Human factors in clinical studies: bridging the gap

In some instances, however, ‘actual use’ studies are required in the clinic to assess the usability and safety of a device. At Team Consulting, we have worked on a number of actual use or ‘clinical-in-use’ Human Factors studies, working directly with physicians and/or patients to assess a drug delivery device interface by observing real administrations.

In all cases, this was because the regulatory agencies felt that there was an element of assessment which could not be simulated, but which required actual use*. These HF evaluations – whether pre-submission or a post-market requirement – have therefore been run as part of a clinical study to ensure patient safety.

*An example of a regulatory agency requesting an actual use study can be seen in the FDA response to Regeneron’s Eylea application. “There is no clinical or human factors data provided that utilises the proposed commercial prefilled syringe. A clinical study in at least 30 subjects utilising the proposed commercial Eylea (aflibercept) Injection prefilled syringe configuration should be submitted.” Note that Team was not involved in running this study.

Clinical study teams rarely have experience of the requirements of human factors studies, and vice versa. Having run numerous HF-in-clinic studies in recent years, we have the following recommendations to help HF-in-clinic studies run smoothly – and they’re all about communication:

Discuss requirements and roles early on with the clinical team

Kick off with an open discussion with key members of the clinical, device and Human Factors teams, where the HF experts can explain exactly what an HF assessment entails and discuss the requirements of working on site. Clinical teams and clinical study sites will not be accustomed to having to plan for visitors to be present during the study, nor for the careful scheduling required across the study sites to allow the HF team to attend and observe all patient visits.

Even apparently simple requirements can be a challenge here and should be planned for in advance. For example, if the study is intended to assess patient instructions for a drug delivery device, the site will need to provide a room and table large enough for patients – and perhaps their caregiver – to spread out the instructions and other materials in the package while being observed and recorded. Hospital research teams do not always have this type of room readily available.

Ensure regular communications between the Human Factors and clinical teams

Plan in more opportunities for regular communication between the Human Factors team and the clinical team than you think can possibly be needed, and then add some more. It takes time to navigate the differences in expectations, procedures and vocabulary, but the investment is worthwhile – getting it right will save time, money and frustration. Clinical team members tend to change between first discussions and study implementation as well. You’ll likely find that the key messages will need to be revisited throughout the planning.

Consider potential patient privacy issues early on in the Human Factors study

Address the potentially tricky areas early. For example, Human Factors teams always record administrations and interviews on video, so they can go back and check details if required. Every clinical team I’ve worked with is concerned about this – and understandably so, as the privacy of patients is at stake. Ensure you have robust data handling procedures in place, explain why the video is needed, and encourage clinical teams to include video recording in the study protocol. In the various clinical studies we have run, which have involved dozens of study sites, we have only encountered one (local) Institutional Review Board (IRB) that would not approve use of video with appropriate consent.

Establish relationships between teams

Find time for the Human Factors team to ‘meet’ the study site staff and study monitors and establish a relationship. If not in person, this might be at an online investigator meeting or via planning calls. This will help enormously when the team is on site. Some of these studies – especially those in busy outpatient clinics – take place in a whirl, with packed schedules and busy physicians who may find it difficult to stop and answer questions after an administration. Starting each day with good will and good humour is essential as the only thing that’s certain is that it won’t all go to plan!

Have the right Human Factors team in place

Finally, fielding the right people on the Human Factors team is key – they will have to have the protocol, the device and the procedure ‘in their bones’ so they can keep up with, say, the speed of administration and patient turnaround in a retinal clinic. They may also need to be diplomats with the site staff who are under pressure, or the patients who may be stressed by the procedure or the waiting time.

Running Human Factors studies in clinic can seem daunting, but with good planning and communication, with the right teams and mindsets, they needn’t be.

We’ve loved having the opportunity to work on these projects – we’ve very much enjoyed being a part of several clinical teams, and it’s a privilege to work with physicians, nurses, site staff and patients to help bring valuable new drugs to market.

Reference:

^[1] Antoszyk AN, Baker C, Calzada J, Cummings H, So J, Quezada-Ruiz C, Haskova Z. Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):411-419. doi: 10.5731/pdajpst.2017.008342. Epub 2018 May 31. PMID: 29853609.