Implementing two-stage consent pathway in neonatal trials

Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.

A Virtual Home for the Virtual Clinical Trial

Virtual clinical trials (VCTs) can satisfy the need for rigorous clinical trials by using distributed technological solutions that eliminate the need for a physical trial site. This report explores potential benefits of using virtual reality (VR) to provide a “virtual site” for VCTs, a shared immersive hub in which VCT participants could experience elements of the trial and interact with the trial team. VR is a communication technology that has been emerging alongside the development of VCTs, although they have never been merged in a substantial way. Many of the gaps within the VCT paradigm are areas in which VR excels. VR environments are standardized and precisely uniform, the technology allows introduction of an almost endless set of stimuli to participants’ visual and auditory systems, and VR systems are adept at capturing precise movement and behavioral data. Although VR has not yet found its way into VCTs, much of the groundwork for such integration has been laid through research and technological development achieved in the past few years. Future implementation of VR within VCTs could move us from site-less trials to those with a virtual site serving as a hub for trial information provision, interaction with trial representatives, administration of evaluations and assessments, and more.

Clinical trials in the Coronavirus era: management of risks

The COVID-19 pandemic has caused unique problems facing the clinical trials (CT) community both in terms of the rapid implementation of CTs of COVID-19 drugs and vaccines, and many ongoing non-COVID-19 CTs that are either suspended or adapted to new realities. The CT organizers have played a key role in decision making, risk assessment and adaptation of trial processes, working side by side with other members of the trial team. Regulatory authorities (FDA, EMA, Ministry of Health of Russia, etc.), which issued initial recommendations for adapting the clinical trial methodology to new conditions as far back as March 2020, and then later on, generalized the experience in the management for clinical trials. The recommendations made based on the reviewed experience can help all CT parties to cope with the risks associated with both COVID-19 itself and anti-epidemic measures in different countries of the world with minimal losses.