Details

Autor(en) / Beteiligte

• Marks, Jay W.
• Croke, Gloria
• Gochman, Nathan
• Hofmann, Alan F.
• Lachin, John M.
• Schoenfield, Leslie J.
• Tyor, Malcolm P.

Titel

Major issues in the organization and implementation of the national cooperative Gallstone Study (NCGS)

Ist Teil von

• Controlled clinical trials, 1984-03, Vol.5 (1), p.1-12

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

1984

Link zum Volltext

Quelle

Elsevier Journal Backfiles on ScienceDirect (DFG Nationallizenzen)

Beschreibungen/Notizen

• The National Cooperative Gallstone Study (NCGS) was a cooperative, randomized, controlled trial of a drug, chenodiol, for the medical dissolution of gallstones. The design and procedures of the NCGS were complex, having developed as a result of extensive involvement of many experts in the field of gallstone disease and biliary lipids. During the design and implementation of the protocol, many important issues required consideration and resolution. The aim of this article is to review these issues and the deliberations surrounding their resolution and provide personal conclusions and recommendations that may be helpful to other investigators, involved in cooperative, controlled trials.