Abstract:

This article will cover concepts of association and outcomes, introduce standard epidemiological concepts of incidence and prevalence, define and describe relative risk, absolute risk, attributable risk and the various methods for calculating those quantities in different observational research designs. Definitions of and methods for reducing bias are major components of this section.

Epidemiology is the study of disease in populations. It thus differs from the more conventional medical approaches to the study of disease that is normally concerned with the study of disease processes in affected individuals.Cohort, cross sectional, and case-control studies are collectively referred to as observational studies. Often these studies are the only practicable method of studying various problems, Cohort studies are used to study incidence, causes, and prognosis. Because they measure events in chronological order they can be used to distinguish between cause and effect. Cross sectional studies are used to determine prevalence. They are relatively quick and easy but do not permit distinction between cause and effect. Case controlled studies compare groups retrospectively. They seek to identify possible predictors of outcome and are useful for studying rare diseases or outcomes.

The crucial point of a clinical trial is the aim of investigating the difference of the patient groups caused only by the treatment procedures that are applied. If other kinds of differences exist (such as systematic differences) between the groups to be formed, then the outcomes are supposed to be biased. Forms of bias can corrupt a study at any phase, including patient selection (selection and membership bias), study performance (performance and information bias), patient follow-up (non responder and transfer bias), and outcome determination (detection, recall, acceptability, and interviewer bias).

The two common methods that are used to reduce the bias are randomization and blinding. The aim of randomization in clinical trials is the creation of groups that are comparable for any known or unknown, potentially confounding variables. Randomization, if done properly, ensures strengthening both the internal validity by minimizing selection bias and external validity by providing a correct basis for generalization. Simple randomization, weighted randomization, block randomization, stratified randomization, and minimization methods are discussed in this article.

Keywords: Epidemiology, simple randomization, block randomization, stratified randomization, minimization and blinding.

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Abstract:

This is an article review based on a research work on ‘Adverse reactions to iodinated contrast media, prevalence, risk factors and outcome – the results of a 3-year period’ by Panitan, et al., published in the Asian Pac J Allergy Immunology; April 31 2013: 299 – 306. http://apjai.digitaljournals.org. The review will comprise a brief summary of the article and a critical analysis of the structure. The article’s general content and scope will also be assessed for currency and relevance. The article’s authority on the issues discussed and credibility in view of current knowledge will also be evaluated.

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Abstract:

Streptococcus pneumoniae is Gram-positive alpha haemolytic bacteria that commonly found in the nosphrynax of elderly people and young children; it causes approximately 2 million deaths mostly children under age of 5 year and people over 60 years of age. Most important diseases caused by S. pneumoniae are including pneumonaie, meningitis and bacteraemia. The pathogens can be transmitted through contact. Streptococcuspneumoniae obtains its energy mainly carbohydrates through fermentation process. However, in some situations where there are limited sugars or in the presence of galactose the homolactic fermentation is shifted to mixed fermentation in which in addition to lactate, ethanol, formate and acetate are formed. In this study, the role of lactate (lactic acid) and formate (formic acid) in bacterial competition and cytotoxicy was investigated. We hypothesised that lactic acid and formic acid are able to contribute to the virulence of streptococcus pneumoniae. Bacteria were grown on either BHI or BAB. The killing assay was done by exposing various acids on S.pneumoniae as control then lactic acid producing bacteria and non-acid producing bacteria was tested with these acids. Growth assay experiment was done followed by cytotoxicity test using A549 epithelial cells incubated for 24h. The effect of lactic acid for killing assay was significant. Similar effect was seen when lactic acid was exposed to A549 cells. However, a hydrochloric acid was unable to inhibit the growth of bacteria. This study concludes that lactic acid produced by Streptococcus pneumoniae is a potential virulence factor and may contribute to Streptococcus invasive disease.

Keywords: Streptococcal, pneumonia, Gram-positive immunocompromised, microorganisms BAB, Lactate, fermentation

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Abstract:

Objective:

The main project is about finding perspective of Indian population (segregated into 3 categories: Patients, Healthy Volunteers, and Parents) on Clinical Research.

Design

A survey in the question-answer form was carried out including the Volunteers/Participants of Clinical research all over different regions of India. Questionnaires were filled with the help of investigators, physicians, social workers, freelancers, and research professionals, etc.

Methods

Clinical research is an important factor but it is only possible when Healthy Volunteers are participating in the clinical research. Physiological and anatomical conditions of a participant are taken in to consideration. Therefore diseases & conditions and their treatments also vary among each individual. This study has major focus on the awareness and perspective of Indian participants and their views towards clinical research. Also, participants are provided with proper treatment, confidentiality, compensation, proper treatment and knowledge as well as safety which always remain the top priority.

Results

There were 28 different parameters/data points based on which the data was collected from 1114volunteers/participants across the country. As the available data is dichotomous, a dynamic analysis was done using a percentile method.

Conclusion

In India, regulatory health authority such as the Central Drugs Standard Control Organization (CDSCO) – the office of the Drug Controller General (India), set the necessary guidelines & schedules for ethical conduction of clinical trials. This survey overall displays the analysis study all about the volunteers for clinical researches. It throws light on their understanding about ‘clinical research’, their beliefs, dis-beliefs about certain facts of clinical research. The whole survey was categorized into three types: Part of the population who agreed to a certain pattern of survey, one part which did not agree and the third one being unaware at all. It was observed that people who believed or thought that the facts involved were true or correct were at an appreciable percentage when compared to those who considered it as False. Whereas, the number of people who were un-aware couldn’t be ignored either.

Keywords: Clinical trials, Awareness, Volunteer/Participant Perspective, Safety, Confidentiality, Compensation, Harm /Benefit to the society, Participation, Financial gain, Collaboration.

References:

[1]. A.R., C. (n.d.). Clinical trials: present and future in India. Retrieved February 2015, from Pharmainfo.net: http://www.pharmainfo.net

[2]. Bhatt, A. (2006). Winds of Change - Evolution of clinical drug trials in India. Pharma Times(38:), pp. 19-20.

[3]. Bhatt, A. S. (2004, Feb 26). Indian clinical research odyssey. Pharma Biz(Chronicle specials). Retrieved January 2015, from http://saffron.pharmabiz.com/article/detnews.asp?articleid=20742&sectionid=50

[4]. Bindra, S. K. (2010). Survey on perceptions of indian investigators on research ethics. Perceptives in Clinical Research, 1:, 94-7.

[5]. Das, N. (n.d.). Outsourcing clinical trials to India. Chillibreeze Solutions Pvt. Ltd. Retrieved February 2015, from http://www.chillibreeze.com

[6]. De, M. (2005). India, ideal destination for clinical trials. CurrSci, 89:597.

[7]. Fenn, C. W. (2001). The contemporary situation for the conduct of clinical trials in Asia. Int J Pharm Med(15:), 169-73.

[8]. Jayasheel, B. (2010). Issues regarding delay in regulatory approvals carrying out clinical trials in India. Regulatory Affairs Journal Pharma, 1-4.

[9]. Moin, D. (2013). Clinical trials and safety reporting under Schedule Y. Retrieved February 2015, from Pharmabiz: http://www.pharmabiz.com.

[10]. N., V. (2006, June 1). Conducting clinical trials in Asia. Retrieved February 2015, from http://www.actmagazine.com

[11]. Parikh RM, G. M. (2011;). Trend of clinical drug trials in type 2 DM over last decade. Percept Clin Res, 2:, 64-6.

[12]. Research and Markets. (2006). India: pharmaceutical and biotechnology opportunities. India: Pharmalicensing Ltd. Retrieved January 2015, from http://www.researchandmarkets.com

Works Cited

[1]. A.R., C. (n.d.). Clinical trials: present and future in India. Retrieved February 2015, from Pharmainfo.net: http://www.pharmainfo.net

[2]. Bhatt, A. (2006). Winds of Change - Evolution of clinical drug trials in India. Pharma Times(38:), pp. 19-20.

[3]. Bhatt, A. S. (2004, Feb 26). Indian clinical research odyssey. Pharma Biz(Chronicle specials). Retrieved January 2015, from http://saffron.pharmabiz.com/article/detnews.asp?articleid=20742&sectionid=50

[4]. Bindra, S. K. (2010). Survey on perceptions of indian investigators on research ethics. Perceptives in Clinical Research, 1:, 94-7.

[5]. Das, N. (n.d.). Outsourcing clinical trials to India. Chillibreeze Solutions Pvt. Ltd. Retrieved February 2015, from http://www.chillibreeze.com

[6]. De, M. (2005). India, ideal destination for clinical trials. CurrSci, 89:597.

[7]. Fenn, C. W. (2001). The contemporary situation for the conduct of clinical trials in Asia. Int J Pharm Med(15:), 169-73.

[8]. Jayasheel, B. (2010). Issues regarding delay in regulatory approvals carrying out clinical trials in India. Regulatory Affairs Journal Pharma, 1-4.

[9]. Moin, D. (2013). Clinical trials and safety reporting under Schedule Y. Retrieved February 2015, from Pharmabiz: http://www.pharmabiz.com.

[10]. N., V. (2006, June 1). Conducting clinical trials in Asia. Retrieved February 2015, from http://www.actmagazine.com

[11]. Parikh RM, G. M. (2011;). Trend of clinical drug trials in type 2 DM over last decade. Percept Clin Res, 2:, 64-6.

[12]. Research and Markets. (2006). India: pharmaceutical and biotechnology opportunities. India: Pharmalicensing Ltd. Retrieved January 2015, from http://www.researchandmarkets.com

Abstract:

Nigeria has one of the most varied ecosystems and expanse bio-resources and biodiversity. Its biodiversity is an important source of food, medicines and natural products. The natural products form the basis for varied traditional medicine systems that have been in existence and sustained the people for thousands of years. The traditional medicine practices of Nigeria are as diverse as the people of Nigeria which is made up of more than 300 ethnic communities.

The traditional medicine practice systems of Nigeria is bedevilled with the double throng challenges of inadequate documentation and lack of clinical evidence bases for use since their uses by many cultures have not been properly and extensively documented, and various practice centres fall short of meeting the basic standard requirement for clinical practice. It is right therefore to point out that the wealth of Nigeria’s traditional medicine knowledge and its associated rich practices lack structured evidence based systems to support clinical claim for integration into the mainstream health system. In this regard, only a few if any such as the PAX herbal clinic is a model for emulation.

This shortcoming is quite critical if we consider that Nigerian Traditional Medicine systems and medicines play vital roles in the healthcare delivery of the people especially at the level of primary healthcare. Also, that it is a vital source of natural product leads for the development of the most effective drugs for the treatment/management of a variety of human ailments. The import of this shortcoming becomes glaring if we reflect on the report pointing out that the global trend for incorporation of traditional medicine into health systems was on the increase globally. And also that such use is in the light of chronic ailments which conventional medicine is incapable of treating.

This paper will attempt to discuss the critical challenge of integrative medicine –herbal medicine at the crossroad of clinical practice in Nigeria- in a quest for a mainstream strategy for acquiring evidence bases and translation of Nigerian Traditional medicines to clinical care.

Key words: Herbal Medicine, Traditional Nigerian Medicine, Translational Medicine, Clinical Research

References:

[1]. Ademuwagum, Z. S., (1973). Problems and Prospects of Integrating Traditional Health Care System and Methods With Modern Medical Therapy -The Igbo-Ora Experience in Proceedings of the International Symposium on Traditional Medical Therapy: A Critical Appraisal; December 10 – 16, 1973 National Science and Technology Development Agency, B, Stranchan Street, P.M.B. 12695, Lagos, Nigeria. Page 35-38.

[2]. Ameh S. J., Obodozie, O. O., Chindob, B. A., Babalola, P. C., and Gamaniel K. S., (2012). Herbal Clinical 'I'rials-Hlstorlcal Development and Application in the 21st Century. Pharmacologia 3(5): 121-131, DOI: 10.5567/pharmacologia.2012.121.13l 2012. Science Reuters, UK

[3]. Brownson, R. C., Kreuter, M. W., Arrington, B. A., True, W. R., (2006). Translating Scientific Discoveries Into Public Health Action: How Can Schools Of Public Health Move Us Forward? Public Health Reports Volume 121, 97-103

[4]. Bubela T., Boon H. and Caulfield T., (2008). Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals BMC Medicine, 6:35 doi:10.1186/1741-7015-6-35 available from: http://www.biomedcentral.com/1741-7015/6/35

[5]. Emmanuel, L. A., (1973) Nigeria traditional medicine –A conceptual Analysis in Proceedings of the International Symposium on Traditional Medical Therapy: A Critical Appraisal; December 10 – 16, 1973 National Science and Technology Development Agency, B, Stranchan Street, P.M.B. 12695, Lagos, Nigeria. Page 52-57.

[6]. Ernst, E., Cohen, M. H., Stone, J., (2004). Ethical problems arising in evidence based complementary and alternative medicine. J Med Ethics, 30, 156–159. doi: 10.1136/jme.2003.007021

[7]. Frenkel, M. A., and Borkan J. M., (2003). An approach for integrating complemetary–alternative medicine into primary care. Family Practice, 20(3), 324–332. Doi: 10.1093/fampra/cmg315, available online at www.fampra.oupjournals.org

[8]. Graz, B., Elisabetsky, E., and Falquet, J., (2007). Beyond the myth of expensive clinical study:Assessment of traditional medicines Journal of Ethnopharmacology 113 382–386

[9]. Harrison, I. E., (1973). Traditional Healers: a Neglected Source of Health Manpower in Proceedings of the International Symposium on Traditional Medical Therapy: A Critical Appraisal; December 10 – 16, 1973 National Science and Technology Development Agency, B, Stranchan Street, P.M.B. 12695, Lagos, Nigeria. Page 27 – 31.

[10]. Jia, W., Kohlmeier, M., Lu, A., Zeng, R., (2013). Translational Research in Complementary and Alternative Medicine. Evidence-Based Complementary and Alternative Medicine. http://dx.doi.org/10.1155/2013/296817

[11]. Orgah A.E (2008). Enhancing domestic drug production capacity in developing countries: approaches, prospects and Constraints. In –Advances In Natural Products; Importance in Health and Economy 2008. Page 181-191; Centre for Science and Technology of the Non-Alligned and other developing countries (NAM S&T Centre). Daya Publishing House, Delhi 110035

[12]. Qian, M., Wu, D., Wang, E., Marincola, F. M., Wang, W., Rhodes, W., Liebman, M., Bai, C. Lam, C.-W., Marko-Varga, G. Fehniger, T. E., Andersson, R. and Wang, X., (2012). Development and promotion in translational medicine: perspectives from 2012 sino-american symposium on clinical and translational medicine. Clinical and Translational Medicine 1:25 http://www.clintransmed.com/content/1/1/25

[13]. Shergis, J. L., Parker, S., Coyle, M. E., Zhang, A. L., and Xue C. C., (2013), ‘Key considerations for conducting Chinese medicine clinical trials in hospitals’. Chinese Medicine vol. 8, no. 3 http://www.cmjournal.org/content/8/1/3

[14]. Singh, H. P., Sharma, S., Chauhan, S. B., and Kaur, I., (2014). Clinical Trials of Traditional Herbal Medicines in India: Current Status and Challenges; International Journal of Pharmacognosy, 1(7): 415-421 http://dx.doi.org/10.13040/IJPSR.0975-8232.IJP.1(7).415-421

[15]. Sun, X. G., Lin, D., Wu, W., Lv,. Z.(2011). Translational Chinese Medicine: A Way for Development of Traditional Chinese Medicine. Chinese Medicine, 2, 186-190 doi:10.4236/cm.2011.24029

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[17]. Wang, X., Wang, E., Marincola, F. M., (2011). Translational Medicine is developing in China: A new venue for collaboration. Journal of Translational Medicine, 9(3).

[18]. WHO (Ed.). (2013). WHO traditional medicine strategy, 2014-2023. Geneva: World Health Organization (WHO).

[19]. WHO/EDM/TRM/2000.1 (2000). General Guidelines for Methodologies On Research and Evaluation of Traditional Medicine. WHO, Geneva.

[20]. Willcox, M. L., Graz, B., Falquet, J., Diakite, C., Giani, S., Diallo, D., (2011). A “reverse pharmacology” approach for developing an anti-malarial phytomedicine; Malaria Journal, 10(Suppl 1):S8 http://www.malariajournal.com/content/10/S1/S8

[21]. Xu Q., Bauer R., Hendry B. M., Fan T-P., Zhao Z., Duez P., Simmonds M. S. J., Witt C. M., Lu A., Robinson N., Guo D-a. and Hylands P. J. (2013). The quest for modernisation of traditional Chinese medicine; BMC Complementary and Alternative Medicine, 13:132 http://www.biomedcentral.com/1472-6882/13/132

[22]. Zhang J M. (2012). Translational medicine in China. Sci China Life Sci, 55: 834–836, doi: 10.1007/s11427-012-4373-0

[23]. Zhang, B., Zhang, J., Hu, J., (2012). Thinking about translational medicine and traditional Chinese medicine. Journal of Translational Medicine, 10(Suppl 2):A33 http://www.translational-medicine.com/content/10/S1/A33

Abstract:

There has been an astronomical rise in the cost of developing drugs in the last four decades. This has had a resultant effect on public health and Nigeria is particularly negatively affected. As the world spends more money on drugs’ R&D, the volume of innovative synthetic drugs dwindles. This trend points to the necessity for a paradigm shift in drug development strategy.

Although herbal medicines offer a wide diversity of medicinal properties and have proven to be a boom for therapies, its clinical evidence mapping is largely lacking and thus cannot be integrated into Nigerian public health structures. Also, there is a high incidence ranking of malaria in Nigeria, and clinical evidence mapping of herbal anti-malarias might be the innovation to improve malaria control and elimination programs.

Few or no studies have illustrated methods to engage herbal medicine clinics in Africa and perhaps none in Nigeria on ways to describe and evaluate clinical use of herbal medicines as anti-malarial in patients. Observational clinical studies could be carried out to estimate the efficacy and toxicities of herbal anti-malarias in clinical protocols and thus document any adverse effects. This should provide the needed opportunity to measure patient outcome in malaria patients exposed to the herbal drug in a clinical setting. This paper discuses the challenges to drug development in weak and fledgling economies, the dearth of clinical research on herbal anti-malarial therapies and the prospects of herbal clinical research to malaria control and public health in Nigeria.

Key words: Herbal anti-malaria, Malaria, Herbal medicines’ clinical evidence research, Drug development and Public health

References:

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Abstract:

South Africa has a significant burden of both communicable and non-communicable diseases are on the rise. Clinical research has been portrayed by Ministry of health in South Africa to improve the health condition of the nation reducing the disease burden. However, the research has not kicked in as planned by the research output and awareness of public regarding the clinical research. Hence, the present study was conducted to assess the hurdles faced by the health care personnel in implementing research in their institutions in South Africa .

Keywords: Clinical Research, South African hospitals. Clinician’s capacity, naïve patients.

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Abstract:

Aims: Guidelines have been designed to prepare best quality systematic review and meta-analysis reports to provide rational concise predictions about elaborate and complex of clinical trial data. Latest update in these guidelines is given by PRISMA-P 2015, which we wish to analyze for predicting its acceptability over the old PRISMA 2009.

Methods: We studied 287 articles from 143 Journals listed in Pubmed and sorted them on the basis of inclusion and exclusion criteria to predict the number of articles published in 2015 which followed the latest PRISMA-P checklist.

Results: Out of 287 articles 208 relevant articles were selected from which 182 (87.5%) followed the old PRISMA 2009 statement, 4(1.9%) did not follow PRISMA guideline, while 14 (6.7%) partially followed the same. Only 8 (3.8%) of the articles published in 2015 after February, followed the updated PRISMA-P statement.

Conclusion: Results of the present study predicts probable apprehension of authors towards PRISMA-P 2015 statement.

Keywords: Meta-analysis, Systematic reviews, PRISMA, PRISMA-P.

References:

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[3.] Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.

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[5.] Tsivgoulis G, Katsanos AH, Grigoriadis N, Hadjigeorgiou GM, Heliopoulos I, Kilidireas C, et al. The Effect of Disease Modifying Therapies on Brain Atrophy in Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review and Meta-Analysis. PLoS ONE. [doi:10.1371/journal.pone.0116511]. 2015;10(3):e0116511.

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[8.] Parra-Medina R, Molano-Gonzalez N, Rojas-Villarraga A, Agmon-Levin N, Arango M-T, Shoenfeld Y, et al. Prevalence of Celiac Disease in Latin America: A Systematic Review and Meta-Regression. PLoS ONE. [doi:10.1371/journal.pone.0124040]. 2015;10(5):e0124040.

[9.] Jin Y, Wang H, Ma X, Liang X, Liu X, Wang Y. Clinicopathological Characteristics of Gynecological Cancer Associated with Hypoxia-Inducible Factor 1α Expression: A Meta-Analysis Including 6,612 Subjects. PLoS ONE. [doi:10.1371/journal.pone.0127229]. 2015;10(5):e0127229.

[10.] Sobers-Grannum N, Murphy MM, Nielsen A, Guell C, Samuels TA, Bishop L, et al. Female Gender Is a Social Determinant of Diabetes in the Caribbean: A Systematic Review and Meta-Analysis. PLoS ONE. [doi:10.1371/journal.pone.0126799]. 2015;10(5):e0126799.

[11.] Bell JM, Shields MD, Agus A, Dunlop K, Bourke T, Kee F, et al. Clinical and Cost-Effectiveness of Procalcitonin Test for Prodromal Meningococcal Disease–A Meta-Analysis. PLoS ONE. [doi:10.1371/journal.pone.0128993]. 2015;10(6):e0128993.

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Abstract:

Johnson J., Gupta N.V., “Recent Advances in Quality Management of Clinical Trials” International Journal of Pharmacy and Pharmaceutical Science 2013, vol 5: issue 3, 34-38. Viewed on March 24, 2015, www.ijppsjournal.com/vol5issue3/6932.pdf

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