How to keep human factors (HF) programs moving forward during the pandemic – Part 1 In-person Studies
How to keep human factors (HF) programs moving forward during the pandemic – Part 1
During the current pandemic of the coronavirus, medical device and pharmaceutical companies are faced with keeping their human factors (HF) activities moving forward to achieve the originally planned outcomes for product development and regulatory submissions. Teams may be evaluating how to use their typical HF methods and how to conduct in-person studies under the constraints of the pandemic. With the uncertainty of the pandemic climate and the volatility of regional restrictions, having an adaptable approach for handling pandemic-related obstacles while executing HF activities is crucial. This newsletter is Part 1 of a 2-part series, where we will discuss adapting HF strategies and considerations for conducting in-person studies (Part 1) and remote studies (Part 2).
Adapting your current HF strategy
In life, there are many events we cannot predict, yet we prepare ourselves and plan for various scenarios to ensure we have the best outcomes if or when the unexpected happens. This strategy of planning for various scenarios can be applied to your HF programs during the pandemic to allow flexibility when the situation changes and to help you continue moving forward with your HF program. If you think through multiple contingency plans for different possible scenarios, such as increased infection rates at testing sites or new stay-at-home or shutdown orders, you can readily adapt your HF activities to the new circumstances.
Due to the impacts of the pandemic, many organizations find themselves “paused” in the middle of a product’s HF program or in late stages of HF testing with a regulatory submission date looming. The challenge is determining how to proceed and become adaptable when the original HF activities may no longer be possible or face significant delays to execute as planned. For example, when a product’s intended users include a population that is particularly vulnerable to COVID-19, is it feasible and safe to conduct traditional in-person HF studies with these users? How do you ensure that you are protecting the safety and wellbeing of your participants and research personnel while still moving forward with your HF program? Are internal company policies restricting whether you can proceed with in-person testing?
The best HF strategies to implement during a public health crisis like the current pandemic will hinge on your current HF investigational goals, type of device and complexity of the user interface, and how far along the product is in the product development lifecycle. Early in an HF program, there are many opportunities to conduct meaningful HF activities internally or using remote testing. However, as the HF program advances from preliminary analyses (e.g., use-related risk assessment, task use-error analysis, early formative evaluations, etc.) toward the validation end of the spectrum, there may be less and less flexibility for the types of HF activities that can be conducted remotely.
Creating contingency plans can also help mitigate delays in HF activities due to unexpected spikes in COVID-19 cases, changing coronavirus policies within your company, or unanticipated state, local or federal restrictions. For example, let’s assume you are planning an in-person formative evaluation to occur in a specific geographic area, but the COVID-19 cases suddenly spike a week before the study so that it would no longer be safe to conduct the study in person. If you had already considered this possibility during your study planning and developed a contingency plan to turn the in-person testing into a remote study, you can readily change tracks without significant delays. This will help you achieve some of the original HF testing goals and collect a portion of the HF data that you need. While you may not be getting the same robust data, a remote study may still enable you to collect some meaningful data that can help your HF program progress.
It is important to note that FDA has specified that any HF remote testing validation protocol must be reviewed by the Agency, and the Agency will determine the acceptability on a case-by-case basis.
When you consider adapting your HF program during the pandemic, there are three types of strategies that may be viable options:
Internal sponsor activities
Remote testing with users
In-person testing with users
The table below provides some example HF activities that may be appropriate, along with some considerations.
What are regulators saying?
While guidance for conducting clinical studies during the pandemic has been issued from regulatory authorities, less guidance has been provided about conducting HF studies, especially in-person studies crucial for submissions.
At the 2020 Virtual International Symposium on Human Factors and Ergonomics in Health Care, representatives from FDA’s CDRH and CDER, stated that any sponsor who was considering a remote testing HF validation study should submit their protocol to FDA for review prior to conducting the study. FDA will review these protocols and issue guidance on a case-by-case basis. Therefore, if sponsors choose to proceed with remote validation studies without FDA’s protocol review, they are doing so at their own risk.
With regard to HF testing in Europe, the European Commission has delayed the implementation of the EU Medical Devices Regulation (MDR) by one year to allow companies to focus on priority products and devices during the pandemic and, by extension, the related interruptions to other product development and compliance activities.
So, you’re considering an in-person HF study, what next?
Let’s say that you determined that an in-person HF study is required for your product. During the pandemic, participant and research personnel safety should be prioritized. If an in-person study cannot be conducted safely, then other options should be explored instead (e.g., remote testing). Part 1 of this newsletter outlines important considerations for in-person studies, and Part 2 of this newsletter (September) will discuss considerations for remote testing.
Considerations For In-Person Studies
If all other options for your HF program have been exhausted, or a remote study is not a viable option, you may be faced with how to conduct in-person studies – or making the decision if in-person studies can be conducted at all. When considering an in-person study, participant and research personnel safety is considered the top priority. You should consider the following when making decisions, which are also described in more detail below:
Participant recruitment challenges
COVID-19 safety management plan for study conduct
On-site logistics
Participant Recruitment Challenges
Can the study proceed without any added risk to the participant? Recruitment of study participants can pose challenges such as whether or not to recruit specific user groups, how many study sites/geographical locations may be needed to achieve a full recruit, and how to establish inclusion and exclusion criteria to ensure safety of all in attendance at the in-person study.
Each company should evaluate likely participant vulnerabilities and possible coronavirus exposure to assess whether the users can safely attend the study. Carefully consider user characteristics such as compromised immune system, conditions linked to higher risks related to COVID-19 (such as diabetes, obesity, asthma or other lung and cardiovascular conditions, etc.), healthcare professionals involved in the care and treatment of patients with COVID-19, etc. There may be difficulty finding representative participants, particularly user groups with higher risks. When planning recruitment of potentially challenging user groups, consider if it may be necessary to divide user groups across multiple geographic locations to recruit the desired sample size.
During recruitment and upon arrival to the study, additional screening may be necessary to exclude any participants who may be experiencing symptoms of COVID-19, have been exposed to the coronavirus, or potentially even live with someone who might be at higher risk to the coronavirus due to existing conditions or comorbidities. Recruitment screeners and informed consent forms should all reflect coronavirus information (including COVID-19 exclusion criteria) to ensure the safety of all involved.
COVID-19 Safety Management Plan For Study Conduct
For any in-person HF study, modifications to typical processes, such as moderator-participant interactions, are expected during the pandemic. A documented coronavirus safety management plan will be essential to your HF study conduct. The plan will assist study personnel and project management with executing studies safely and clearly communicating expectations for safety. For example, Agilis has developed, implemented, and properly vetted our own coronavirus management plan for conducting remote and in-person research, for both formative evaluations and validation studies. For each project, Agilis works with the client to incorporate any client-specific coronavirus requirements for study conduct into the management plan. If your study requires IRB approval, confirm what the IRB’s expectations are regarding conducting studies during the pandemic, as each IRB may have different COVID-19 safety documentation requirements for the overall IRB submission.
On-Site Logistics
Diving a little deeper into logistics and safe study execution, there are several things that sponsors should consider when preparing to conduct in-person studies:
Looking ahead and what’s next for HF programs
It is unclear how soon we can expect to return to typical HF program strategies and activities. Companies cannot perpetually delay HF programs until the pandemic is over – the pandemic shows signs of being here for the long term. Because of the constantly changing situation and the unknown timeline, we encourage you to plan ahead for various scenarios so that your HF programs can keep moving forward and patients and end users can ultimately benefit from your new products as quickly as possible. Agilis has been carefully conducting in-person studies since June, and we can offer guidance as you plan your HF activities to support your larger HF program. While the path forward may be daunting during this pandemic, there are always ways to move your HF program forward!
About the Author:
Renee Bailey
Renée is an industry thought leader and an active conference speaker on topics related to human factors engineering and regulatory requirements, evidence-based instructional labeling and training, post-market surveillance, and processes related to medical product clearance, approval and global market success. She also serves as Faculty for AAMI’s human factors course, Applying Human Factors to Improve Instructional Materials as Part of the User Interface. Renée is an expert in applying a scientific, systematic and scalable methodology based in Human Performance Technology (HPT) to produce effective instructional materials for healthcare professionals, lay user patients and caregivers, and clinical educators.