The trials of tomorrow will be conducted today
Clinical trials are a crucial part of the journey to approval for new medicines and treatments. If you’re unfamiliar, they represent the third phase of drug development, after preclinical (animal testing) and phase one (human testing). Phase three clinical trials are what allow us to test medications in larger groups over longer periods of time, helping us gather more information about potential side effects or issues that arise before we can begin prescribing them. Without this final step in the process, it would be impossible for new drugs to come onto the market.
As you might imagine, there’s a lot at stake when it comes to clinical trials: if something goes wrong during testing, it not only could put patients’ lives at risk but also has major ramifications for the company conducting the trial. That’s why patient enrollment is so important—it ensures that participants receive proper care while allowing researchers to collect sufficient data from their trial. Although it’s a necessary step in developing new medications that will benefit countless people around the world later on down the line, patient enrollment is often one of the most challenging phases within clinical trials because of its potentially high cost and lengthy duration.
Scientific leadership is essential
It’s important to have scientific leadership that takes the lead in developing study protocols and maintaining regulatory compliance. These are the people who will be responsible for designing studies, recruiting qualified participants, and then, of course, avoiding all types of fraud or misconduct.
Therefore, it’s crucial to find people who have a passion for developing new treatments as well as a knack for keeping research projects on track. With the right leadership in place, you can go from having zero patients enrolled in your clinical trial to having too many patients—and then some!
Relationships and communication are key
It’s also important to focus on building relationships with patients. By taking the time to form a rapport with each potential participant, you can ensure they’re not just signing up out of obligation or a fear of confrontation, but rather because they actually want to help move science forward. Building trusting relationships can also help you gain feedback and insight into how your recruitment efforts are going, allowing you to make changes in response to what you hear from patients and better serve their needs.
Excellent communication is another key aspect of increasing patient enrollment in clinical trials. You must clearly relay all details about the trial in an easy-to-understand way so that patients know exactly what’s expected of them if they agree to participate. Through effective communication, you can also learn more about their personal situation and gauge their willingness to take part in a clinical trial based on that information.
This article is excerpted from “Improve Your Clinical Trial Enrollment Process by Taking The Patient’s Experience Into Account.” To read the full article and learn more about how vital it is to prioritize patient experience throughout your entire clinical trial recruitment process, click here:
There’s no “one size fits all” solution to patient engagement
There’s no one-size-fits-all solution to patient engagement. Nor should there be. There are different levels of patient engagement, and the right approach for a particular organization and trial will depend on what level you want to achieve.
For example, if you want patients to enroll in your clinical trial, it makes sense to engage them differently than if you want them to participate actively in the development of a treatment or device. It also makes sense that a clinical researcher who wants people with type 2 diabetes mellitus (T2DM) to self-monitor their carbohydrate intake would not use the same approach as one who wants patients with Parkinson’s disease (PD) to track their tremors at home each night for four weeks before the start of the study. The former group might find an app helpful; those with PD may prefer an old-fashioned notebook and pencil.
To know whether your patient engagement approach is working, it’s important to get regular feedback from patients so that you can assess what works—and doesn’t work—for them.
The customer experience is a top priority
This trend is especially notable across the healthcare industry, where an increasing number of organizations are prioritizing patient experience to improve quality of care. It’s a smart move: not only does excellent customer service improve brand perception and encourage higher rates of return; it also helps cultivate trust among patients.
With clinical trials, this emphasis on the customer experience is essential for two key reasons. While it’s true that sponsors and CROs want to help their customers feel comfortable during the study process, these organizations must also meet strict regulatory requirements in order to safely collect data from participants. As such, sponsors and CROs need an efficient way to track patients’ progress through every step of the trial and ensure that each participant receives adequate treatment and assistance as needed.
Data, data, data!
Data is essential from start to finish in the clinical trial process. Data drives the decision-making process and helps develop insights for the next clinical trial. It also gives researchers an understanding of the patient and their needs, which is critical to patient enrollment.
Innovative software and technology are needed to manage data effectively throughout a drug’s life cycle. Accurate data entry and reporting are critical to patient enrollment—and also serve as a foundation for conducting post-marketing studies and continuing trials. Software improves efficiency, accuracy, and compliance with industry standards for data management
Patient enrollment in clinical trials needs to happen fast, but effectively.
If you’re a patient receiving treatment for a serious disease, you may be happy to learn that your research participation can have profound personal and emotional benefits. But these benefits come only after you’ve been recruited into a clinical trial. And if patients are the most important part of the clinical trials process—as they are—you’ll need to take action quickly if you want to participate in one.
The first step is having someone who can speak on your behalf contacted by the company that’s developing your medication. This person is your representative, and will help ensure that all of your questions will be answered and that all of your concerns are addressed. From there, you’ll need to complete an electronic survey so the entire process can begin more efficiently.
Diversity in patient enrollment for clinical trials
- In order to address these safety and efficacy issues, clinical trial diversity is a top priority.
- Demographic data tells us that women and people of color are still underrepresented in clinical trials. In order to increase the diversity of patient enrollment, we recommend reaching out to diverse trial sites.
- When recruiting patients, get creative with your use of language when speaking about your study so that the focus doesn’t seem centered on one group or another; be inclusive when referring to potential participants in terms of race and gender.