Informed Consent: Contextualised for the contemporary clinical trial

Informed consent is a fundamental component of patient-centric care.

It involves considered and effective physician-patient communication to ensure that clinical trial participants can make decisions in their best interest and in complete awareness of their clinical condition, central to the consenting process sits the Informed Consent Form (ICF) itself.

In a very real way getting the structure and language of the ICF correct can make or break a trial, it signals directly to a patient how a trial sponsor regards them as an individual, hence it is not just a signature on a piece of paper.

Our ambition is to enhance communications with trial participants by refocusing the consent process away from a rigid and defensive “word-salad” information leaflet, towards a more holistic and approachable document that works as intended.

Through language simplification and close attention to the format of presented information, trial participants engage more readily and positively with the clinical trial recruitment process

Consent and the Clinical Trial

Clinical trials are the means by which medical innovations, hypothesis, and assumed knowledge is put to the test- where the rubber meets the road. Unlike a laboratory trial wherein the safety of the scientific staff is often the chief ethical concern, clinical trials take place with real people at the heart of the day-to-day activities and ultimately at the receiving end of any risk. There is a myriad of ethical questions that may be raised by any number of trials, but a foundational concept in the clinical trials industry is informed consent. Informed consent is:

“A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”

...as defined by ICH GCP, agreed upon after the Declaration of Helsinki internationally to prevent abuse in human research after the horrors of the Second World War. A noble definition, but not without challenges.

Have you seen the sticking point?

The definition is necessarily broad in its scope, but “informed of all aspects of the trial that are relevant” is the key component of this definition that can cause endless headaches for both trial Sponsors and participants alike. Our understanding of the human body has exponentially increased in complexity since Informed Consent was defined, and correspondingly so has the difficulty for the average person to appreciate the information that is presented to them.

Sponsors and those responsible for writing the patient-facing materials have responded in kind. To avoid any appearance of deceptive practice or negligently exposing themselves or their companies to liability- the documents provided to clinical trial participants have exploded with information on side effects, mechanisms of action, schedules, and theoretical risks to the nth degree.

The unintended consequence of this is that when a potential participant is given a thirty-page document of dense scientific obscura and legalese the wood is lost for the trees. Much like the license agreement to many an installed app or program on a phone, the most important information is quickly buried and is unlikely to be retained at all by the participant.

Capacity, the silent partner to informed consent

Contracts that are signed and agreed by both sides are fairly standard in every walk of life. If the participant has signed and every bit of information has been included, then where’s the issue?

Capacity.

Capacity is a silent partner to the definition of informed consent. As clinical trials take place within a medical context, capacity is an ever-present consideration and is especially important in seriously unwell participants. Capacity is a concept of a decision maker essentially being of sound mind.

This relies on being able to receive the information, retain the information, and weigh up the information to the extent required to decide. If the information presented to a trial participant requires the understanding of a tenured professor in medicinal biochemistry, then it’s unlikely the average reasonable person could be expected to sincerely engage with vital information.

In a similar fashion, if the text is printed in light grey on the back of a white paper cardstock in a barely legible typeface and provided to the participant it would be extremely charitable judge (or severely apathetic prosecution) that would conclude that the participant had been delivered the information in a suitable and accessible manner.

The unfortunate reality is that whilst most information leaflets provided for trial participants have been written by some of the most accomplished and intelligent members of the medical and scientific community there is a lack of accommodation for the participants themselves. Trial participants come from all walks of life. Every educational background, every learning and behavioural quirk, and every stage of stress and vulnerability are represented.

There’s a degree of empathy that needs to be reinvigorated within the writing process for clinical trials that considers not only how the company scientist and lawyer would like to see the documents written but also the participant. We must ask ourselves what is realistically going to convey the important information to the participant, and sometimes less is more.

In summary, Informed consent is influenced not only by form and content of the information provided to the participant but also the mental faculties of the participant.

Lead with the patients in mind

Don't underestimate the power of shape

People are intensely visual and in the same way that paragraphs break up text to make it easier to read, the placement of graphics and the layout of information spatially can dramatically change how easy the information is to retain.

Lessons learned in other industries such as in print advertisement and graphic design can be used to influence which parts of the document are made easier to read and retain.

Readability can only get you so far

Many sponsors and trial designers employ a low-resolution approach of simply using digital tools to simplify language contained within the participant information leaflet, but many concepts cannot be reduced further than their scientific definition or specific medical meaning.

Lots of work is required with focus grouping and A-B testing to identify the key concepts that are important to participants, and this can lead to some surprising feedback.

You will get as many options as you ask for

Whilst focus group testing can be used to identify common themes and pitfalls across most documents, it’s important to have a leader who understands the problems of information overload but still has insight as to what cannot be lost from the document.

As this process requires the input of many stakeholders, it can easily devolve into a document trying to be all things to all people - the focus must be ease of understanding for the average person. A single voice can help keep the document on track.

We still have a lot to learn

Developing standards for consistently approachable trial information is a very complicated and ultimately multidisciplinary area that will surely undergo evolution as it is adopted more widely across the clinical trials space.

We believe that the development of this work will lead to increased participant retention, reduced trial costs, and most importantly an improvement in the quality of life for all our trial participants who at the end of the day this is all about.