Why are emerging countries popular for clinical research?

BACKGROUND: The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may have implications for the local populations and their endemic diseases. OBJECTIVES: To identify potential reasons why emerging countries have become attractive places for international sponsors to conduct their clinical trials. METHODS: Using ClinicalTrials.gov, the Pan African Clinical Trials Registry, the National Health Research Database and the Nigeria Clinical Trials Registry, trend data on clinical research development were determined for two emerging African markets, Nigeria and South Africa (SA), from 2010 to 2018. Also, health data on the two countries from the fact sheets of health statistics of the World Health Organization were compared, as well as regulatory and ethical conditions. Available data were analysed using descriptive statistics and trend analysis. RESULTS: The impact of globalisation is evident from the upward trend in clinical trials in SA before 2010, and the clear downward trend thereafter. One reason for this change could be the alignment of SA's regulatory and ethical frameworks with the Western world. In contrast, the upward trend is only just beginning in Nigeria, with the introduction of ethical/regulatory frameworks, and supportive institutions making the business of clinical research more attractive on an international level. Although the number of international and local sponsors increased in Nigeria from 2010 to 2018, only the latter increased in SA, with the former decreasing over the same period. Overall, there is a mismatch between country-specific diseases and the drugs being tested, to the extent that leprosy, which is endemic in Nigeria, and tuberculosis in SA were not in the list of top 10 study areas in either country. CONCLUSIONS: The globalisation trend is evident in the clinical trials business, but cannot be generalised to all emerging countries. Timing and intensity vary from country to country relative to factors that advance the existing profit-orientated business models of the sponsors. Furthermore, various diseases have been localised, which entails a diversely increasing need for research.

Effects of physical exercises on inflammatory biomarkers and cardiopulmonary function in patients living with HIV: a systematic review with meta-analysis.

BACKGROUND: Pro-inflammatory cytokines expressed in human immune deficiency virus (HIV) infection, may induce oxidative stress likely to compromise the patency of the airways or damage the lung tissues/cardiac function. However, physical (aerobic and/or resistance) exercise-induced release of heat shock protein, immune function alteration or reduced tissue hypoxia, have been highlighted as possible mechanisms by which increasing physical activity may reduce plasma pro-inflammatory cytokines in uninfected individuals and should be appraised in the literature for evidence of similar benefits in people living with HIV (PLWH). Therefore, we evaluated the effects of physical exercises on 1) inflammatory biomarkers and 2) cardiopulmonary function (VO2 Max) in PLWH. METHOD: A systematic review was conducted using the Cochrane Collaboration protocol. Searching databases, up to January 2018. Only randomized control trials investigating the effects of either aerobic or resistance or a combination of both exercise types with a control/other intervention(s) for a period of at least 4 weeks among adults living with HIV, were included. Two independent reviewers determined the eligibility of the studies. Data were extracted and risk of bias (ROB) was assessed with the Cochrane Collaboration ROB tool. Meta-analyses were conducted with random effect models using the Review Manager (RevMan) computer software. RESULT: Twenty-three studies met inclusion criteria (n = 1073 participants at study completion) comprising male and female with age range 18-65 years. Three meta-analyses across three sub-groups comparisons were performed. The result showed no significant change in biomarkers of inflammation (IL-6 and IL-1ß) unlike a significant (Z = 3.80, p < 0.0001) improvement in VO2 Max. Overall, the GRADE evidence for this review was of moderate quality. CONCLUSION: There was evidence that engaging in either aerobic or resistance exercise, or a combination of both exercises, two to five times per week can lead to a significant improvement in cardiopulmonary function but not biomarkers of inflammation (IL-6 and IL-1ß). However, this should not be interpreted as "No evidence of effect" because the individual trial studies did not attain sufficient power to detect treatment effects. The moderate grade evidence for this review suggests that further research may likely have an important impact on our confidence in the estimate of effects and may change the estimate.

Walking balance is mediated by muscle strength and bone mineral density in postmenopausal women: an observational study.

BACKGROUND: Depletion of ovarian hormone in postmenopausal women has been associated with changes in the locomotor apparatus that may compromise walking function including muscle atrophy/weakness, weight gain, and bone demineralization. Therefore, handgrip strength (HGS), bone mineral density (BMD) and body composition [percentage body fat mass (%BFM), fat mass (FM), Fat-free mass (FFM) and body mass index (BMI)], may significantly vary and predict WB in postmenopausal women. Consequently, the study sought to 1. Explore body composition, BMD and muscle strength differences between premenopausal and postmenopausal women and 2. Explore how these variables [I.e., body composition, BMD and muscle strength] relate to WB in postmenopausal women. METHOD: Fifty-one pre-menopausal (35.74 + 1.52) and 50 postmenopausal (53.32 + 2.28) women were selected by convenience sampling and studied. Six explanatory variables (HGS, BMD, %BFM, FFM, BMI and FM) were explored to predict WB in postmenopausal women: Data collected were analyzed using multiple linear regression, ANCOVA, independent t-test and Pearson correlation coefficient at p < 0.05. RESULT: Postmenopausal women had higher BMI(t = + 1.72; p = 0.04), %BFM(t = + 2.77; p = .003), FM(t = + 1.77; p = 0.04) and lower HGS(t = - 3.05; p = 0.001),compared to the premenopausal women. The predicted main effect of age on HGS was not significant, F(1, 197) = 0.03, p = 0.06, likewise the interaction between age and %BFM, F(1, 197) = 0.02, p = 0.89; unlike the predicted main effect of %BFM, F(1, 197) = 10.34, p = .002, on HGS. HGS was the highest predictor of WB (t = 2.203; ß=0.3046) in postmenopausal women and combined with T-score right big toe (Tscorert) to produce R2 = 0.11;F (2, 47)=4.11;p = 0.02 as the best fit for the predictive model. The variance (R2) change was significant from HGS model (R2 = 0.09;p = 0.03) to HGS + Tscorert model (R2 = 0.11;p = 0.02). The regression model equation was therefore given as: WB =5.4805 + 0.1578(HGS) + (- 1.3532) Tscorert. CONCLUSION: There are differences in body composition suggesting re-compartmentalization of the body, which may adversely impact the (HGS) muscle strength in postmenopausal women. Muscle strength and BMD are associated with WB, although, only contribute to a marginal amount of the variance for WB. Therefore, other factors in addition to musculoskeletal health are necessary to mitigate fall risk in postmenopausal women.