Jornal de Ensaios Clínicos
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Assessing Clinical Trial Technology: Evaluating the TIME Study

David A. Rorie, Thomas M. MacDonald, Amy Rogers and Robert W.V. Flynn

Purpose: Electronic data capture has quickly become the preferred means of capturing and storing clinical study data. Cost and efficiency savings have been documented, yet it is unclear how acceptable this technology is to participants. An evaluation survey has been created to assess participant attitudes to a clinical study website.
Methods: The TIME study is a clinical study that uses an online methodology to compare morning dosing of hypertensive medication with evening dosing. An evaluation questionnaire was developed and sent to participants to assess their views of the online methodology. The final questionnaire was organised into themes: functionality, personal contact, and trust. Negative and positive phrasing was used along with a Likert-type scale. The survey underwent 4 iterations before the content was finalised.
Results: 149 responses were received from 263 invitations. The mean scores for the three themes in the final 14 item questionnaire were as follows: functionality, 3.99; personal contact, 3.89; and trust, 4.03; suggesting an overall positive perception of the study methodology. Concerns regarding use of data and privacy were present in the responses but the overwhelming majority of responders chose to take part due to a sense of altruism and recognising the need for clinical research.
Conclusion: This questionnaire was specifically created to evaluate the TIME study website. Additional improvements to the questionnaire are necessary for more general usage. The feedback provided from participants reveals areas of the study website that require further development, and has reaffirmed known concerns participants have about the use of their data.