Participant materials as education across the trial
Educating clinical trial participants runs from recruitment, through informed consent, to retention until the end of the study. Effective education can support timely recruitment, compliance and retention, and all content for participants, together with every update to it, answers to the same ethical constraints and the same ethics committee review.
The operational value of participant education
Effective education of potential and enrolled participants can positively influence the key factors in a trial's completion and success. Those factors are timely recruitment of participants, compliance with study procedures, study drug and scheduled visits, and retention of enough participants throughout the study to meet the sample size and power requirements. Clinical trials are hugely expensive and often lengthy, so it is important to be as efficient as possible to avoid cost and time creep. For pre-approval trials, poor recruitment and retention can also substantially delay the authorisation and availability of new treatments.
In a study of 125 people with cancer, greater knowledge and understanding of the trial were associated with consenting to participate, even after accounting for other demographic factors. In a global survey of 5,701 people, 35% of those who dropped out found the informed consent form difficult to understand.
Ethics review and amendment of participant materials
Developing content for clinical trial participants is subject to stringent ethical considerations. Under Good Clinical Practice guidelines, all written information provided to trial participants and potential participants must not be coercive and requires review and approval by an independent ethics committee or institutional review board. In practical terms, that means rounds of review and amendment in addition to the sponsor's own.
A trial protocol is not uncommonly updated even after start-up, and updates affecting participant materials must be made and re-routed through the ethics committee or review board. So the cycle of amendment, review and re-review, with the reprinting or re-programming that follows, can be prolonged. Tracking the version number and date of the document in a footnote is advantageous.
Education at recruitment and consent
At recruitment, the main educational goals for potential participants include informing them fully about the study and ensuring that they understand the information. These goals are achieved through the informed consent process, which involves providing written information, which should also be explained to the patient, and signing a consent form. Where participants require a legally acceptable representative to give consent, such as children or patients with cognitive impairment, they should nevertheless be informed about the trial to an extent compatible with their understanding. If capable, the participant should assent and sign and personally date an assent form. The Declaration of Helsinki, the origin of the ethical principles of current international guidelines, requires that all participants have knowledge and perceived understanding of all relevant aspects of the trial. All communications must also be factual and not persuasive, whether about agreeing to participate or, later, about remaining in the study.
Despite the guidance, many studies show insufficient knowledge and understanding among participants, which is both an ethical and a legal concern and can also impair recruitment. In drafting educational content for trial participants, it can be useful to consider the reasons why people may not take part in clinical trials. The commonly cited reasons for taking part and for not taking part are these:
| Common reasons for participation | Common reasons for non-participation |
|---|---|
| Perception of personal gain, of receiving better care and extra attention, through participation | Perception of personal risk and fear, such as of the experimental nature, adverse events and study procedures |
| Possible eventual benefits to others, altruism, especially for future generations of family or when a cure for one's own condition is unlikely | Concern about potentially receiving a placebo |
| Gaining access to healthcare, for example for US individuals with no health insurance | Financial cost, for example travel, unpaid time off work and childcare cost |
| Access to new treatments | Time commitment: the number or duration of study centre visits, the study duration, a requirement for diaries or questionnaires |
| Feeling of control in one's own care | Perceived or real impact on a carer: financial or time costs, emotional burden |
| Inadequate communication: lack of understanding, misconceptions, unanswered questions and uncertainty |
Interventions that help people overcome barriers to participation, for participants and their carers where appropriate, most commonly involve tools that support the informed consent conversation or printed educational materials. More personalised and interactive interventions are also worth considering, to address specific barriers to participation and to check understanding. Examples are supplementing the informed consent process with non-clinical lay staff who provide participant education and logistic and emotional support, and personalising the informed consent conversation so that individuals receive the information they want or need.
Informed consent is a process of information exchange that can include both written and visual materials. Visual aids can include a graphic illustration used in discussions between patient and doctor, and short videos that explain the purpose of a specific clinical trial or describe the procedures involved. In 2016, electronic informed consent was becoming more commonplace, with the aim of increasing retention and comprehension of the information. It uses electronic media, such as text, graphics, audio, video, podcasts, interactive websites, biological recognition devices and card readers, to convey information about the study and to obtain and document informed consent. Videos and animation, for example, could be considered to aid understanding in populations with reduced understanding, such as young children. Sometimes, short tests may be used to check participants' understanding.
Education throughout the study
Once a person has decided to take part in a clinical study, it is important to support them throughout the study. Particularly in a study of long duration, educational and engagement efforts should ideally continue throughout, to support retention of participants. Depending on the needs of the participant population and the specifics of the study, they may take the form of a comprehensive multi-channel participant support and communications programme, or a simple automated text messaging service that sends motivational, informational or reminder messages at set points in time. Either way, the same constraints and ethical considerations apply to all content for participants throughout the study as at recruitment. Over a prolonged study, it is useful to measure the effectiveness of the activities and adjust the programme as necessary.