Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

BACKGROUND: This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase-IV clinical trials. // METHODS: Two reviewers independently assessed CTRs of International Committee of Medical Journal Editors (ICJME) and of WHO platforms. Each CTR was checked by two reviewers on availability of fields on brand name; manufacturer’s name; approval status; approving authority; compliance with Good Manufacturing Practices; and quality testing. In case of discrepancy, consensus was sought between the two reviewers. // RESULTS: Of 19 identified CTRs, 8 and 6 belonged to WHO and ICMJE, respectively, while 5 were equally part of both platforms. All CTRs had an “intervention” field where data on IMPs and IMP comparators are captured. The Canadian CTR used “drug name” rather than “intervention”. The EU, Peruvian, and UK CTRs had fields for “brand name”. But only the EU CTR had fields for “manufacturer’s name”, “approval status”, and “approving authority”. None of the CTRs had fields on “compliance with Good Manufacturing Practices” or “quality testing”. // CONCLUSION: This study demonstrates that none of the CTRs of ICMJE and ICTRP platforms has adequate fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the lengthy requirements in WHO and ICMJE guidelines. Considering the relation between IMP quality and safety of clinical trial participants, the gap of quality assurance fields should be bridged at CTRs concurrently to adjustments of WHO and ICMJE guidelines on CTRs. Specifically, IMP quality testing addressing issues on IMP appearance, impurities, microbial contamination, and dosing should be conducted and reported before, during, and after clinical trial conduct. Until adoption of these measures, the EU CTR should be preferred for registration of phase-IV clinical trials conducted in countries lacking stringent regulatory capacities

Multicentre study of the treatment of primary liver cancer in Africa with two anthracycline drugs

A study of the treatment of primary liver cancer in tropical Africa.Hepatocellular carcinoma (HCC) is among the twelve commonest cancers affecting mankind. In tropical Africa HCC is the most common malignant tumor, particularly among men. In Kyadondo County of Uganda the incidence rate is 5,1 cases per 100 000 men. In Nigeria the figure quoted for both sexes is 5,9 per 100 000 population. In Zimbabwe the incidence among the Black population is 20,8 per 100 000, while in Mozambique the figure is 103,8 per 100 000 males. These figures are in contradiction to what is observed in Europe and North America. In England HCC occurs in 2,5 per 100 000, while in North America it is seen in 1,8 per 100 000

Brittle asthma a report of 2 cases

Brittle asthma, even though it is thought to be a rare form of Asthma, may form the bulk of our difficult to treat asthma and frequently unresponsive exacerbation. Brittle Asthma. Brittle asthma is a rare form of severe asthma characterized by a wide variation of Peak Expiratory Flow (PEF)1, in spite of high doses of inhaled steroids and bronchodilator therapy. Brittle asthmatic patients have very serious and often, life threatening, attacks. There are two forms of brittle asthma.Case PresentationWe present the cases of a 45yr old Nurse anesthetics who was diagnosed >5yrs ago and a 56yr old unemployed who was diagnosed >15yrs ago. Both have been stable for years on add on maintenance therapy with high doses of inhaled corticosteroid and β2 agonist as oral salbutamol and an inhaler therapy during exacerbation. Recently, both patients noticed worsening of symptoms despite high dose therapy, They have been in and out of hospital recently for uncontrolled asthma. They later had to be admitted in ICU because of respiratory insufficiency. These two lapsed into brittle asthma with recurrent bronchospasm, due to repeated  to anesthetic agents and environmental exposure at home respectively.Keywords: Brittle Asthma, Peak Expiratory Flow (PEF), Respiratory Insufficiency, environmental exposur

Rapid Diagnostic Algorithms as a Screening Tool for Tuberculosis: An Assessor Blinded Cross-Sectional Study

Background: A major obstacle to effectively treat and control tuberculosis is the absence of an accurate, rapid, and low-cost diagnostic tool. A new approach for the screening of patients for tuberculosis is the use of rapid diagnostic classification algorithms. Methods: We tested a previously published diagnostic algorithm based on four biomarkers as a screening tool for tuberculosis in a Central European patient population using an assessor-blinded cross-sectional study design. In addition, we developed an improved diagnostic classification algorithm based on a study population at a tertiary hospital in Vienna, Austria, by supervised computational statistics. Results: The diagnostic accuracy of the previously published diagnostic algorithm for our patient population consisting of 206 patients was 54% (CI: 47%–61%). An improved model was constructed using inflammation parameters and clinical information. A diagnostic accuracy of 86% (CI: 80%–90%) was demonstrated by 10-fold cross validation. An alternative model relying solely on clinical parameters exhibited a diagnostic accuracy of 85% (CI: 79%–89%). Conclusion: Here we show that a rapid diagnostic algorithm based on clinical parameters is only slightly improved by inclusion of inflammation markers in our cohort. Our results also emphasize the need for validation of new diagnostic algorithms in different settings and patient populations

The influence of cobalt/vitamin B 12

International audienc

Factors associated with occupational injuries at a bevarage manufacturing company in Harare, Zimbabwe - 2008

No Abstract