Conducting clinical trials over the internet: feasibility study

Researchers found that conducting trials over the internet can offer opportunities for studying treatments quickly and efficiently.

The possibility of conducting clinical trials on line is a relatively unexplored application of the internet. To be appealing, online trials need to be feasible, efficient, and valid. In this trial, more than 1200 people applied on-line to take part in a trial of glucosamine in osteoarthritis of the knee (see breaking news article on this site). Of the 205 participants randomised, approximately 80% completed the trial. Researchers found it is clearly feasible to do certain types of randomised placebo controlled trials over the internet. They were able to solicit and authenticate applicants and to conduct the internet based trial with adherence and retention rates comparable to those of trials done in traditional settings. Furthermore, most of the participants had a positive view of the trial and would be happy to participate in another such trial in the future. The trial was efficient with respect to the application rates, direct data entry, short time to database lock, and minimal staffing levels. On the other hand, the time taken to obtain consent and medical records limited the speed of enrolment. These were two aspects that were not internet based. Although the large number of applicants offset the delay, it could be improved by measures to circumvent the need for paper documents and medical records. External validity is a common problem for traditional trials, owing to restrictive eligibility criteria and selection biases in hospital based settings, whereas the internet based approach allows participation from the home or workplace. In either case, the problem needs to be tackled by an adequate description of the setting and sample characteristics.Researchers concluded that further explorations may be needed to determine to what extent their findings can be reproduced for other interventions and medical disorders. On the basis of current knowledge, they suggest that the internet based trial method is most suitable when the intervention is safe, the medical disorder can be confirmed by remote means, and the outcome measures can be applied by using electronically transmissible technologies. Within these parameters, the internet trial method offers opportunities for studying treatments quickly and efficiently. (Source: BMJ 2003;327:484-487: November 2004.)