Читать книгу Randomised Clinical Trials - David Machin - Страница 129

Before entering patients on the study, clinicians must ensure that the protocol has received clearance from their local Ethics Committees. The patient’s consent to participate in this trial should be obtained after full explanation has been given of the treatment options, including the conventional and generally accepted methods of treatment, and the manner of treatment allocation.

All the possible options on trial should be explained impartially to the patients concerned. This explanation must be provided before the randomisation is realised as knowledge of the assignment may influence the way in which an investigator explains the alternatives. A key feature of the informed consent process is to explain the randomisation procedure and to emphasise that participation is completely voluntary and that the patients can withdraw from the protocol at any time.

As is often the case, new challenges arise and the 2020 COVID‐19 pandemic has had a profound and immediate impact on the conduct of clinical trials. Even without the lockdown and the introduction of circuit breaker in place, due to the infectious nature of the corona virus, it was deemed that the risks would be too high to continue with research activities requiring face‐to‐face contact. As a consequence, in a proposed cluster randomised trial to be conducted in Singapore on the safety and efficacy of hydroxychloroquine in households with index COVID‐19 cases, the study team proposed to contact those concerned via telephone to assess their interest to participate in the clinical trial. At the same time, the email address of the household contact would be obtained. Once the eligible participant had ample time to read the electronic informed consent form (e‐ICF), the study team would conduct the informed consent discussion via video consultation. If the subject then wished to take part in the trial, he/she would be required to digitally sign the e‐ICF using Docusign, in the presence of an impartial witness during the video consenting process.