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Patient engagement in clinical trials | Patient engagement in clinical research
8 steps to patient engagement

Engaging patients is one of the biggest challenges in conducting clinical trials. Clinical trials need reliable and consistent patient participation. The more engaged and motivated your participants are, the better results you’ll get from your trial — but how can you maximize patient engagement?

There are many different strategies to help improve patient engagement, from the very start of a trial to its conclusion. From identifying key stakeholders to utilizing digital platforms, these eight steps will help ensure your patient engagement levels remain high throughout your study.

Identify Areas of Improvement in Patient Engagement

The first step to increasing patient engagement in clinical trials is to identify areas of improvement. This involves understanding patients’ most common issues during the clinical trial process and identifying ways to improve the patient experience. These issues may include a lack of awareness about available clinical trials, an overly lengthy enrollment process, or difficulty accessing needed information quickly. Knowing your patients’ challenges can help you create solutions that will make participation in a clinical trial easier and more engaging for them.

Additionally, it’s important to take the time to understand why certain patients are more likely to be engaged than others. Contemporary research suggests that there are certain demographic, socioeconomic, educational, and lifestyle characteristics that all contribute to a patient’s willingness to participate in a clinical trial. By understanding these correlations, you can target potential participants and create more effective strategies for outreach, recruitment, and retention.

Utilize eTMF to Improve Patient Engagement

Clinical trials are essential for research and progress, but keeping patients engaged and informed throughout the process is key to success. eTMF (electronic trial master file) is a tool that allows for efficient storage and tracking of all trial documents to streamline the clinical trial process.

Using eTMF helps to ensure that patient engagement remains high by providing quick access to all relevant documents, from protocol summaries to patient information sheets. It also allows sponsors and sites to easily review and manage documents, which reduces the burden on staff who would otherwise be responsible for manually tracking these documents.

One centralized repository ensures that all information is up-to-date, as any changes can be immediately reflected in the eTMF system. This helps to minimize any confusion or inaccuracies during a clinical trial, allowing patients to trust that they are receiving accurate information throughout the process.

Leverage Electronic Data Capture (EDC) Systems to Collect Data

Electronic Data Capture (EDC) systems are an effective tool for collecting data in clinical trials. Here are some ways that EDC systems can be leveraged to collect data:

Overall, EDC systems are an effective tool for collecting data in clinical trials. By improving accuracy, efficiency, accessibility, security, customization, and data monitoring, EDC systems can help ensure that the data collected is of high quality and can be used to inform clinical decision-making.

Create a Participant Portal to Engage Patients

Creating a participant portal is an effective way to engage patients in clinical trials. A participant portal is a website or mobile application that allows patients to access information about the trial, communicate with study coordinators, and participate in the trial remotely. Here are some ways a participant portal can be used to engage patients:

Access to trial information

A participant portal can provide patients easy access to important trial information, including study protocols, informed consent forms, and patient education materials. This can help patients understand the trial process and their role in it.


A participant portal can facilitate communication between patients and study coordinators. Patients can use the portal to ask questions, report adverse events, and provide feedback on their experience in the trial. This can help build trust between patients and study sponsors and improve patient engagement.

Reminders and notifications

A participant portal can send reminders and notifications to patients, reminding them of upcoming appointments, medication schedules, and other important events. This can help improve patient adherence and reduce the risk of missed appointments or medication doses.

Remote monitoring

A participant portal can remotely monitor patient data, including vital signs, medication adherence, and symptom reports. This can help study coordinators detect issues early and intervene when necessary.


A participant portal can be gamified using rewards, badges, and other incentives to encourage patient engagement and adherence. This can help make the trial more engaging and motivating for patients.

Overall, creating a participant portal is an effective way to engage patients in clinical trials. By providing easy access to trial information, facilitating communication, sending reminders and notifications, remote monitoring, and gamification, a participant portal can help improve patient engagement and adherence, leading to more accurate and reliable trial results.

Using Engaging Digital Media to Reach Target Demographic

Engaging digital media is an effective way to reach the target demographic and engage patients in clinical trials. Digital media includes social media, online ads, blogs, videos, and other types of online content. Here are some ways digital media can be used to reach the target demographic:

Overall, using engaging digital media is an effective way to reach the target demographic and engage patients in clinical trials. Using social media, online ads, blogs, videos, and mobile apps, study sponsors can reach patients most likely interested in the trial and provide them with the information and resources they need to participate.

Develop Proactive Strategies for Follow Up With Patients

Engaging patients in clinical trials is about more than just recruiting them. It’s also about keeping them engaged throughout the trial. Developing proactive strategies for follow-up with patients can help ensure that they stay with the trial until completion.

Here are some strategies that can help you improve patient engagement and adherence to the protocol:

  1. Establishing a dedicated follow-up team to check in with patients at regular intervals
  1. Utilizing innovative survey tools, like online forms and phone apps, to keep in touch
  1. Having protocols in place to reach out to patients who miss appointments or fail to complete surveys
  1. Encouraging participants to bring up any issues or concerns they have
  1. Scheduling “check-in” calls and questionnaires for tough periods of the trial, such as the middle or end phases
  1. Giving incentives for those who complete their portion of the trial on time
  1. Being aware of any potential barriers that could interfere with successful participation, such as language barriers or lack of transportation
  1. Keeping in contact with participants after the trial is completed

These tactics are especially beneficial when studying a chronic condition because it can be difficult for patients to maintain consistency over a long period — but following up proactively will make them more likely to stick with it until the end!

Enhancing Study Communications With Patients

You can never have too much communication regarding patient engagement in clinical trials. Enhancing study communications with patients will help keep them informed of developments and new study details as they arise, which, in turn, can help prevent any potential delays in the study.

Here are some ways you can improve communications with patients:

By utilizing these strategies, you can ensure that your patient engagement strategy is effective and successful—allowing you to maximize patient engagement within your clinical trials!

Analyzing and Adjusting Strategies to Improve Engagement Outcomes

Analyzing and adjusting strategies is a crucial step in improving patient engagement outcomes in clinical trials. Here are some steps that can be taken to analyze and adjust engagement strategies:

Define engagement metrics

Define engagement metrics that can be used to measure the effectiveness of engagement strategies. These metrics may include patient recruitment rates, patient retention rates, patient adherence rates, patient satisfaction rates, and other relevant metrics.

Collect and analyze data

Collect data on engagement metrics throughout the trial, and analyze the data to identify trends and areas for improvement. Use tools like surveys, questionnaires, and patient feedback to gather data and feedback on patient experiences.

Identify areas for improvement

Based on the data analysis, identify areas for improvement in engagement strategies. This could include changes to the participant portal, modifications to the study design or protocol, or adjustments to digital media strategies.

Adjust engagement strategies

Implement changes to engagement strategies based on the areas for improvement identified through data analysis. For example, if patient adherence rates are low, adjustments could be made to the reminders and notifications sent through the participant portal.

Monitor and evaluate outcomes

Monitor the impact of adjusted engagement strategies on engagement metrics, and evaluate the outcomes to determine if the changes have had a positive impact. If engagement outcomes have improved, continue to use the adjusted strategies. If not, further adjustments may be needed.


Patient engagement is an essential factor for successful clinical research. Investing in technologies such as eTMF and EDC that help to engage patients will not only increase trial enrollment but will also result in better overall trial outcomes. The key is to ensure that clinical trials are designed with the patient in mind from the very start. It is crucial to use tactics that make it easier for patients to be part of the clinical research process and to provide the best care and treatment possible. By maximizing patient engagement, clinical researchers can optimize their results and move clinical research to the next level.