The Good Publication Practice (GPP) guideline provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceuti... These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented bio...

Objectives. To evaluate the clinical efficacy and tolerability of etoricoxib in the treatment of osteoarthritis (OA) of the knee and define the clinically active dose range for further clinical trials. Methods. This two‐part, randomized, double‐blind, placebo‐ and active comparator‐controlled trial was conducted in 617 adults with knee OA. In Part 1 (6 weeks), patients received placebo, etoricoxib 5, 10, 30, 60 or 90 mg q.d. In Part 2 (8 weeks), patients received etoricoxib 30, 60 or 90 mg q.d. or diclofenac 50 mg t.i.d., predetermined at Part 1 allocation. Efficacy and safety were evaluated. Primary efficacy end‐points were the Western Ontario and McMaster's University Osteoarthritis Index (WOMAC) Pain subscale, Patient Global Assessment of Response to Therapy, and Investigator Global Assessment of Disease Status. Results. At 6 weeks, etoricoxib 5, 10, 30, 60 and 90 mg each demonstrated clinical efficacy superior to placebo. Maximal efficacy was seen with 60 mg. In Part 2, etoricoxib 30, 60 and 90 mg were generally similar to diclofenac. Patients receiving etoricoxib 30, 60 or 90 mg in Parts I and II had sustained effects over 14 weeks. All treatments were well tolerated. Conclusions. Etoricoxib 60 mg once daily showed maximal efficacy in treating OA in this study. Etoricoxib 5–90 mg once daily was generally well tolerated in OA patients for up to 14 weeks.

Rofecoxib, a cyclooxygenase 2 inhibitor (sometimes known as a specific cyclooxygenase 2 inhibitor or Coxib), is used in osteoarthritis (OA). Published information indicates rofecoxib's improved gastrointestinal safety profile over nonselective nonsteroidal anti-inflammatory agents (NSAIDs). To evaluate the efficacy and safety of rofecoxib in treating OA in 2 studies. Two randomized, double-blind, parallel-group studies in patients with OA of the knee or hip were conducted using identical entry criteria and end points. A 6-week placebo-controlled trial in 736 patients compared 12.5 and 25 mg of rofecoxib once daily with 800 mg of ibuprofen 3 times daily, and a 1-year study compared 12.5 and 25 mg of rofecoxib once daily with 50 mg of diclofenac 3 times daily in 693 patients. Rofecoxib, at 12.5 and 25 mg, demonstrated efficacy clinically comparable with ibuprofen, assessed by 3 primary end points according to predefined comparability criteria. Both rofecoxib doses and ibuprofen provided significantly greater efficacy than placebo on all primary end points at 6 weeks. Both rofecoxib doses and diclofenac showed similar efficacy over 1 year. All treatments were well tolerated. Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year. Arch Fam Med. 2000;9:1124-1134

The meningococcal antigen typing system (MATS) sandwich enzyme-linked immunosorbent assay (ELISA) was designed to measure the immunologic cross-reactivity and quantity of antigens in target strains of a pathogen. It was first used to measure the factor H-binding protein (fHbp), neisserial adhesin A (NadA), and neisserial heparin-binding antigen (NHBA) content of serogroup B meningococcal (MenB) isolates relative to a reference strain, or “relative potency” (RP). With the PorA genotype, the RPs were then used to assess strain coverage by 4CMenB, a multicomponent MenB vaccine. In preliminary studies, MATS accurately predicted killing in the serum bactericidal assay using human complement, an accepted correlate of protection for meningococcal vaccines. A study across seven laboratories assessed the reproducibility of RPs for fHbp, NadA, and NHBA and established qualification parameters for new laboratories. RPs were determined in replicate for 17 MenB reference strains at laboratories A to G. The reproducibility of RPs among laboratories and against consensus values across laboratories was evaluated using a mixed-model analysis of variance. Interlaboratory agreement was very good; the Pearson correlation coefficients, coefficients of accuracy, and concordance correlation coefficients exceeded 99%. The summary measures of reproducibility, expressed as between-laboratory coefficients of variation, were 7.85% (fHbp), 16.51% (NadA), and 12.60% (NHBA). The overall within-laboratory measures of variation adjusted for strain and laboratory were 19.8% (fHbp), 28.8% (NHBA), and 38.3% (NadA). The MATS ELISA was successfully transferred to six laboratories, and a further laboratory was successfully qualified.

Meningococcal disease remains a global public health concern despite the wide availability of polysaccharide and polysaccharide-protein conjugate vaccines. The latter often afford a greater duration and scope of protection compared with the former. A novel quadrivalent meningococcal conjugate vaccine, Menveo(®) (MenACWY-CRM; Novartis Vacines, Bellaria-Rosia, Italy) has recently been licensed in Europe, the USA, Canada and other countries to protect adolescents and adults against disease caused by serogroups A, C, W-135 and Y. MenACWY-CRM has an immunogenicity and tolerability profile in adolescents and adults supported by an extensive clinical development program. MenACWY-CRM induced immune responses that were at least as good as those induced by Menactra(®) (MenACWY-D; Sanofi Pasteur [Swiftwater, PA, USA]), a quadrivalent meningococcal polysaccharide-protein conjugate vaccine) against serogroups A, C, W-135 and Y. Immune responses were also observed in a population of subjects 56-65 years of age. Published information also shows immunogenicity in infants, toddlers and children. Tolerability outcomes were similar for MenACWY-CRM, MenACWY-D and a plain polysaccharide quadrivalent vaccine against meningococcal serogroups A, C, W-135 and Y. Given its potential for protecting infants and persons over 55 years of age, MenACWY-CRM offers promise to fulfil an unmet global need for preventing invasive meningococcal disease in vulnerable populations for which no vaccine is available.