The last two years of the Pandemic have greatly changed both our personal habits and working practices. A heightened sense of social distancing, a focus on hygiene, working from home, flexible working hours, remote learning, virtual meetings, and webinar attendance are just some of the activities that have been brought into focus. A lot of industries have had to adapt and embrace novel arrangements, and as a result, the way clinical trials are conducted has changed significantly.

Remote trials

Remote trials (also called virtual trials) are trials that primarily capture data remotely – that is, participants will log into a platform to enter data, or have video calls with their trial site. This has the benefit of allowing people to take part even if they live far from a trial site and they have become much more common since 2020. It’s important that trials continue, so that consumers are allowed access to better treatments and quality products. Due to COVID-19, study protocols have seen a big shift from requiring face to face visits to allowing ‘at home’ assessments. The main reason for this is reducing the risk of spreading the virus by adhering to travel and site capacity restrictions, and even if these are relaxed, it also allows individuals to take part if they are reluctant to travel for health reasons. 

Electronic Data Collection 

Remote trials are not always possible, as some objective assessments may require instruments that are only available at the trial site. However, in recent years new technology has helped develop a number of reliable home devices that enable objective (i.e. instrumental) data collection from home. In other cases, some trials have opted for subjective assessments (i.e. questionnaires or diaries) instead, which can easily be completed at home through different electronic data collection (EDC) systems.

EDC systems have been available for over a decade and before the Pandemic they were considered ‘useful’ in running trials more efficiently and helping trial sites move away from paper data collection. Since 2020, EDC systems have become necessary for running certain trials. Electronic Consent, completing electronic forms, automatic flagging of data, remote monitoring, and finally signing off on forms with electronic signatures as part of a trial is indeed no longer a novelty. The exact features and specifications of the many EDC systems available can be chosen based on one’s needs, budget and regulatory requirements.

No shows, cancellations and dropouts

Participant dropout has always been taken into account when calculating study sample sizes. Prior to the pandemic, dropout rates at our clinical trial site were 10-15% on average. Since 2020 the dropout rate has increased to 20% or more depending on the study. Apart from pre-existing reasons for cancellations and drop outs, increased dropout rates are a result of changing restrictions in place, interactions with people suspected of having COVID-19, or a participant or their close contact developing symptoms such as sore throat, cough or cold, that prevent them from taking part in study visits. These factors can prevent them from attending either as requested by the trial centre or government health regulation or their own responsible decision. The increase in dropout rate has also affected trials conducted from home, as when the participant may be unwell or caring for others they are subsequently unable to comply with study requirements or time commitments. As a result, trial sites have seen their recruitment efforts substantially increased. More time is now spent on recruiting volunteers and more volunteers tend to be enrolled in trials to make up for the potential dropouts.

Study appointments 

Where face to face appointments are required, trial sites have made significant changes to their standard operating procedures for study visits. 

• Staff managing entry of participant and visitors: site staff may be controlling entry to the premises and compliance with entry requirements.
• Appropriate sanitary procedures are in place: trial sites may require QR check in, mask wearing, hand sanitising, temperature check, vaccination certificates based on the procedure in place at the time. Furthermore, between visits, surfaces are wiped down and any apparatus coverings are changed.
• Individual appointments: appointments are scheduled for one person at a time as to eliminate or minimise waiting time at the trial site. Also, participants are advised to inform the trial site of any change in their schedule that may affect their appointment time as to reduce the risk of crowding at the trial site.
• No accompanying person: where possible, participants are advised to come on their own without an accompanying or support person or dependent children.

Vaccination requirements

Where deemed appropriate, some sites may require that study participants have been fully vaccinated to take part in a trial. In NSW for example, trial sites (and other venues) may set their own COVID Safe conditions of entry. It is up to the trial site to exercise judgement on what is appropriate for their premises beyond these regulations, considering the well-being of their staff and trial participants. If visitors or trial participants want to enter premises where the site has chosen to require them to be fully vaccinated, the site staff may ask to see their vaccination evidence. The visitor does not have to show the site staff their vaccination evidence, but if they do not, the site staff can choose not to let them in1. Obviously, this excludes from participation those who decide not to get vaccinated.

Cleaning and sanitising

Procedures to keep trial sites a safe place for staff and participants have been greatly increased. Day to day activities at trial sites now include recurrent cleaning and sanitising of surfaces that are used or touched including sneeze guards, as well as increased use of disposable as opposed to reusable materials. Use of gloves and frequent disposal of waste is also more common than in the past. 

Effect on timelines and budget

Due to the changes imposed by the pandemic, it may seem that trials have become slower (i.e. recruitment, cancellations, individual appointments etc.) and more costly (i.e. more time for recruiting, additional cleaning and sanitizing etc.). However, the pandemic has forced trials to become more efficient by adopting efficient and innovative designs (i.e. virtual trials, flexible schedules) and technologies (eConsent, EDCs, online patient recruitment) that were already available long before COVID-19. What has been lost in terms of time and cost can mostly be regained by adapting to a different, more efficient way of conducting trials that still provide the same benefits and outcomes to clients that wish to conduct studies on their cosmetic products.

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Rules for people in NSW. Rules and restrictions for all people living in NSW. Last updated: 03 August 2022: https://www.nsw.gov.au/covid-19/stay-safe/rules/people-in-nsw