The Covid-19 pandemic has brought in unique challenges to the clinical trial industry world over. Overall there have been substantial changes to healthcare access, health risks and daily interactions causing concern over the conduct of clinical trials during this period. The government bodies have greatly restricted the movement of public, by enacting laws to ensure that the public stays home. However, the recent FDA guidelines urge sponsors to assure the safety of clinical trial participants to maintain compliance as well as minimise on the risks caused to trial integrity during this pandemic. Although, the first response to the pandemic was on temporarily putting most of the ongoing clinical trials on hold and postponing the clinical trials which were at the start-up phase, today Clinical Trial Managers are working resiliently towards redesigning clinical trials into home based clinical studies which could bring in a paradigm shift to the industry.

Home-Based Clinical Trials: Can it Offer the Right Solution? Being able to conduct home-based study visits has a number of real benefits. It not just helps study sponsors to slim costs, but the real benefit is passed on to trial subjects who can take part in the studies from the comfort of their homes. A best case scenario in this pandemic is that patients’ safety can be observed by minimising travel. Thus, home visits by the study team, takes away the fear from public who are reluctant to travel to sites unnecessarily.

Clinical Trial Managers have been working resiliently to make key decisions, assess risks and redesign trial processes at this time. Thus, to avoid compromising on safety, the concept of home-based clinical trials have been embraced as the most practical step towards data collection and management of on-going trials, which would help maintain data integrity during this pandemic, as well as show preparedness for any future catastrophe.

Home based clinical trials support patients by reducing the visits to sites especially for patients who require assistance of a care-giver. In addition, some patients are too busy with their schedules and find it difficult to travel to sites frequently, while others are reluctant to visit hospitals or the sites since they are very far away, for instance, in the case of rare diseases, where finding a site nearby is not easy.

3H Conducts Survey in Japan to know the Public Interests on Home Based Clinical Trials: 3H conducted an online survey on the Seikatsu-Kojo website in January 2021 to understand the public interests in Japan for home based clinical trials. 3933 participants took part in this study and a majority of the participants had a positive intention towards participating in home based clinical trials with 25.2% of the respondents claiming it to be very good, while another 38.7% said it was a good idea. Thus a majority of 63.9% were very keen on participating in home-visit clinical trial initiatives. The purpose of conducting this survey during this pandemic period was to understand the views of the Japanese in participating in clinical trials which are home based. In these home based clinical trials, the study staff would visit the homes of the trial subjects so that the spread of Covid-19 can be minimized in the vulnerable categories of people. Currently, it is rare for all clinical trials visits to be conducted from homes, rather it is a combination of site and home visits. Only less than 10% of the population did not like the idea of home based patient visits. The feedback from this survey would greatly help to improve the quality of home based study visits and render to meet the expectations of the subjects.

An Insight into the Survey: The survey was a representation of both the urban and rural Japanese population with 51.4% being women and 48.6% being men. The largest age distribution included those between 50 to 59 years followed by the age category of 40-49 years. 33.5% of the respondents were employed, followed by 15.8% being part time workers. The majority of participants that is 59.5% were living with their spouses. It was interesting to note that the young crowd were more willing to participate in home based clinical trials than the older generation. It was observed that negative responses such as ‘I don’t want to participate at all’ increased with the age, showing that the elderly population must be more informed on the benefits of home-based clinical trials.

There were many bonus points which were highlighted by the participants as benefits from home based clinical trial conduct. Many enjoyed the fact that they could relax at home and that there was no wait time or hospital travel time, while also helping to lessen their concern about contacting Covid-19. Time is an aspect which is highly valued by subjects, and the fact that home visits, saved their time was a very positive indication towards agreeing for home based visits. Some of the concerns which were highlighted for home based visits included, if the same level of service given at hospitals would be received by trial subjects. There were also concerns on what kind of study team members would be treating them as well as general concerns about privacy and security. Many also found it to be an additional burden to prepare in welcoming guests home and having to clean homes for the occasion, which would consume time. The elderly were also worried if the visits could be done with the same level of competency, due to the lack of suitable medical equipment for any additional tests if the need arises.

More than 80% participants preferred to have a visit at least once a month with about 24% agreeing to have visits twice a month. Also it was noted that the frequency of the visits became irrelevant among the young crowd and they preferred to have a visit completed within an hour with shorter visit times being more preferred.

Why Should More Home Visits be encouraged? With this pandemic, clinical trials too have taken a hit. Had home-based clinical visits been more popular and implemented in the past, then there would not have been a delay in getting the clinical trials rolling at present. Home visits would help the clinical trials to function as site-less where the studies could be controlled and monitored through a central point of contact. It would greatly reduce the huge investments into infrastructure development and cut down on costs for the sponsors.

In addition, as the majority of people have shown in this survey, home visits would be a great option for them to save on time. This is especially true even for rural Japan, where participants have to travel far to reach a study site. Home visits would help them to have the visit done from the comfort of their home. The pandemic has made us to redesign the structure of clinical trials and the future of the industry would shift towards, home based and virtual clinical trials.

As a pioneer into the clinical research industry, this initiative taken by 3H to know the public pulse on home based clinical trials would be a great insight for sponsors and site staff. Further, the public feedback, will help to improve the structure of these home-based clinical trials which would help to improve subject satisfaction levels and ensure the smooth conduct and retention rates of the participants.