Nikolajs Zeps|Nicholas Northcott|Leanne Weekes
Opportunities for <scp>eC</scp> onsent to enhance consumer engagement in clinical trials
Epworth Hospital
enhancing clinical trial recruitment econsent potential needs evidence use consent medical interventions clinical research participation currently relies use printed information combined conversation health care professional largely undocumented studies shown participants truly informed using traditional means demonstrated recall comprehension disclosed poor13 attempts develop standardised participant information consent forms picfs meet ethical requirements often resulted longer complex documents consumers engaged assist programs purpose picfs still heavily weighted toward satisfying regulatory requirements rather patient information needs unsurprisingly data show picfs get longer less well understood4 5 evidence one reasons patients agree participate clinical research6 econsent simply conversion paper picf electronically delivered version also holds promise improving participant engagement clinical trials variety features include use econsent replace opportunity participants ask direct questions doctor investigators moreover instances participants still required make physical visit clinic receive treatment whereupon ask questions confirm willingness participate relatively studies using econsent early randomised controlled study preference econsent well improved comprehension intention participate people assigned use computer terminals rather paper receive information7 recent study involving people infected human immunodeficiency virus8 econsent found acceptable advantages paper information sheets majority males included study 75 half african american mix sexual orientation health literacy participants factor emerged impact comprehension however number participants n 20 small draw statistically sound conclusions 2013 study tested comprehension satisfaction using ipads deliver information neuropathy chemotherapy study9 importantly investigators presented information formats ipad initial video outlining main features study found 55 patients took part randomised study statistically significant association increased comprehension group assigned ipad sample sizes small definitive findings interest use ipad increase likely participation rates slightly lower participants advised information provided still complex regardless media used simplified text diagrams animations ways enhance comprehension needed recent study reported transcelerate econsent initiative employed large survey 3045 participants number smaller stakeholder consultations10 general support potential participants use econsent survey revealed people living european union greatest level discomfort survey also found people concerned econsent might eliminate siteparticipant discussion regarding participation even though case actually used australia widespread use econsent date better understand australian context clinical trials impact quality ctiq cooperative funded mtpconnect australian government industry growth centres initiative using funds federal governments medical research future fund mrff set investigate stakeholder perceptions econsent therefore identify potential actionable insights chrysalis advisory developed survey sent via email members ctiq distribution wider clinical trial sector first quarter 2019 total 179 participants completed survey used snowball methodology denominator persons polled addition 19 semistructured interviews conducted drawn ctiq membership majority respondents 68 women 75 aged 40 years 80 10 years working trials demonstrating considerable experience sector full report available website11 questions presented pages 5859 report key findings summarised box specifically surveyed deploying econsent stage end users wished understand sector already perceived barriers opportunities although 292 respondents indicated direct experience econsent survey revealed overall cautiously positive toward use econsent important finding optimism use electronic formats would enable participants drive informationseeking process way best suited needs physical infrastructure particularly public hospitals widely held adequate support econsent uptake wifi blind spots within hospitals cited major reason well difficulties achieving infrastructure updates within public health system respondents recommended approaches econsent employ technologies rely expensive infrastructure delivered health services addition respondents indicated ideally sectorwide standard site information technology infrastructure requirements combined clear guidance sponsors standardise approaches number interviewees worked trials econsent sponsors provided devices noted devices clunky prone malfunction increased overall study time burdened trial staff clinical trial sites often experienced sponsors insisting standards resulting unnecessary duplication incompatibility instrumentation sites many respondents cited differences use econsent platforms inconsistencies organisations regarding econsent compliance eg whether participants would required sign electronically would able consent using technologies face recognition fingerprint identification etc made difficult adjust use econsent greater industry engagement collaboration may mitigate barrier providing stakeholders frameworks support implement econsent furthermore setting national guidelines facilitate design regulatory approval implementation strategies adopt econsent stakeholders identified data security risk associated econsent others believe security threats greater similar threats existing digital technologies use throughout clinical trials medical field broadly suggested appropriate security systems place data governance risks managed stakeholders likely concerned data governance risks econsent using econsent automatically mean participants ability provide consent offsite simply access information offsite different participants providing wet ink signatures offsite terms risk fact person comes clinic accepts study treatments clear demonstration consent twofactor authentication processes enabled econsent may provide robust means authenticate consent current paperbased processes surprising econsent considered add cost burden paperbased approach however respondents considered cost savings made enabling prior reading relevant documentation particular major cost savings site participants could potentially deliver respondent large cancer centre articulated potential benefits outlining participants anywhere outside 50 km radius tertiary centre could avoid additional time needed clinic able use econsent centre piloting teletrial model deliver trials nontertiary settings recognises econsent pivotal enabling model promises reduce burden patients reducing need travel ensure clinical trial participation available beyond metropolitan centres appears survey australia willing partially ready implement econsent pathway forward require proactive planning leading managing organisational change creation practical demonstration cases development delivery use econsent clinical trial setting vital support wider adoption ctiq looking program undertake pilot projects part initiatives enhance clinical trial capability across australia jurisdictions clinical trials impact quality ctiq cooperative funded mtpconnect australian government industry growth centres initiative using funds federal governments medical research future fund relevant disclosures commissioned externally peer reviewed