IVF with preimplantation genetic screening, a promising new treatment with unexpectedly negative health outcomes: the Hippocratic role of Data Monitoring Committees.
A recently published randomized controlled trial showed preimplantation genetic screening (PGS) as part of an IVF programme to reduce ongoing pregnancy rates by 1/3 in comparison to the control group without PGS: rate ratio (RR) 0.69 (0.51-0.93), P = 0.01. A masked interim analysis already showed significant differences between treatment arms: RR 0.58 (0.35-0.94), P = 0.02. Despite this finding, the trial's Data Monitoring Committee decided not to stop, but to continue the trial. This paper argues why this decision was sound, since it was based on (i) explicit statistical criteria and (ii) the trade-off between risks and benefits for current and future IVF patients. The trial's findings confront the medical community once again with the general problem of new technologies being implemented without randomized evidence of effectiveness.
Ankum
Willem M
WM
Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, The Netherlands.
Reitsma
Johannes B
JB
Offringa
Martin
M
D001723:Birth Rate; D026661:Clinical Trials Data Monitoring Committees; D004311:Double-Blind Method; D005260:Female; D005307:Fertilization in Vitro; D006801:Humans; D015337:Multicenter Studies as Topic; D011247:Pregnancy; D018873:Pregnancy Rate; D019836:Preimplantation Diagnosis / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment