Changing the protocol: a case report from the Macular Photocoagulation Study. Macular Photocoagulation Study Group.
The first report of findings from the Senile Macular Degeneration Study (SMDS), one of several clinical trials carried out by the Macular Photocoagulation Study (MPS) Group, appeared in June 1982. Although the SMDS did not terminate with the change of protocol that precipitated release of the initial findings of the trial, activities prior to and immediately following the decision to halt recruitment and publish findings were disruptive to the operations of all centers and to the professional and personal lives of the individuals with greatest responsibility for implementing the change. The purpose of this report is to describe the experiences of the MPS investigators in the hope that others may learn from them. The issues that confronted the investigators are discussed. The decisions they made, a chronology of events, and activities leading to the decision to terminate patient enrollment in the SMDS and to release findings from the trial are described.
D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods*; D003142:Communication; D003657:Decision Making; D004992:Ethics, Medical; D006801:Humans; D007834:Lasers; D008028:Light Coagulation / Q000009:adverse effects*; D008268:Macular Degeneration / Q000601:surgery*; D012107:Research Design; D014792:Visual Acuity