Data management procedures in the Asthma Clinical Research Network.

Well-designed data management processes are essential in ensuring the quality of data collected in multicenter clinical trials. This paper describes the data management processes and systems that were developed by the data coordinating center of the Asthma Clinical Research Network. A combination of manual and electronic processes has been designed to process clinical trial data from the point of collection to statistical analysis. A distributed database management system consisting of modular applications for separate data processing activities was developed to enter, track, verify, validate, and edit collected data. In addition, processes for monitoring and reporting data quality are discussed.

Implementing randomization procedures in the asthma clinical research network.

Randomization is a required component for the success of most controlled clinical trials. To ensure that the benefits of randomization are realized, well defined and carefully planned procedures must be put in place prior to the start of a trial. This paper presents a detailed account of the registration and randomization procedures implemented for the first four clinical trials of the Asthma Clinical Research Network.

Genetic analysis in the Asthma Clinical Research Network.

Because there is reason to believe that genetic variants could account for different treatment responses in subjects with asthma, it is important to collect blood for genetic-analysis purposes when conducting clinical trials in asthma. This article describes issues related to maintaining subject confidentiality, tracking and shipping blood samples, quality control procedures at the laboratory performing the genotyping, and necessary data verification checks when implementing the genetic-analysis database for the Asthma Clinical Research Network.

DDI and liver tests in HIV-1 seropositive haemophiliacs.

Many patients with haemophilia who are HIV-1 seropositive are co-infected with the hepatitis C virus with variable degrees of underlying liver disease. To evaluate whether the use of the antiretroviral agent Dideoxyinosine (DDI) causes worsening of hepatic dysfunction as measured by liver enzyme tests, we reviewed our cohort of patients previously treated with monotherapy with Zidovudine (AZT) and subsequently changed to DDI. Seventeen patients (median age: 34 years, median absolute CD4 lymphocyte cell count: 86 cells µL(-1) ) were included in this study. None had coincident use of other hepatotoxic agents. The median duration of treatment with AZT and DDI was 18 and 15 months, respectively. There was no significant change in liver function tests with the use of DDI and no development of clinical signs of hepatotoxicity. Neither duration of treatment, absolute CD4 lymphocyte cell count, pre-existing elevation of baseline aminotransferase levels nor the use of Pneumocystis carinii prophylaxis therapy resulted in further elevation of liver function tests. Monotherapy with DDI was well tolerated in this cohort of HIV-1-seropositive haemophiliacs with coincident hepatitis C infection.