Each year the Society for Clinical Trials presents an award to the randomized clinical trial published (either electronically or in print) in the previous year that best fulfills the following standards:
- It improves the lot of humankind.
- It provides the basis for a substantial, beneficial change in health care.
- It reflects expertise in subject matter, excellence in methodology, and concern for study participants.
- It overcomes obstacles in implementation.
- The presentation of its design, execution, and results is a model of clarity and intellectual soundness.
TRIAL OF THE YEAR 2012:
The Maternal-Fetal Surgery For Myelomeningocele Trial (MOMS)
The award for 2012 was presented by Catherine Spong, Elizabeth Thom and Jody Farrell at SCT’s 33rd Annual Meeting in Miami. Published in The New England Journal of Medicine in March 2011 (N Engl J Med 2011;364:993-1004).
The MOMS trial compared prenatal versus postnatal surgery for myelomeningocele (spina bifida). The trial was stopped because of superior results with the prenatal surgery after 183 patients had been enrolled (out of a planned 200). The primary outcome of fetal or neonatal death or the need for placement of a cerebrospinal shunt by one year of age occurred in 68% of those undergoing prenatal surgery and 98% of those undergoing postnatal surgery.
The MOMS trial faced great difficulties in recruiting women who had recently received a devastating diagnosis, entailing counseling and providing considerable information and resources about options and ethical considerations. Those randomized to prenatal surgery needed to remain close to the participating clinical center. The effort required to overcome the many obstacles in the conduct of this important trial was a key factor in its selection as Trial of the Year.