The New England journal of medicine
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Randomized Controlled Trial Multicenter Study
Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease.
A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses. ⋯ Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up, the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group. (Funded by Sanofi Pasteur; ClinicalTrials.gov numbers, NCT00842530, NCT01983553, NCT01373281, and NCT01374516.).
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Multicenter Study
Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma.
Multiple myeloma cells uniformly overexpress CD38. We studied daratumumab, a CD38-targeting, human IgG1κ monoclonal antibody, in a phase 1-2 trial involving patients with relapsed myeloma or relapsed myeloma that was refractory to two or more prior lines of therapy. ⋯ Daratumumab monotherapy had a favorable safety profile and encouraging efficacy in patients with heavily pretreated and refractory myeloma. (Funded by Janssen Research and Development and Genmab; ClinicalTrials.gov number, NCT00574288.).
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Randomized Controlled Trial Multicenter Study
Intravascular Complications of Central Venous Catheterization by Insertion Site.
Three anatomical sites are commonly used to insert central venous catheters, but insertion at each site has the potential for major complications. ⋯ In this trial, subclavian-vein catheterization was associated with a lower risk of bloodstream infection and symptomatic thrombosis and a higher risk of pneumothorax than jugular-vein or femoral-vein catheterization. (Funded by the Hospital Program for Clinical Research, French Ministry of Health; ClinicalTrials.gov number, NCT01479153.).
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Although in textbooks asthma and chronic obstructive pulmonary disease (COPD) are viewed as distinct disorders, there is increasing awareness that many patients have features of both. This article reviews the asthma-COPD overlap syndrome.
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Study participants who fabricate, falsify, or fail to disclose important information can undermine the integrity of clinical trials, with negative consequences for both future patients and the participants themselves. What can investigators do to address the problem?