Objective: Dropouts from clinical trials decrease quality and increase cost
s. Free participation, paid participation, and contingency contracting are
three study retention methods. Contingency contracting, or depositing a fee
to be refunded contingent upon attendance in a clinical trial, has been re
ported to decrease dropouts without affecting weight loss. These three meth
ods of retention were compared with a commercial weight loss clinic's pract
ice of charging non-refundable fees.
Methods and Procedures: Dropouts were compared in two studies testing mazin
dol, with one study using free care and the other using contingency contrac
ting; two studies testing phenylpropanolamine, one using free care and the
other using contingency contracting; and in studies with phenylpropanolamin
e on file with Thompson Medical Company using free care, paid participation
, and contingency contracting.
Results: The dropout rate was 50% at 8 weeks in a trial of mazindol with fr
ee care vs. 7% for contingency contracting (p<0.001). The two phenylpropano
lamine studies gave the same weight losses, but the dropouts were 37% at 8
weeks for free care vs. 11% for contingency contracting (p<0.001). The stud
ies of phenylpropanolamine on file at the Thompson Medical Company had 28%
dropouts at 8 weeks using free care vs. 19% for paid participation (p<0.001
), and 11% for contingency contracting (p<0.005). Dropouts with contingency
contracting (11%) were not different from the commercial weight loss progr
am (13%).
Discussion: Contingency contracting can decrease dropouts, improve quality,
and decrease costs without affecting weight loss in clinical trials for ob
esity.