Parents' attitudes to children's participation in randomized controlled trials

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

“…This has resulted in cost increases, implementation delays, failure to complete trials, and biased results. [25][26][27][28] Contributing factors to recruitment and retention include lack of trust, inadequate knowledge, fear of side effects and risks, and clinical trial procedures. 25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico.…”

“…25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] In addition, formative research regarding factors related to participation in placebo controlled, vaccine trials is lacking. Therefore, we conducted two studies among adults and children in Puerto Rican municipalities with highest dengue incidence from 2000 to 2009 to assess factors influencing participation in dengue vaccine clinical trials in this population.…”

“…While clinical trials, including vaccine trials, have been conducted in Puerto Rico with children, only one was double blinded and placebo controlled. [18][19][20][21][22][23][24] The difficulty in recruiting and retaining participants in clinical trials is well documented, [25][26][27][28] particularly among children. This has resulted in cost increases, implementation delays, failure to complete trials, and biased results.…”

Clinical trials in children

“…Parents fear assignment of their child to the placebo arm or to the treatment arm which is later proven to be less effective [45,92,93]. This concern may be compensated for by providing the proven effective treatment to all participants at the conclusion of the study.…”

“…The use of pragmatic trials where there are no additional burdens of testing and monitoring beyond the requirements of routine clinical care [37-40] may also alleviate some of these concerns, including the use of placebos [55]. Participation may also be improved by having trained investigators who understand the complexities of conducting trials in children, appropriate facilities that meet the needs of children and a designated trials co-ordinator to facilitate recruitment and trial conduct [45,93,100]. Increasingly the importance of engaging children and families in the recruitment, consent and design of trials has also been recognized [99].…”