Frequency and causes for exclusion from randomization of healthy volunteers screened for a phase 1 study in India.
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2012-01
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Abstract
Background. Only a proportion of screened potential
participants were actually randomized while conducting a
phase 1 study of a humanized rabies monoclonal antibody. We
aimed to assess the challenges in defining who is a normal
volunteer and the issues that affect volunteer recruitment and
thus accrual.
Methods. One hundred and fifty-six volunteers were
screened and 74 (47.4%) were randomized in a phase 1 study.
Data on all participants screened for the study were analysed and
reasons for their non-randomization were classified.
Results. The reasons for volunteers not being randomized
were: (i) deranged laboratory parameters (n=62); (ii) nonlaboratory
causes (n=4); and (iii) withdrawal of consent
(n=16). A large proportion of screen failures were due to low
haemoglobin levels, which led to the protocol being amended
midway during the study. An informal interview of those who
declined consent showed that they had only wanted to get
themselves investigated thoroughly or were interested in
getting their HIV status evaluated.
Conclusions. Our study shows that <50% participants screened for a phase 1 study in a developing country actually get randomized. The main reason for non-randomization is abnormal laboratory tests. This may help investigators and sponsors to plan protocols better, define normal ranges with acceptable variations based on their own populations a priori and have more pragmatic accrual targets.
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Gogtay N J, Thatte U M, Kulkarni P S. Frequency and causes for exclusion from randomization of healthy volunteers screened for a phase 1 study in India. National Medical Journal of India. 2012 Jan-Feb; 25(1): 18-20.