Simplicity may be difficult, but it’s worth pursuing. Informed consent is a great example. Over time, the patient information sheets anchoring the informed consent process have grown in length and complexity to the point where they have become difficult to comprehend and time-consuming to complete. The process is also challenging for sites, which are responsible for managing patient interaction and ensuring documents are completed appropriately and available for regulatory inspections.
Miguel Orri’s authoritative whitepaper on electronic informed consent (eICF) for clinical trials makes an important point in this regard: multimedia is the key. Research shows patients retain information better when it is presented in the form of video, linked PDFs, Q&As, via avatars and in other ways that require interaction.
To further that point, the Clinpal team believes a flexible, cloud-based solution is also key – not just because it can deliver multimedia-formatted information to patients at home, but because it can also save money and time, and keep patients more engaged, thus preventing dropouts.
Consider an interesting early finding from the Verkko study , which is rapidly becoming a landmark event because of its success as a remote trial. Even early on, results indicated Verkko patients were more compliant when compared to a sister trial that was more ‘traditional’ and which included 1-on-1 coaching at the study site. I find it remarkable that multimedia outperformed 1-on-1 coaching, but there it is. I believe the increased compliance is driven by patients’ better understanding of the rather complex profiling protocol used in the study. I also believe the superior results are due to the fact that patients can study this information at home, where they have more time and fewer distractions.
Remote and digital delivery of the core content to the patient has the added benefit of saving significant time. A typical pre-screening visit takes at least 30 minutes of investigator time. This time is typically not compensated by the sponsor and often has a discouraging effect on patients, who too-often decide against taking part. These problems can be avoided by virtually explaining studies before patients come in for the visit: Patients arrive more informed and engaged, sponsors save time and money.
This is not to say ‘in-person’ engagement should be abandoned. Personal engagement is a GCP requirement to ensure patients can ask questions of investigators. However, this engagement can be also digitalized to some extent, enabling patients to ask questions and receive responses in advance of the study visit.
Also very importantly, electronic systems like our Clinpal solution can track time the patients spend on reading the information and can tell sponsors whether the resource was accessed. This is key information that can be used to refine the presentation of the information, its composition and, ultimately, help determine whether patients are truly engaged and informed.
Thus, delivering study information to patients via multimedia channels should be the first part of the process. The costs are lower and the rewards are higher in terms of patient understanding, compliance and speed of the trial and efficiency.
Ah, but what about the signature?
Capturing the patient signatures in a way that truly confirms they understand the study and consent gets a bit more complicated. Because a key issue is verifying patient identification, it is easiest to do this in person and it may be a good idea to add a study visit for this purpose. For some studies, such as very large observational trials with very low risk profiles, it can be acceptable to do this part remotely as well. That’s how we handled it in our Verkko study and it was well received by the ethics committees and patients themselves.
In some regions it’s also feasible to achieve strong identification of the patient remotely – by, for example, using banking access keys (everyone in Finland has one) or with strong mobile identification services. In some countries biometric identification cards can be used. However, a single, globally feasible solution doesn’t exist yet.
Assuming patients do visit the physical trial site, they can provide a signature then, on that old-fashioned but universally accepted communication device, paper. Signatures can then be scanned and uploaded to a central electronic system like Clinpal so that they can be remotely inspected as necessary. One solution, which brings the best of both worlds without added cost and complexity, is a hybrid, or ‘electronic-assisted’ informed consent. With this method, patients can learn about the details of the study at home, but complete the signatures on paper during their first visit. The forms are then scanned and uploaded into Clinpal, where they can be monitored.
However, as of today, the most common electronic approach is to deploy and use tablets at the site. While tablets can prevent the need for scanning and uploading, this solution is not without cost and increased complexity: Sites must buy and maintain the hardware and support the patients in using it. Tablets also require connectivity, either by connecting to the site’s Wi-Fi or by having a SIM card with data access. However, connecting to a site’s Wi-Fi network is often quite complicated because they are protected. Thus many studies revert to paper.
Another factor is that sponsors need to be able to inspect the signed forms remotely, which is next to impossible if the process is entirely paper-based. Keeping in mind that sponsors must be blinded to the signatures and any other free-text information coming from the patient, Clinpal provides role-based classification of data. All free-text data coming from the patient is classified as Protected Health Information (PHI) and automatically blinded from sponsor users. While sponsor users can see that data is present, they can’t view the details. Others who need to verify the completeness of the forms can do so.
One of the key principles we’ve built into Clinpal from the start was to make sure it is flexible and can implement different workflows depending on study needs. The system itself doesn’t limit sponsors in implementing any of the abovementioned methods depending on each study’s requirements.
Conclusion: A flexible platform is key to efficiency and patient satisfaction
Study sponsors should choose a flexible platform that can support a variety of options so that the most suitable can be selected for each case. Technical complexity should also be avoided if possible. The keys are operational simplicity for the sites, the right technical approach for the sponsor and patient-centric implementation of the content and process.
To find out how Clinpal utilizes eICF in clinical trials please contact our team at info@clinpal.com or visit the Contact Us section