A clinical trial can’t begin without first obtaining patient consent. Sponsors are responsible for ensuring that all participants understand the protocol, its implications and potential risks: anything that may impact a patient’s willingness to freely participate. If they fail to do so, a sponsor may risk costly delays, compromised results and even litigation. But when it comes to complex medical procedures and implications, explaining trials to patients in a way they can comprehend poses a challenge for sponsors.
Traditional paper-based informed consent forms (ICFs), for example, can be long and complex. But taking ICFs to a digital platform gives sponsors the opportunity to make the consent process more accessible, interactive and reliable. While many sponsors are turning paper consent forms into electronically signable PDFs, experts argue that this isn’t going far enough.
Consent to begin
“Informed consent documents are created to explain to a patient how a trial is going to be run, what they can expect, and the associated risks and potential benefits,” says Jill Balcerzak, Vice President of Global Solutions at content and translations solution provider RWS. “The physical consent is the patient agreeing that they’ve read and understood the material and are voluntarily choosing to participate.”
The content found in these documents often describes technical medical conditions or complex procedures that may not be familiar to its audience, depending on their education level, age or country they reside in. In response to this challenge, regulatory bodies are applying increasing pressure to ensure that patient-facing information can be easily understood by patients.
What’s more, consent documents tend to be long due to all the required information, making it difficult to guarantee that a prospective participant has read it all the way through. The result? The patient may not be fully prepared for what they are consenting to, which may lead to decreased adherence and patient retention through the course of the trial.
Freed from the restrictions of paper form, electronic consent creates the opportunity for more interactivity and reader comprehension. For example, eConsent could include photos, videos and scrollable text. Links to videos or hover-over text explanations can also be used to clarify technical terminology for those who need it, without adding clutter to the main content. And, as US and European regulation around accessibility becomes more stringent, eConsent can be equipped with capabilities like voiceover and video transcription.
Beyond that, eConsent can integrate into a broader digital ecosystem, which unlocks valuable opportunities for automation, cost reducion and time savings, Balcerzak explains: “For pharmaceutical companies, eConsent lowers their risk because they can educate the patient better and ulimately retain the patient throughout the trial process.
“When a patient pre-screens online, automation can push the eConsent to those who qualify. Now they’re engaging and interacting in real-time. With that comes significant time savings because it’s automated. If the patient ends up getting chosen to participate in the trial, further trial inputs and information can be pushed from this same ecosystem to manage the clinical trial itself.
“A lot of manual effort is removed, and it all starts with eConsent.”
Getting it right
Transitioning to eConsent can be of great value to sponsors, but it is important to get it right – and it starts with the content itself.
“RWS can ensure the source ICF is written in a way that can be understood by a fifth-grade reading level. We call this quality at source. As part of our new content authoring service, RWS can write the ICFs on your behalf or review them in advance of globalisation,” says Balcerzak.
“There are also other localisation considerations. For example, if there are instructional photos or videos, are they right for the target audience?”
RWS has the internal capabilities to check content for accessibility and call attention to things that might not be easily understood by the target population. “The general population is demanding this, and it can be hard execute,” says Alisa Heinzman, eCOA solutions manager at RWS. “We have a team that can run accessibility testing against different organisational standards.”
The future of consent
“I think paper consent will eventually go away, and eConsent solutions will become more sophisticated,” says Balcerzak. “Right now, some clients are simply taking paper consents and converting them into an electronically signable PDFs. That’s not enhancing the patient experience. The next generation is moving the content to an interactive method of administration.
“It’s going to evolve to become more interactive, more accessible, more graphical, more multi-media,” Balcerzak predicts, all in an effort to increase patient comprehension. “RWS already has the proven methodology and experience,” she concludes. “As the marketplace becomes more mature, we’re here to bring our expertise to the table while guiding you through this next generation process.”
To find out more about how RWS can help improve your clinical trial documentation, download the whitepaper below.