Study Volunteer Insights into Clinical Trial Medicine Kits

For study volunteers, clinical trial medicine kits represent one of the most tangible aspects of their participation experience. A study volunteer's earliest impressions of a clinical trial are influenced by the medicine kit packaging and its instructions. And the ease with which study volunteers learn how to follow instructions and take their clinical trial medicine throughout the study, as required by the protocol, plays an instrumental role in ensuring that volunteers have a safe and positive participation experience.

Despite the importance of clinical trial medicine kits, surprisingly, very few if any clinical supply professionals have ever solicited feedback among study volunteers. There are many reasons why this is the case. Historically, most clinical supply decisions have been regarded as tactical and secondary to other scientific and operating decisions. As a result, decisions associated with the design, production, and delivery of medicine kits have often had to be made under very tight timelines with little flexibility for accommodating outside input. In the past, many sponsors and contract research organizations (CROs) have been reluctant to interact with study volunteers for fear that they may cross the purported line prohibiting them from ever communicating with patients. And as we have seen in many areas of clinical research, historically, some professionals have chosen to downplay the patient's needs and perspective believing that they knew best.

To address this unique opportunity to solicit feedback from study volunteers, the International Society of Pharmaceutical Engineering (ISPE) —a trade association serving technical, manufacturing, and clinical supply professionals—in collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP) conducted a major research program among a large community of study volunteers. This column summarizes the high-level results of the research and provides not only baseline data for comparisons with future research efforts, but also offers insights into ways that medicine kit design and implementation can be better leveraged to improve study volunteer experience.

A detailed report of the findings of this study is available on the ISPE web site (www.ispe.org/).

Method and response

An online survey—approved by an ethical review board—was conducted between May and September 2013. Globally, study volunteers were targeted using a number of outreach approaches (e.g., solicitation via investigative sites; social media communities; large online communities engaged with CenterWatch and with Acurian, a patient recruitment provider). Those who had received clinical trial medicine kits at home in a Phase II or III clinical trial within the past three years were invited to respond.

In all, 1,425 study volunteers completed the online survey. Although global responses were solicited, nearly all completed surveys came from study volunteers based in the United States, rendering the results representative of a U.S. population only.

This respondent base had excellent gender, age, and therapeutic area representation. Respondents received their study medication in a variety of formats: 42% in bottles; 30% in blister packs; 15% in syringes; and 8% each in inhalants or topical creams. The majority of respondents (76%) received only one clinical trial medicine in their most recent trial; 24% received more than one.

Positive experiences

Overall, study volunteers gave extremely positive ratings of their clinical trial medicine kits: 77% said that their medicine kit was "Very Easy" to use and 13% "Somewhat Easy." Bottles, topical creams, and inhalants received a relatively small proportion (4%-5%) of study volunteers reporting difficulty using them. A much higher proportion of study volunteers had difficulty using blister packs (12%) and syringes (8%).

An equally high proportion (91%) of study volunteers reported that it was "Very" and "Somewhat" easy for them to store their medicine kits at home regardless of medicine format. Six-out-of-ten study volunteers said that the design and layout of their clinical trial medicine kit helped them take their study medication on schedule. Approximately one-third said the design and layout was not helpful in this regard. Blister packs received the highest rating for its design and layout in helping study volunteers adhere to a schedule.

Half of all respondents said that there was nothing they would improve in the packaging and labeling of the medicine kit that they received. One-out-of-six study volunteers said that the labeling instructions were unclear or that the font size was too small to read. The remainder commented on a variety of improvement areas including reducing the amount of bulky packaging that made it difficult to carry and store the medicine kits and using more color to coordinate the use of concomitant study medications.

Throughout the online survey, study volunteers noted that in addition to kit design elements, research center staff (e.g., principal investigator, coordinator, pharmacist) plays an essential role in helping volunteers understand kit instructions and remember when to take their clinical trial medicine.

Medicine kit usage

Although the survey results present consistently positive ratings of study volunteer experience with medicine kit designs, the results on how volunteers are using their medicine kits offers a more mixed picture.

Study volunteer compliance with the medicine kit instructions appears to be very high. The vast majority of respondents—82%­­—reported that they always take their clinical trial medicine as scheduled. Another 17% reported taking it as scheduled most of the time.

Respondents said that dosing instructions on the medicine kit label and medicine kits organized with daily or weekly unit dosing played an important role in assisting compliance. More than half of volunteers rated dosing instructions (58%) and organized dosing units (51%) as "Very Useful" adherence reminders.

Although reported compliance appears strong, a relatively high percentage of study volunteers don't keep their clinical trial medicine in its original packaging. One-out-of-seven participants, on average across all formats, removed their clinical trial medicines and placed them in a more accessible or practical container. Syringes are most likely to be removed, with nearly 20% reporting that they took the syringe out of its original packaging (i.e., a travel cooler) to make room in their refrigerator. Study volunteers who removed their clinical trial medicines from bottles or blister packs typically placed the medicines in a weekly pill holder to help them remember when to take the medicine in the future.

The return of used and unused medicine kits by study volunteers also appears to be problematic. One-out-of-ten respondents reported that they did not return used and unused clinical trial medicine. In explaining this behavior, volunteers indicated that the clinical trial medicine return instructions were not consistently or clearly communicated to them. Many participants noted that no rationale was communicated about why returns are required.

More concerning, 22% of study volunteers admitted that they may keep unused clinical trial medicine for future use. These volunteers indicated that they're especially apt to do this if they believe the study medicine is safe and offers them some benefit.

There is clearly an opportunity for investigative site personnel, working collaboratively with sponsors and CROs, to communicate and educate study volunteers on when and how to return clinical trial medicines and why it is important to do so.

The importance of options

Throughout the survey, study volunteers conveyed strong wishes that they be given "options" to customize their participation experience. In so doing, volunteers sense that they're valued and that each volunteer's unique situation and needs have been considered and addressed. Although some study volunteers, for example, prefer to receive labeling instructions in printed form, others indicated a preference to receive them electronically. Nearly 40% of respondents indicated that receiving medicine kit labeling instructions by email would be "Useful"; and 24% indicated that text messaging would be a "Useful" way to receive label information. Not surprisingly, openness to receiving label information using digital communication and smart phone apps was much higher among younger respondents.

Study volunteers expressed a variety of preferences for receiving adherence reminders by email, text, or telephone. And some study volunteers conveyed interest in the ability to select whether their clinical trial medicine bottles have child-resistant caps on them.

Nearly eight-out-of-ten respondents indicated that it would be "Very" and "Somewhat" helpful and convenient to have repeat prescriptions and refills of their clinical trial medicine delivered directly to their home.