Patients Come First. Deal with It!

by Stephanie Burns

“The good physician treats the disease; the great physician treats the patient who has the disease.” (Osler)

This concept is simple – good healthcare workers and a good healthcare system will have more patients (thus more funding) than a bad healthcare system. The goal of the system (or physician) is to treat patients, and the patient’s goal is to be treated.

Unfortunately, this concept is not as simple with clinical trials. In its purest form, research evaluates the safety and effectiveness of an investigational drug or device. Physicians participating in clinical trials must conduct the research without bias with respect to the outcomes. As such, the industry is inherently more focused on the science rather than the subjects. Protocols are designed to control any potential variables that could skew data or produce irrelevant or unreliable data.

My passion in this area is rooted in my past experiences in university and government-grant funded psychological research. As both a study coordinator and a protocol therapist I experienced firsthand the conflicting aims of maintaining scientific objectivity while still focusing on the patient’s basic needs.

During one particular supervision meeting, I was recounting the case of a patient in the control condition and expressed frustration that they were not improving at the pace the patient had expected. I was told to remove my emotional involvement and keep in mind that we were to serve science, not the patients. This particular patient’s lack of improvement was beneficial to the study as it strengthened the data. This conversation left a lasting impression on me.

One of the most fundamental goals of research is to generate a statistically significant sample size (larger sample, greater statistical power). Clean data is also dependent on significant patient retention. It doesn’t matter if you recruit millions of participants if only a few are willing to make it to the end point. It stands to reason that a study would be best served by incentivizing patient retention on a personal level.

The growing importance of recruitment and retention has finally given rise to a shift toward more patient-centered clinical trials. In response, more trial sponsors are tailoring protocols to meet the needs of the target population without losing the scientific integrity of the study itself. When developing a patient-friendly protocol, the first step is to examine the population of interest. What are their needs? What are their concerns? What are common motivators? While these answers may vary from study to study, there are a few universal needs of patients that should always be considered.

1. Access to information: Patients want to be informed. This goes beyond the required informed consent prior to study entry. Anticipate that patients will want to know what is going on at all times. Develop materials that will provide information about the study indication, drug, visit procedures, etc., in language that is easy to understand.

2. Participation roadmap: When it comes to the world of physical and mental health, no one likes surprises. Visit and procedure information should be readily available so the patient feels comfortable and prepared.

3. Convenience: This can be a tricky factor with many studies as some require frequent office visits or regular patient diary entries. The easier you can make the patient’s experience, the greater their chances of protocol compliance.

4. Benefits: While there are regulations on the amount of compensation that can be provided to participants, any creative benefit will always give you a greater chance of retention.

In summary, put yourself in patients’ shoes and put their needs first. Analyze potential obstacles to participation, and develop creative means to overcome those obstacles in partnership with your population of interest. Seek out external resources to make your study more patient-friendly. If you want the data, you need a strong sample size. To get that strong sample size, you want to create a protocol that makes patients feel like they are treated with respect and care.

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