This is part 2 of a 2 part series on patient centricity in clinical trials. You can read part 1 here.
In this follow-up to our recent discussion on clinical trial enrollment, we will discuss how an emphasis on patient centricity will help clinical trial researchers overcome a few challenges when trying to enroll in research subjects.
1. Complexity of the study
Although pharmaceutical companies and clinical research organizations (CROs) are fluent in the operational complexity of clinical trials, they must remember that potential research subjects are not. In fact, many patients may have only a basic understanding of what a clinical trial is and what they can expect to experience. Researchers must always think of the participants as people with needs, expectations, and fears; they are not simply potential data points in a study.
Researchers must communicate with potential study participants about not only what clinical trials are in general, but also what this specific clinical study will entail. This might include the types of procedures and tests they will have if they participate, how many appointments they will have, when, etc. By talking to participants and understanding their perspective, researchers can facilitate better clinical trials through patient centricity. The informed consent form is a helpful tool to facilitate this conversation, but it does not supplant the valuable face-to-face interaction that a potential subject has with a researcher. It is better to think of the informed consent form as an indication that a conversation took place, but not as a conversation in itself.
2. Fear of the unknown
If study participants do not feel that their questions are addressed by the researchers, or if they do not trust the information that they are given, they will seek other ways of getting the information. Some participants may turn to social media to connect with other participants through a private Facebook group or Twitter chat. These conversations between patients may result in inadvertent or intentional unblinding when patients compare symptoms or find out about how the other patient is reacting to the drug or placebo. Of course, this can have damaging implications for data integrity if the conversation ‘un-blinds’ the subject.
This situation can be mitigated by proactively connecting participants to one another. This would allow patients to have their questions about study experience answered, but can be done in a way to prevent improper disclosure of secure information.
3. Discussing patient experience
There are key aspects of patient experience that need to be discussed in order for study participants to feel comfortable participating in a research study.
Patients like to hear about the experience from the perspective of other patients. When a clinician describes a certain test or procedure, they describe the events that take place and what the possible risks might be. When a patient describes it, they describe how the event felt from their perspective; they will say if it was painful, or uncomfortable, or nothing to worry about.
However, there is a large part of the conversation that is not exactly clinical in that it is not focused on reactions to the drug. Still, when making any type of commitment or decision, people generally want to know what that entails so they can decide if it will work with their lifestyle. Some examples of common questions about patient experience might be:
- How many appointments will I have and when will they be?
- What happens if I need to cancel an appointment?
- How many times will I need to get my blood drawn?
Potential side effects and the likelihood of experiencing should be communicated in a way that people without a lot of medical education can easily understand. With that in mind, some people will need more explanation than others to understand what might happen in the study. Some patients will readily understand the impacts of liver damage, for example, and others may need to be told what is the function of the liver in the body.
Just as the level of conversation will need to be tailored to the person, the preferred method of communication may differ too. Depending on the technical literacy of the person and sensitivity (or not) of the research, communication may take place via phone calls, emails, newsletters, or online platforms such as a Podium.
Final thoughts
People who participate in clinical trials, the ‘subjects’, do so at sometimes a significant personal cost with no reason to expect to be cured. Their opinions and feelings about the study can affect adherence to the protocol, communication, and reporting of adverse events, and retention in the study. They are subjects, but they are also partners in research. By adopting an attitude of patient centricity, Sponsors can be better partners and achieve better enrollment and retention.
This is part 2 of a 2 part series on patient centricity in clinical trials. You can read part 1 here.
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I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the first podcast episode that inspired this post here or on Soundcloud.
