Clinical trials are one of the most important components in healthcare and medical device development today. Different types of clinical trials have specific goals. They are the primary way for researchers to conclude whether a new medical device is safe and effective or whether a new treatment is more effective than the current standard. They can also be used to test new ways of detecting diseases early or to prevent a health problem, known as a screening trial. With over 100,000 clinical trials in the U.S. currently, there are many reasons why it’s important that medical device manufacturers and researchers continue to recruit diverse participants and retain them through the experience. The easiest way to do so is through building a relationship and maintaining consistent communication.
Below are three best practices for communicating with patients during clinical trials in order to build a trusting relationship and ensure a successful trial. These practices could serve the clinical research organizations (CROs) running these studies as well as medical device manufacturers working in partnership with CROs to test the effectiveness of a device.
Provide Clear Information About What Patients Can Expect as They Navigate the Journey of Participation
As soon as a patient signs on for an upcoming clinical trial, remember to be transparent about the amount of time and effort the trial will take. It is reported that approximately 30% of patients in clinical trials drop out over time, resulting in heavy financial costs and a lack of key data. To ensure maximum participation, developers and researchers need to provide clear, ongoing information on things such as:
- The number of visits. Clinical trials can require around 10 ongoing visits over a set course of time.
- What each visit will be like. Are patients required to take vitals (blood work, testing, etc.) during each visit? How should patients prepare or what should they expect? Researchers should provide answers to common questions before each visit without prompt.
By providing as much information as possible, patients can better understand and prepare for their clinical trial and as a result, are less likely to drop out of the study. Losing a patient is not only time and money spent, but it also means a loss of valuable data. Once a patient drops out of the trial, the data collected from them is no longer usable and the process will need to begin with an entirely new patient. Oftentimes, studies get delayed by at least a month due to participants dropping out, causing potential losses of approximately $600,000 per day.
Have a 1:1 Champion for the Patient to Navigate Their Journey and Build a Trusted Relationship
Going through a clinical trial may be a difficult or scary time for a patient, especially if it’s their first one. Make sure to offer a one-on-one partner to help guide them through the process and to help with questions and concerns, while also encouraging them through each step. Patients are more likely to be engaged in the trial if they have someone they feel close to and are likely to return. For example, Hawthorne Effect’s Hawthorne Heroes connect to patients on a human level, meeting them in their homes and going through the entire process with them there.
When conducting a clinical trial, manufacturers and researchers must develop meaningful relationships with their participants through ongoing communication before, during, and after a trial. Continued communication helps build immediate trust with the participant and can help with future recruitment efforts down the line.
Thank the Patient for Their Participation
Patients participate in clinical trials for various reasons. It could be a personal connection, someone they know or knew is struggling with a related health issue, or they felt the urge to be involved for the greater good. Whatever the reason is, always thank the patient for their participation. It may not be top of mind for them, but participants are contributing to the future of healthcare for millions of others, so acknowledge the patient for taking the initial step and signing up as well as for the result their actions will have in the long run.
Think of COVID-19 vaccine volunteers. The millions of Americans who signed up to participate in COVID-19 vaccine clinical trials have changed the course of medicine throughout this pandemic. Without these volunteers, who knows where the country would be in vaccination development and execution. Within the healthcare industry, researchers need to continue to encourage clinical trial participation, as we saw with COVID-19. A simple thank you can help show appreciation and in turn, bring patients back for trials later on.
As the number of clinical trials continues to rise, researchers will need to be extra diligent in recruitment efforts to ensure participation numbers are met. The above three strategies will help medical device manufacturers and researchers when communicating with patients before, during, and after the trial. By fostering clearer communication and creating stronger relationships with patients, we may see a drastic shift in patient participation for future studies.