Can Clinical Trials Be Done on the Internet?

The Internet offers opportunities for studying some treatments quickly and effectively, according to a feasibility trial published in the British Medical Journal.

There appear to be limits to the usefulness of the method explored, however. The study, conducted by rheumatology staff at the at the Tufts-New England Medical Center, Boston, suggested that the Internet-based approach was most appropriate when the intervention on test is safe, the medical disorder can be confirmed by remote means, and the outcome measures can be applied by using electronically controlled technologies.

The study looked at a 14 week placebo controlled randomised trial of glucosamine for knee pain. Patients applied to join the trial online via a specially designed website and were asked to log on every two weeks to complete questionnaires. They were prompted to respond by automated e-mails and personalised schedules. Adverse effects could be reported at any time via the website, e-mail or toll-free phone call.

Over 1200 people responded to the study and 205 were recruited of whom approximately 80% completed the trial. A post-trial survey found that most had a positive view of the trial and would be happy to participate in another in the future.

A cost comparison suggested that the Internet based approach cost about half that of a hospital-based trial, though the authors say a more formal cost comparison should be done. The difference was driven by the need in hospital trials for clinical space, nursing time, participant travel reimbursement and data entry costs.

The significance of the trial lies in its use of the Internet as almost the sole means of communication. Recruitment to trial and online capture of data have been described before, but few researchers have attempted to integrate these online components into a single process and the authors say no previous study has evaluated the performance of such an endeavour.