Engaging Populations in Clinical Trials

By Grace Plahe, BScReviewed by Emily Henderson, B.Sc.

Introduction
Improving Patient Experience
Eligibility Criteria for Clinical Trials
Clear Communication Surrounding Clinical Trials
Moving Forwards
References

The public's engagement with clinical trials has been a long-standing part of scientific research. Although it is an essential part of the process, increasing public engagement in these trials is still a challenge. This is due to many factors, not least of all because traditionally, research is seen to be carried out on the public rather than with or by them.

The overly impersonal approach to clinical trials has made the public distrustful and wary of them. Still, the move towards more tailored patient experiences promises to include the participants more and hopefully improve trial participation. Although this is becoming more commonplace in healthcare, it is not as popular in research trials.

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Improving Patient Experience

Different aspects of the process must be addressed to improve the patients' experience when participating in research trials and increase participation. Six key areas need to be addressed to improve the process and engage the public.

The most important point to consider is if this research will be relevant to the individuals taking part in the trial. The project's priorities may be scientifically important but not significant to the participants. To combat this, organizations such as the patient-centered outcomes research institute are ensuring the patients have a say in prioritizing its trials, an approach being adopted by other organizations.

Ensuring the participants have some say in the trials that they find important has led to organizations realizing what is important to their patients. Overwhelmingly, patients have placed the most importance on the day-to-day management of their conditions. The proper handling of their clients' needs is estimated to save up to 80% of expenses spent on clinical trials, making the process of clinical trials massively more efficient.

A novel concept that has been shown to show promise is patient associations leading their own research projects. Involving the patients in the study's design has been shown to improve clinical trial participation and involvement. Personalizing the experience and involving the participants from an early stage in the trial would increase the effectiveness of the trial and should become a priority.

Eligibility Criteria for Clinical Trials

The proportion of eligible participants who participate in clinical trials is shockingly small. Only approximately 5% of cancer patients typically take part in clinical trials. This is due to a breakdown in communication and sourcing of patients. The patients treated by doctors who play a role in the trial are selected to participate, but the broader pool of potential participants won't be informed and won't have a chance to participate. This method of selecting participants also influences the spread of racial and socioeconomic factors, placing a bias on those groups with access to certain health care services.

Clear Communication Surrounding Clinical Trials

Another factor that affects patient participation is the amount of information made available to them. The organizers of the trial must ensure that enough relevant information is made clearly accessible to any patients who would like to participate in the trial to decide whether they would like to participate.

In many cases, the documentation given to potential participants is overly complex and confusing. Due to this, approximately 30% of participants do not understand the full implications of participating in the trial. This can result in them not understanding the study's primary conditions and the possible adverse side effects or the availability of an insurance policy.

To ensure the participants understand fully what the trial entails and maintain trust between them and the organization, the documentation is given to explain the procedure must be easy to understand and contain all the relevant information. This will ensure the patients fully understand what they are signing up for and that they are not misled.

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Moving Forwards

All these points that have been outlined in this article contribute to the overall participant's experience. This is the most important point for ensuring patients continue to engage with clinical trials. There is quite a lot of variation between studies conducted on patient experience, which is probably due to many factors such as age, education, and trial phase. More research is needed to ensure the patient experience is as good as possible, ensuring return participation.

The aims outlined in this article are all to ensure that the participants have the best possible experience and to break the harmful stereotypes of clinical trials. However, to ensure all of these points can be put into place, the public must be more informed on what scientific research actually entails. The individual participating in the research must be informed and aware of what is needed for the trial to progress smoothly.

The image of research presented to the public must be updated. The overall feeling of suspicion and loss of control that is felt about scientific research must be rectified to allow the public to have an unbiased vision of scientific research and its applications. This can only be achieved with public engagement and outreach projects.

This will also help cultivate the "expert patient", a participant who has all the knowledge needed to understand the aims of the trial and what is needed from them to succeed. This will only be achieved by investing time and money in the education of the public.

To ensure the success of clinical trials, the information needs to be more accessible to the participants, and it needs to be ensured that they have all the information they need. Then patient participation and satisfaction will rise and break the stigma surrounding clinical trials.

References:

• Sacristan, J. et al., (2016) Patient involvement in clinical research: why, when, and how. Patient prefer adherence. https://doi.org/10.2147/PPA.S104259
• Schilling, I. et al., (2019) Patient involvement in clinical trials: motivation and expectations differ between patients and researchers involved in a trail on urinary tract infections. Research Involvement and Engagement.  https://doi.org/10.1186/s40900-019-0145-3

Further Reading

• All Clinical Trial Content
• What is a Phase 0 Clinical Trial?
• What is a Phase 1 Clinical Trial?
• What is a Phase 2 Clinical Trial?
• What is a Phase 3 Clinical Trial?