Nov 8, 2019

Prior to conducting a clinical study of a product (device, drug, and/or biologic), it is recommended that manufacturers perform a human factors validation (i.e., summative usability) study of the product before it will be used on humans.

Such studies ensure that the investigational product is safe and effective for use by intended users, uses, and use environments. In addition, it is valuable to consider how human factors engineering (HFE) work pertaining to ancillary products used in the clinical study can help ensure the overall success of a product in development. In other words, the application of HFE work to ancillary products can help towards the goal of the clinical study – to establish the safety and effectiveness of the investigational product for the proposed indication.

Adherence products for clinical studies

Here, we focus on ancillary products related to patient adherence in clinical studies (e.g., smart pill bottles, smart packaging, smartphone applications). Adherence can include taking medication, as well as following the treatment regimen, adhering to the study protocol, adhering to study visits, and reporting adverse events.

Importance of adherence: Poor adherence can undermine clinical studies and compromise the reliability of study results, including those related to the product’s risks, benefits, and dosing. Poor adherence can also potentially cause delays or additional costs, as well as increase risks to the participants’ safety.

Factors affecting adherence: Adherence can be affected by many factors, including use-related factors: treatment regimen complexity (e.g., dosage, frequency), patient understanding of the treatment regimen, patient perception of risks and benefits, patient condition (e.g., mental illness) or impairments (e.g., cognitive), and communication between the patient and research team.

HFE for adherence products in clinical studies

While HFE work conducted on ancillary products for use in a clinical study has many similarities to HFE work conducted for device marketing applications, there might also be some additional, unique considerations. For example, will you be developing your own adherence technology, or selecting an already-marketed adherence technology? Are there any differences between user groups in the clinical study versus actual use (e.g., different healthcare professional or patient qualifications)? Are there use steps unique to the clinical study (e.g., different disposal method)?

Factors to consider: Many factors should be considered when determining whether the adherence technology meets the needs of its intended users, including:

  • User characteristics (e.g., patient abilities and impairments)
  • Ease of use (physically and cognitively)
  • Potential safety-related use errors
  • Effectiveness in encouraging adherence
  • Adherence monitoring accuracy
  • User acceptance (e.g., fit with patient lifestyle or clinician workflow, comfort with monitoring’s invasiveness)
  • Adherence data accessibility (clinicians only, clinicians and patients)
  • Compatibility with investigational product

Interactions to evaluate: A human factors (i.e., usability) study of an adherence technology might include some of the following evaluation activities:

  • Patient performance of hands-on tasks (e.g., medication intake, data transfer, data entry)
  • Clinician performance of hands-on tasks (e.g., technology setup, patient training, intervention in cases of non-adherence)
  • Patient interpretation of instructions, reminders and notifications, adherence data
  • Clinician interpretation of adherence data

Using an inappropriate adherence technology can potentially frustrate users, including patients and clinicians, and ultimately be counterproductive. As such, the application of HFE prior to clinical studies, for both the investigational product as well as ancillary products, can help toward the overall success of the product development process.

Tricia Gibo is Senior Human Factors Specialist at Emergo by UL’s Human Factors Research & Design division.

Learn more about HFE and usability issues for medical devices at Emergo by UL:

  • HFE user research support for medical devices and IVDs
  • Medical device and product evaluation
  • Webinar: Methods for identifying potential use errors