overview, cooperation, and data security. Storage of clinical evidence is also safe and fail-proof, and easily accessible, which allows them to gain access to any of the clinical investigation data if required.
FREE DEMO: Click here to see how you can streamline the collection and management of clinical data to bring safer and better medical devices to patients.
Get Greenlight Guru Clinical on Board for Faster Trials
Having supported more than 400 studies from medical device companies all over the world, we can say we have seen it all. Whether it’s advice and guidance on the best practices of collecting clinical data in a trial setting, or orientation on study design from our partners, we got your back.
Greenlight Guru Clinical is one of the top data collection and management methods in the MedTech industry. As a best-in-class electronic data capture solution built for medical devices and IVDs, SMART-TRIAL by Greenlight Guru is the right partner to accelerate your clinical trials and ensure compliance with regulations.
Our electronic data capture (EDC) solution supports medical device manufacturers with their pre- and post-market activities/studies by ensuring the collection and management of high quality clinical data. If you’re ready to learn how we can accelerate your go-to-market process or help you comply with post-market surveillance requirements, book a personalized demo.
