Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project

Abstract

While efficient methods of communication are known to be essential in conducting large multicenter clinical trials, very little information is provided on actual methods that can be implemented to improve communication. An integrated technology-based communication system was developed for the Sequenced Treatment Alternatives to Relieve Depression (STAR^*D) project, which prospectively defines treatments that are most effective for participants with a diagnosis of a nonpsychotic major depressive disorder (MDD) who report an unsatisfactory clinical outcome to an initial and, if necessary, subsequent treatment(s). This web-based communication system is comprised of a multi-faceted study Web site, including a help desk, document sharing, a project directory and reports. In addition, automated reporting via e-mail and an online data correction mechanism are also available. The STARD communication system improves communication between study personnel and improves the quality of the study's data through the integration of system elements, the integration of those elements with traditional forms of communication, by filling the gaps not addressed by those traditional methods and by reducing the staff workload burden.

References

1. Meinert CL . Clinical trials: design, conduct, and analysis. New York and Oxford: Oxford University Press, 1986.

2. Kennedy C , Kirwan J , Cook C , Roux P , Stulting A , Murdoch I . Telemedicine techniques can be used to facilitate the conduct of multicenter trials. J Telemed Telecare 2000; 6: 343–347.

3. O'Brien B , Nichaman L , Browne JEH , Levin DL , Prorok PC , Gohagan JK for the PLCO Project Team . Coordination and management of a large multicenter screening trial: the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial. Control Clin Trials 2000; 21: 310S–328S.

4. Meinert CL . Multicenter trials and travel: luxury or necessity? Control Clin Trials 1990; 11: 399–401.

5. Margitic SE , Miles NL . Ten commandments of successful trial management. Prev Med 1998; 27: 84–92.

6. Santoro E , Nicolis E , Franzosi MG . Telecommunication technology for the management of large scale clinical trials: the Gissi experience. Comp Methods Prog Biomed 1999; 60: 215–223.

7. Curb JD , Ford C , Hawkins CM et al. A coordinating center in a clinical trial: the hypertension detection and follow-up program. Control Clin Trials 1983; 4: 171–186.

8. Marley JE , Snaith J . Does communication between investigators improve the conduct of the multicenter study? Br J Clin Psychiat 1989; 43 158–160.

9. Williams OD . A framework for the quality assurance of clinical data. Clin Pharmacol Ther 1979; 25: 700–702.

10.

10. Warlow C . Organise a multicenter trial. Br Med J 1990; 300: 180–183.

11.

11. Fuller RK , Mattson ME , Allen JP , Randall CL , Anton RF , Babor TF . Multisite clinical trials in alcoholism treatment research: organizational, methodological and management issues. J Studies Alcohol 1994; 12: 30–37.

12.

12. Naydeck BL , Sutton-Tyrrell K , Burek K , Sopko GS . Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: a multicenter clinical trial. Control Clin Trials 1996; 17: 226–234.

13.

13. Dorman K , Saade GR , Smith H , Moise KJ Jr . Use of the World Wide Web in research: randomization in a multicenter clinical trial of treatment for twin-twin transfusion syndrome. Obstetrics Gynecol 2000; 96: 636–639.

14.

14. Santoro E , Nicolis E , Franzosi MG , Tognoni G . Internet for clinical trials: past, present and future. Control Clin Trials 1999; 19: 194–201.

15.

15. Rush AJ , Fava M , Wisniewski SR et al. Sequenced treatment alternatives to relieve depression (STARD): rationale and design. Control Clin Trials 2004; 25: 118–141.

16.

16. Fava M , Rush AJ , Trivedi MH et al. Background and rationale for the Sequenced Treatment Alternatives to Relieve Depression (STARD) study. Psychiat Clinics North Am 2003; 26: 457–494.