The data management of a phase III efficacy trial of an 11-valent pneumococcal conjugate vaccine and related satellite studies conducted in the Philippines.
BACKGROUND
A large phase III placebo-controlled, randomized efficacy trial of an investigational 11-valent pneumococcal conjugate vaccine against pneumonia in children less than 2 years of age was conducted in the Philippines from July 2000 to December 2004. Clinical data from 12,194 children who were given either study vaccine or placebo was collected from birth up to two years of age for the occurrence of radiologically proven pneumonia as the primary endpoint, and for clinical pneumonia and invasive pneumococcal disease as the secondary endpoints. Several tertiary endpoints were also explored. Along the core trial, several satellite studies on herd immunity, cost-effectiveness of the study vaccine, acute otitis media, and wheezing were conducted.


RESULTS
We describe here in detail how the relevant clinical records were managed and how quality control procedures were implemented to ensure that valid data were obtained respectively for the core trial and for the satellite studies. We discuss how the task was achieved, what the challenges were and what might have been done differently.


CONCLUSIONS
There were several factors that made the task of data management doable and efficient. First, a pre-trial data management system was available. Secondly, local committed statisticians, programmers and support staff were available and partly familiar to clinical trials. Thirdly, the personnel had undergone training during trial and grew with the task they were supposed to do. Thus the knowledge needed to develop and operate clinical data system was fully transferred to local staff.


BACKGROUND
Current Controlled Trials ISRCTN62323832.
Diozele Hazel M
DH
Sanvictores
Marilla G
MG
Lucero
Hanna
H
Nohynek
Veronica L
VL
Tallo
Antti
A
Tanskanen
Leilani T
LT
Nillos
Gail
G
Williams
D000208:Acute Disease; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D016527:Drug Costs; D063025:Health Information Management / Q000592:standards; D006801:Humans; D032521:Immunity, Herd; D007114:Immunization / Q000191:economics; D007223:Infant; D016247:Information Storage and Retrieval / Q000592:standards; D010033:Otitis Media / Q000276:immunology / Q000382:microbiology; D010679:Philippines; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D011018:Pneumonia, Pneumococcal / Q000000981:diagnostic imaging / Q000191:economics / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D011786:Quality Control; D011859:Radiography; D012135:Respiratory Sounds / Q000276:immunology; D013296:Streptococcus pneumoniae / Q000276:immunology*; D013997:Time Factors; D016896:Treatment Outcome; D018074:Vaccines, Conjugate / Q000008:administration & dosage
D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate