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Challenges of home visits during clinical trials

Clinical trial services

Although home visits are associated with a lot of important benefits, some challenges should also be noted.

Sponsors often link home visits to a higher risk.  Although this is not necessarily the case, certain precautions should be considered. For example data security needs to be a priority.  As many sensitive patient data is transmitted over the internet, additional efforts should be made to limit the possibility of a data breach. It should however be noted that as the younger generations are very liberal in sharing personal information online, the sense of privacy might differ in the future.

Furthermore, a robust system for quality assurance should be in place to assure high quality data.  Logistically, home visits can also pose a challenge.  Instead of having all equipment and personnel at one site, the right person needs to be at the right place at the right time with the right equipment. Therefore, all personnel involved needs to be trained and provided with the proper instrumentation. The integration of home visits should clearly be described in the protocol of the study, so that the Ethics Committee can review all procedures involved. Furthermore, to ensure efficiency, regular reporting of the status of the home visits is recommended.

Also, moving a clinical trial to a patient’s home, can leave the investigator sites feel left out.  Although often sites are trembling under the workload of different clinical trials and they therefore benefit from the added support, they can feel overlooked when more and more of their responsibilities are taken away. However, they should still be taken into account as they will still remain an important stakeholder, especially in the more complex clinical trials. As mentioned before, not all visits can be executed at home. With complex trials come complex visit procedures, involving specific equipment and the need for a medical expert.

Lastly, it is important to note that home visits are not widely accepted yet. For example, in Latin America the regulatory environment is challenging, and the availability of service providers is limited in certain regions, which will make it difficult to implement home visits successfully. Therefore, the local situation should always be taken into consideration before introducing home visits in a clinical trial. Furthermore, although many pharmaceutical companies seem to show some kind of interest in strategies to make trials more patient-centric, a corporate culture cannot be changed overnight.

Although there are still some challenges related to privacy, quality, logistics, etc. the many benefits cannot be ignored. Firstly, an increase in patient enrolment and retention rates will have a positive effect on the results, costs and timelines of a study, benefitting the sponsor. Secondly, the sites involved in a study will be less burdened by the additional workload and therefore have more time to focus on the important task of recruitment. Lastly, although many different stakeholders, all having different interests, are involved in a clinical trial, the patient’s needs should always come first. Having a lower impact on their daily life, a higher chance of being able to participate in a trial and more support during the trial, the benefits of home visits for the patient are undeniable. Therefore, the overall winner of more patient-centric trials, is the patient as, in the end, they will have faster access to new treatments with a lower price.