With more than 200,000 clinical trials expected to be underway by the end of this year, researchers are faced with more challenges than ever before when it comes to managing studies and retaining patients. Patient engagement is a key driver of success in any clinical trial, but due to issues related to patient trust in the study designers, the design of the study itself, and the requirements for participation, that engagement isn’t always as high as it could be.
One reason that clinical trial engagement tends to decline is that the reality of participating in a study doesn’t always meet the patients’ expectations. Often, when patients feel like the study requires more work than expected, in terms of recording data, physician visits, etc., their enthusiasm wanes and they eventually fail to complete all of the requirements or drop out of the study. In other cases, patient expectations in terms of outcomes aren’t met; for example, if they are part of a trial for a new treatment for a chronic condition and do not immediately see results, they may become frustrated and quit the trial.
Regardless of the reasons that patients leave clinical trials, the effect is the same, and can influence outcomes. Successful researchers have discovered, though, that expectation management is a key to getting and keeping patients involved in the clinical trial process.
What Patients Expect From Participation
There is a saying that people who never expect anything are never disappointed. While never having any expectations would be ideal, that’s simply not realistic. People will always have at least some expectations about what your clinical trial is going to entail, based on the information you give them, what they already know about clinical research, and their assumptions about the process based on what they’ve seen or heard in the media, from talking with others, and other sources.
So what do patients expect? In general, they want to know:
- What the risks are of the study and the treatments they will be receiving
- What the potential benefits of the treatment will be
- How the trial will affect their everyday lives?
- What the time commitment is for the study, in terms of seeing providers, recording information, etc.
- How they will record information
- The costs associated with participating in the trial
- Is participating in the study safe?
- The rules of the study, such as communicating with others about the trial, etc.
These are just some of the most common questions that patients have, but overall, the typical study participant expects that the treatment they will be testing is going to make them better, not worse, and that participation is not going to impact their lives too much. They don’t want to spend hours waiting in doctors’ offices or recording data, and if that’s required, they want to know ahead of time.
Communication and Technology
Clearly, the key to keeping patients engaged in clinical trials is to communicate clearly from the very beginning of the recruitment process. Leave no room for assumptions; assumptions often lead to disappointment and frustration when others do not share the same understanding of the study and processes that you do. Developing comprehensive materials, offering plenty of time for questions, and providing plenty of ongoing communication can prevent assumptions and ensure that the patients remain engaged to the end.
Technology can play an important role in this expectation management as well. Multiple studies indicate that patients prefer to use mobile technology — smartphones, tablets, laptops, etc. — to record their electronic clinical trial outcomes over paper or interactive voice response systems. Using an eCOA solution designed for the study’s specific therapeutic areas can make it easier for patients to record their data, reduce the likelihood of errors, and improve overall engagement with the study.
Other methods that have been proven helpful in managing patient expectations include:
- Comprehensive patient information portals that offer detailed information on the study protocols, the treatment, and other additional information that can be accessed on-demand.
- Offering “trial runs” of the study, allowing participants to use the electronic system before the trial begins to ensure familiarity and comfort and work out any bugs.
- Acknowledge participants’ time and commitment, and be available to address concerns or questions.
Managing a successful clinical trial requires more than simply recording data and drawing conclusions. It also involves keeping patients engaged even when they don’t necessarily want to stay involved. By managing expectations and answering all of their questions ahead of time, you can improve engagement and the validity of your research.