| Abstract | Several factors constrain the implementation of Randomised Controlled Trials (RCTs). To obtain large
sample sizes a multicentred multinational trial may be necessary or a long sampling period. The larger the
trial the larger is the unit cost. To allow larger sample sizes, shorter sampling periods and lower unit costs,
new methods are needed. The Internet and in particular the WWW provides such an opportunity. The
WWW can provide global access, fast interaction and automation. A prototype Internet Trials Service (ITS)
is currently being tested with a real international clinical trial (the Growth Restriction Intervention
Trial--GRIT). The ITS is hosted on a Web server. It provides a series of HTML documents that describe
the GRIT protocol. Registered centres may enter patients into the GRIT trial via ITS. Java applets are used
to collect trial data before returning the study number and randomisation. ITS assumes all trial data will be
intercepted by a sniffer. Therefore no information is sent that could specifically identify a patient, this must
be sent later by more secure means. ITS assumes that trial centres can be spoofed. To authenticate the
patients entered into the trial and the trial data sent, a regular audit report is sent to each centre by secure
means for confirmation. By using Java, a full functional data entry system can be developed that runs locally
within any Java enabled browser. It can perform data validation locally and also provide a sophisticated user
interface. |