The Experts below are selected from a list of 89688 Experts worldwide ranked by ideXlab platform
Diego Guillen - One of the best experts on this subject based on the ideXlab platform.
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rationale and design of a community based double blind randomized clinical trial of an hpv 16 and 18 vaccine in guanacaste costa rica
Vaccine, 2008Co-Authors: Rolando Herrero, Allan Hildesheim, Ana Cecilia Rodriguez, Sholom Wacholder, Concepcion Bratti, Diane Solomon, Paula Gonzalez, Carolina Porras, Silvia Jimenez, Diego GuillenAbstract:We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A Complex Protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.
Rolando Herrero - One of the best experts on this subject based on the ideXlab platform.
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rationale and design of a community based double blind randomized clinical trial of an hpv 16 and 18 vaccine in guanacaste costa rica
Vaccine, 2008Co-Authors: Rolando Herrero, Allan Hildesheim, Ana Cecilia Rodriguez, Sholom Wacholder, Concepcion Bratti, Diane Solomon, Paula Gonzalez, Carolina Porras, Silvia Jimenez, Diego GuillenAbstract:We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A Complex Protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.
Kenneth A Getz - One of the best experts on this subject based on the ideXlab platform.
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cost drivers of a hospital acquired bacterial pneumonia and ventilator associated bacterial pneumonia phase 3 clinical trial
Clinical Infectious Diseases, 2018Co-Authors: Stella Stergiopoulos, Sara B Calvert, Carrie A Brown, Josephine Awatin, Pamela Tenaerts, Thomas L Holland, Joseph A Dimasi, Kenneth A GetzAbstract:Background:Studies indicate that the prevalence of multidrug-resistant infections, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their Complex Protocol designs and the difficulty in recruiting and retaining patients. Methods:With input from clinicians, representatives from industry, and the US Food and Drug Administration, we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs; (2) to identify opportunities to lower these costs; and (3) to compare (1) and (2) to endocrine and oncology clinical trials. Benchmark data were gathered from proprietary and commercial databases and used to create a model that calculates the fully loaded (direct and indirect) cost of typical phase 3 HABP/VABP endocrine and oncology clinical trials. Results:Results indicate that the cost per patient for a 200-site, 1000-patient phase 3 HABP/VABP study is $89600 per patient. The cost of screen failures and screen failure rates are the main cost drivers. Conclusions:Results indicate that biopharmaceutical companies and regulatory agencies should consider strategies to improve screening and recruitment to decrease HABP/VABP clinical trial costs.
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improving Protocol design feasibility to drive drug development economics and performance
International Journal of Environmental Research and Public Health, 2014Co-Authors: Kenneth A GetzAbstract:Protocol design Complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost of conducting less essential and unnecessary Protocol procedures and of implementing amendments to Protocol designs. Indirect costs including personnel time, work load and cycle time delays associated with Complex Protocol designs are also discussed. The author concludes with an overview of steps that research sponsors are taking to improve Protocol design feasibility.
Allan Hildesheim - One of the best experts on this subject based on the ideXlab platform.
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rationale and design of a community based double blind randomized clinical trial of an hpv 16 and 18 vaccine in guanacaste costa rica
Vaccine, 2008Co-Authors: Rolando Herrero, Allan Hildesheim, Ana Cecilia Rodriguez, Sholom Wacholder, Concepcion Bratti, Diane Solomon, Paula Gonzalez, Carolina Porras, Silvia Jimenez, Diego GuillenAbstract:We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A Complex Protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.
Diane Solomon - One of the best experts on this subject based on the ideXlab platform.
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rationale and design of a community based double blind randomized clinical trial of an hpv 16 and 18 vaccine in guanacaste costa rica
Vaccine, 2008Co-Authors: Rolando Herrero, Allan Hildesheim, Ana Cecilia Rodriguez, Sholom Wacholder, Concepcion Bratti, Diane Solomon, Paula Gonzalez, Carolina Porras, Silvia Jimenez, Diego GuillenAbstract:We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A Complex Protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.