Understanding the Diagnosis and Treatment of COPD and Asthma to Better Inform Site Selection and Patient Recruitment Planning.

There is an increasing worldwide population of people with chronic obstructive pulmonary disease (COPD) and asthma. Mortality from COPD is expected to double over the next 3 decades, making it the third leading cause of death worldwide. It is estimated that as many as 300 million people of all ages and all ethnic backgrounds worldwide suffer from asthma. Devising and implementing a successful strategy for the execution of COPD and asthma trials requires a multifaceted approach, coupled with an understanding of the factors that drive patient recruitment. However, little has been written about recruitment and the comparative success of different recruitment strategies. This paper focuses on results obtained from various assessments of treatment guidelines compliance, patient diagnosis and treatment, approved therapies, and patient profiles that have helped provide insight into critical factors to help drive country, site, and patient recruitment strategies.

Short-term reactogenicity and gender effect of anthrax vaccine: analysis of a 1967-1972 study and review of the 1955-2005 medical literature.

PURPOSE: In the 1960s, the Centers for Disease Control and Prevention (CDC) held the investigational new drug (IND) application for the anthrax vaccine and collected short-term safety data from approximately 16,000 doses administered to almost 7000 individuals. While some recent anthrax vaccine safety studies have suggested that women experience more injection site reactions (ISRs), to our knowledge the IND safety data were not previously examined for a gender-specific difference. METHODS: We identified and analyzed a subset of the IND study data representing a total of 1749 persons who received 3592 doses from 1967 to 1972. Original data collection forms were located and information extracted, including: vaccine recipient's name, age at vaccination, gender, dose number, date of vaccination, lot number, grading of ISR, presence and type of systemic reactions. Overall and gender-specific rates for adverse reactions to anthrax vaccine were calculated and we performed a multivariable analysis. RESULTS: We found an ISR was associated with 28% of anthrax vaccine doses; however, 87% of these were considered mild. Systemic reactions were uncommon (<1%) and most (70%) accompanied an ISR. Our dose-specific analysis by gender found women had at least twice the risk of having a vaccine reaction compared to men. Our age-adjusted relative risk for ISR in women compared to men was 2.78 (95%CI: 2.29, 3.38). CONCLUSIONS: Our results for both overall and gender-specific reactogenicity are consistent with other anthrax safety studies. To date, possible implications of these gender differences observed for anthrax and other vaccines are unknown and deserve further study.