How we maintain safety and quality in clinical trials

Reading Time: 3 Minutes
20.05.2020

Safety is an important topic and one that is widely discussed at the moment. Our clients' safety is always our primary concern; however, with the current pandemic we have even more things to consider and precautions to take. Depending on where you live, you might not be seeing any clients at all or maybe you can see clients when following strict distancing rules. In whichever circumstances you find yourself, we wanted to take this opportunity to expand on the topic of safety, specifically regarding clinical trials.

The safety and wellbeing of our test clients

When performing clinical trials, the wellbeing of the test clients is a key element and the reason that international standards have been created for investigations involving human subjects (European Medicines Agency, 2016). The welfare of the test clients seems like something obvious that we wouldn't have to remind ourselves to consider. We would never endanger our test clients, but when running clinical trials there is an inherent risk associated with any new product. While, the risks of hearing aids are known and of a low grade, the safety and wellbeing of the test clients is not something that can be taken for granted.
Having a trial reviewed and approved by an ethics committee confirms that the trial has been designed to expose the test subjects to the minimum amount of risk necessary to test the new product. This means that the benefits of testing and using a new device outweigh the potential risks. Furthermore, the ethics committee makes sure that the testing procedures are within reasonable limits of what subjects should be expected to complete.

The first step before any others

The most important step before any test procedures can begin is the signing of the information and consent form. All potential test subjects must read the information and consent form which contains the details about the trial before they agree to participate. The information includes any possible risks they could incur from using the devices and describes the testing activities that they are expected to fulfill.

stack of files

How many test clients and tests are useful?

The trial should not use more clients than absolutely necessary to complete the trial. A sample size is always calculated to determine the minimum number of subjects needed for each trial. They should also not be obliged to attend excessive clinic appointments which should, additionally, not be too long but should be designed in an efficient manner. Normally lab tests for hearing aids don't seem like they'd be too demanding. But when designing a trial, it's easy to get carried away with all the possible tests that could be useful. It's important to remember the client, who must sit in the sound-proof booth and answer speech tests for an hour. Longer durations of testing cause mental and even physical fatigue, not to mention how sleepy it can make the person giving the test – speaking from personal experience.

What are adverse events?

Adverse events (AEs) are things that occur during the trial but not necessarily during the testing itself such as headaches, falls, and illnesses. They may or may not be related to the tested device, but all AEs must be reported. Subjects often need a lot of prompting to get them to remember some of these events, but it's important for tracking their safety and could in fact uncover a new risk caused by the device that was previously unknown.

Bernafon products are tested at a high standard

As you can see, even for a low-risk device that is used by millions of people, there are still many things to consider in order to protect the wellbeing of test clients. Our next trial will involve further steps to minimize clients' exposure to all types of risks especially since many of them are vulnerable to things such as highly contagious viruses. Thanks to our volunteer participants, who donate their time and energy, Bernafon products are tested at a high standard of quality to ensure their safety and effectiveness before being released to the market. Please see the TiA: Good Clinical Practice – Maintaining safety and quality for more details about clinical trials performed at Bernafon.

REFERENCES

European Medicines Science Medicines Agency (2016). Guideline for good clinical practice E6(R2) Addendum Step 5 Version, 5-69. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf Accessed on 28 April 2020.

 

About the author:

Julie Tantau
Julie Tantau, AuD Doctor of Audiology A.T. Still University, Mesa Arizona, USA. MA Audiology. California State University, Long Beach, USA.
Julie is a Research Audiologist at Bernafon. She contributes to various aspects of the development process including running clinical trials to validate the end product before it’s released to the market. Before moving to Switzerland to work for Bernafon in 2012 she worked as a Clinical Audiologist in the United States treating patients with hearing and balance problems. In her private time, Julie enjoys baking and travelling with her family.