Patient Experiences with Clinical Trial Medicines and Instructions

Jul 01, 2018
Volume 27, Issue 7

This article is the fourth in a series on the results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2017 Perceptions & Insights Study. Nearly 12,500 people worldwide responded—including the public, patients, and study volunteers—and provided valuable insights into opportunities to improve global education, outreach, and engagement.

 

Sponsors have been investing heavily in patient engagement initiatives to reduce study volunteer participation burden and improve participation experiences. Optimizing the administration of clinical trial medicines and their accompanying instructions are critical means to establishing positive volunteer experiences, better compliance, and higher retention rates. The 2017 Perceptions and Insights (P&I) Study offers insight into opportunities for sponsors to optimize clinical trial medicine kits.

The 2017 P&I Study included 2,194 global clinical trial participants. These patients shared their experiences with different types of investigational medicines and accompanying instructions, their ability to remember to take their investigational medicine, and the support they received from site staff when asking investigational medication-related questions. Bottled medications were used most frequently by patients (23%), followed by blister packaging (15%) and pre-filled syringes (11%). The method of administration varied across regions. European patients reported the lowest use of bottled investigational medications (9%), and those from South America and Africa reported significantly higher use of topical investigational medications (17% and 19%, respectively) compared to approximately 5% in other regions.

In aggregate, experiences with investigational medicines and medical devices were generally positive. The majority of patients felt remembering to take and administering medicines was “very easy” (74% and 76%, respectively). Instructions accompanying investigational medications were also described by most as “very easy” to understand (74%), and the majority of patients thought site staff answered medication-related questions “very well” (68%). However, areas of opportunity to improve experiences and increase compliance emerge when the methods of administration and different patient populations are examined more closely.

Challenges by method of administration

Overall, investigational medicines in bottles proved to be the least challenging for patients when compared to other methods of administration. In the latest study, patients reported bottled investigational medications to be the easiest to administer (84% “very easy”) and to remember to take (80% “very easy”), followed by investigational medication in blister packets (74% “very easy” to take, 73% “very easy” to remember).

Patients whose medicines were more involved (i.e., administered via syringe, inhaler, or topically) expressed more difficulties, and the need for increased education and instruction was additionally noted. These investigational medicines were less likely to be considered “very easy” to administer by patients (see Figure 1) perhaps because these methods are typically more complex and may cause some discomfort. These patients were also less likely to feel their medicine instructions were easy to understand (63% syringe, 62% inhaler, 59% topical “very easy” to understand) compared to patients receiving their medication in bottles (81% “very easy”).


Figure 1

Challenges by specific patient populations

Difficulties specific to certain patient-subgroups also illustrate the need for increased education and support for particular populations.

Experiences with investigational medicines generally improved with age. Those 18 to 44 years old were significantly more apt to have difficulties administering their investigational medicines (16% “somewhat/very difficult”) compared to patients 45 or older (4% “somewhat/very difficult”). Younger patients were also less likely to feel site staff answered their investigational medicine-related questions well and found instructions to be more challenging to understand compared to older patients (see Figure 2).

Perhaps due to increased work or family commitments, younger patients additionally struggled to remember to take their medication (19% “somewhat/very difficult”) compared to older patients (3% “somewhat/very difficult”). Notably, in this most recent study, a higher proportion of younger patients stated they would have liked text messaging to have been used during their clinical trial for reminders. This may offer an innovative way to improve compliance and better engage a younger generation of trial participants.

Level of education also impacted experiences. Among patients with a primary level of education, less than half found administration to be “very easy” (49%) compared to patients with a higher education level (75% “very easy”). A similar pattern emerged when looking at understanding of investigational medicine instructions; 19% of patients with limited education described instructions as “somewhat” or “very” difficult to understand compared to patients who had a higher education (6% “somewhat/very” difficult).

Patients identifying as Hispanic or Asian also reported increased challenges with investigational medicines. Only 43% of Hispanic patients indicated investigational medicine administration to be “very easy” compared to 79% of Non-Hispanic patients. Just over half (53%) of Asian patients felt taking their medication was “very easy” compared to 78% of White and 74% of African American/Black patients. Both Hispanic and Asian populations experienced a harder time understanding instructions and were also less satisfied with answers to investigational medication-related questions (see Figure 3) from site staff.

The “so what?”

While the method of investigational medicine administration may be challenging and time-consuming to modify, simply providing easy to understand and culturally appropriate investigational medication education and support—particularly to those targeted populations discussed—can readily improve patient experiences and improve compliance. Furthermore, text messaging and other new technologies can also be leveraged to better engage with patients and remind them to take their investigational medicines.

 

CISCRP Research Services: Jasmine Benger, Nova Getz, Annick Anderson

 

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