Abstract
The Selenium and Vitamin E Cancer Prevention Trial (SELECT) is a randomized, double blind, placebo‐controlled prostate cancer prevention study of 35,533 men from 427 study sites in the United States, Canada and Puerto Rico. Men were randomly assigned to one of 4 treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo) between August 2001 and June 2004. Men were seen at their study site every 6 months for evaluation of medical events, ascertainment of endpoints and dispensing of study supplements.
On September 15, 2008, the Independent Data and Safety Monitoring Committee recommended the discontinuation of study supplements because the alternative hypothesis of no evidence of benefit from either study agent was convincingly demonstrated (p <.0001) and there was no possibility of a benefit to the planned degree with additional supplementation.
In order to refine the estimate of prostate cancer incidence in the 4 arms and to assess the long term effects of the supplements, participants on the trial will continue to be followed. This allows us to complete the previously approved ancillary studies and maintain the cohort for future research. Follow‐up will transition from in‐person study site visits to an annual questionnaire sent by the SELECT Coordinating (previously Statistical) Center. With participant consent, the Coordinating Center will obtain detailed participant contact information for mailing the questionnaire as well as the SELECT newsletters. Medical releases will be obtained to collect additional data on specific endpoints. With approved funding, additional questions may be added to the annual form.
The decision to centralize the follow‐up was due to efficiency of scale and because participants no longer need to be seen to assess acute toxicities or dispense study supplements.
With the change in the follow‐up procedures, many tasks needed to be accomplished in a short amount of time. These included revising the study protocol; development and Coordinating Center IRB approval of a new Informed Consent; defining activities for the final participant visit and training of the local staff for implementation; development of new forms and procedures with a direct participant focus; development of computer applications that move data collection from a web‐based model to a paper‐based model with scannable forms augmented with a web‐based option.
One of the major challenges has been the approval of local IRBs of the protocol amendment and revised Informed Consent allowing the Coordinating Center to directly contact participants. Additional challenges are the loss of experienced trained study site staff with longstanding relationships with participants, training Coordinating Center staff for direct participant contact for answering questions and collecting data via telephone for non‐responders to the questionnaire.
Citation Information: Cancer Prev Res 2010;3(1 Suppl):A85.
