Patients taking part in clinical trials are keen to comply with study protocols and want the trials to succeed, a new study has found.

Evidence suggests that patients invest in protocol compliance when they understand what the protocol is and the underlying rationale for its requirements.

It is therefore important that Investigational Medicinal Product (IMP) professionals explore ways to improve patient understanding of the clinical-trial process and facilitate compliance within the confines of a scientifically sound study design, concluded the International Society for Pharmaceutical Engineering (ISPE).

Patient-experience survey

These were among the key initial findings from a global survey of patient experience with clinical-trial materials, which the IPSE said was industry’s first large-scale effort to collect data of this kind from patients engaged in clinical trials.  

Underwritten by 11 companies involved in clinical research, the ISPE survey assessed patient experiences in areas such as the suitability of clinical-trial packaging; label information and designs; interactions with clinical-trial technologies; and the transportation and storage of IMPs.

A report based on responses from 1,425 patients, the vast majority of them in the US, was released at the 2013 ISPE Annual Meeting in Washington, DC.

Satisfied with kit

The study found a high level of patient satisfaction with medicine packaging and instructions offered in clinical trials, with around 90% of respondents finding these elements either “very easy” (77%) or “somewhat easy” (13%) to use.

Self-reported protocol compliance/treatment adherence was also high. A full 82% of respondents said they always took their clinical-trial medicine when they should and 17% when they should “most of the time”.

Moreover, 60% of the respondents felt the design/layout of the medicine kit positively affected their adherence to the dosing schedule.

Improving compliance

In its initial analysis of the data, ISPE concluded that further improving protocol compliance in clinical trials would probably need to involve two types of adjustments.

Firstly, there was a need to examine how patients are informed about critical aspects of a clinical trial.

Patients must “know about and understand the role of the patient within a trial and how that role relates to decision-making for doctors and patients”, the report commented. “They also need to be informed about the role of (and necessity for) clinical controls.”

The survey data strongly suggested that informed patients who feel they are a part of something are more likely to be compliant and to complete a clinical trial, ISPE noted.

Secondly, changes to clinical materials and how information is communicated may also increase patient compliance, the report suggested, adding: “Changes that will make it easier for patients to take their medicine as directed will probably increase the number who ultimately complete the study”.


Another key finding was that customisation and accommodation of patient differences are essential in clinical trials. Respondents to the survey indicated a variety of ways in which a ‘one size fits all’ was sub-optimal from their perspective in this context.  

“Certainly there are areas in which sound scientific inquiry requires rigorous consistency,” the report commented.

“Yet there are probably other ways that would be meaningful to patients that could be customised without jeopardizing the integrity of the study, e.g., how patients receive labelling information or reminders, how they communicate with site staff, and so on.”

The ISPE Patient Survey Project Team will continue to review and analyse the survey data over the coming months. The full report released at the Annual Meeting can be downloaded at