Abstract:

This paper examined the ethics of Clinical Research and the protection of potential and enrolled human subjects. Clinical research is a lengthy and costly process. Subject recruitment and retention are an essential step to help lowering the cost and the length of clinical trials. Good quality research is crucial for determining the clinical and cost effectiveness of health care systems, at the same time recruitment of sufficient participants is a cornerstone for good quality research that tests hypotheses with confidence and minimizes bias. In this paper, I had the opportunity to highlight some ethical concerns and considerations that are related to recruiting human subjects in clinical research. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. This report serves as guidance for biomedical and behavioural researchers to find a summary of the basic ethical principles to protect human subjects basically: beneficence, justice, and respect for individuals.

The existing literature on the subject was reviewed all along to contextualize the study. I have used observation during the field trips and hands on knowledge of recruiting human subjects carried in my job. The process of informed consent is crucial in achieving these principles. In order to protect human subjects, the informed consent process involves the verbal discussion with the possible subject along with the paper document. Finding revealed that by placing some people at risk of harm for the good of others; clinical research has the potential to exploit patient volunteers. Undue inducement could be eliminated by careful assessment of risks, paying attention to eligibility criteria, collecting an informed and voluntary consent of research subjects. We should continually strive to bring in interactive learning opportunities for clinical researchers, ethics committee members, scientists, biomedical researchers and all other personnel involved in clinical development and translational research.

Keywords: Clinical Research, Good Clinical Practices, Ethics, Informed Consent, Potential Subjects Protection.

References:

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[8].Smith-Tyler J. Informed consent, confidentiality, and subject rights in clinical trials. Proceedings of the American Thoracic Society. 2007;4(2):189-93; discussion 93.

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[12]. Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomedical imaging and intervention journal. 2008;4(1): e5.

[13]. Wendler, David, "The Ethics of Clinical Research", The Stanford Encyclopedia of Philosophy (Spring 2009 Edition), Edward N. Zalta (ed.), URL https://plato.stanford.edu/archives/spr2009/entries/clinical-research.

Abstract:

A mutual Dilemma for site management organizations continues to be finding experienced clinical research coordinators. The success of clinical trials depends profoundly on clinical research coordinators as they play a key role in the executions of trial procedures. Therefore, the demand for experienced and qualified clinical research coordinators is extremely high. This article will describe the duties of clinical research coordinators, discuss how to stimulate their performance, and explore the training impact on CRCs.

Keywords: Clinical Trial; Clinical Research Coordinator; Research Nurse; Study Coordinator; Duties; Challenges; Performance; Training Impact.

References:

[1].Silver-Kessler, R., (2019). Research Coordinator Support: A Solution to Prevent Costly Data Delays- Remote EMR Access & Clinical Research Data Entry. www.imarcresearch.com/blog.

[2].National Academy of Sciences. (2010). Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Bookshelf ID: NBK50888.

[3].Shields, A.M., & Larue E.M. (2010). Transitioning from clinician to clinical research coordinator. PMID: 20647899 DOI: 10.1097/01.NURSE.0000387067.37626.d1.

[4].Gwede, C.K., (2016). Oncology Nursing Forum, November 2005. 32(6):1123-30.

[5].Butryn, T., Cornejo, K., Wojda, T.R., Papadimos, T.J., Gerlach, A.T., Deb, L., Sethi, A., Kramer6, C., Stawicki, S.P., (2016). Keys to success in clinical trials: A practical review. V.2, I.2, P.203-216.

[6].Eastabrook, J.M., McCrorie, D., Baker, S.P., Cannata, R., (2016). Enhanced Site Training, Resources, and Communication. Applied Clinical Trials Mar, I. 02, 2016.

[7].Willis, C., Bratcher, K., Kenworthy-Heinige, T., McBurney, C., Asghar, A., Beck, D., & Condon, D.L., (2018). The Anatomy of a Great Clinical Research Coordinator. Clinical Researcher- August 2018 (Volume 32, Issue 7).

Abstract:

Background: MDR-TB (Multidrug-resistant tuberculosis) reportedly proves to be the greatest public health issue on a global scale. The mutation tendency of Mycobacterium tuberculosis substantially elevates its resistance against the recommended pharmacotherapeutic interventions. Limited information on the MDR-TB diagnostic approaches and treatment options is primarily responsible for its extensive progression across resource-limited regions. The frequently reported adverse effects of the standard therapies barricade their long-term use by the MDR-TB patients.

Aim: The presented narrative review attempts to consolidate and strengthen the clinical evidence for improving the MDR-TB diagnosis and treatment decisions in health care settings.

Methods: The author performed an evidence-based analysis of the causative factors, pathophysiology, diagnostic techniques, and treatment options/challenges for MDR-TB through the systematic exploration of databases including Google Scholar, PubMed/Medline, and Cochrane Library. The utilization of these databases was effectively undertaken to explore the peer-reviewed MDR-TB-related articles based on meta-analysis, systematic review, retrospective study, randomized controlled trial, and narrative literature reviews.

Findings: The study findings revealed MDR-TB epidemiology, etiology, diagnostic approaches, preventive measures, pathogenesis, treatment adversities, and therapeutic potential in the context of controlling the prevalence of drug-resistant tuberculosis and related comorbidities.

Conclusion: The study findings advocate the need for improving the overall MDR-TB investigation and treatment process to control the elevated prevalence of MDR-TB among the suspected patients. The study outcomes advocate the requirement of multidisciplinary coordination between clinicians and researchers to effectively improve the medical decision-making quality for enhancing the therapeutic outcomes of MDR-TB patients.

Keywords: MDR-TB, Drug-resistant, tuberculosis, diagnosis, pathophysiology, treatment.

References:

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Abstract:

Clinical research and innovation continue to play an important role in the advancement of evidence based clinical practice regardless of its complex multi-step processes and accordingly related challenges.

Despite the adaption of technology and quality systems, site management organizations (SMOs) still face significant operational challenges to execute the studies effectively. SMOs administering various clinical trials in multiple clinical sites and operate with a vast number of clinical trial staff. Therefore, the need for effective management strategies, well trained multi-skilled staff, teamwork, and collaboration of all sites are very crucial. This review article lists most of the SMOs operational challenges as well as potential innovative solutions needed to enhance their management process.

Keywords: Clinical Trials; Multi-Sites Trial Management; Inter-institutional Collaboration

References:

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Abstract:

A cross sectional study was carried out to assess mean corpuscular volume (MCV) as a diagnostic marker of diabetic nephropathy in 122 type 2 diabetes mellitus patients and 61 non-diabetic participants at Kabwe Mine Hospital (KMH) in Zambia. A Structured questionnaire was used to capture age, sex, history of blood transfusion and cancer status of the participants. Urea, creatinine and urine albumin concentrations were measured and MCV determined. Renal profile tests (creatinine, urea and urine albumin) were used as a proxy marker for diabetic nephropathy in the patients. Patients with high renal profile tests (urea > 8.5 mmol/l, creatinine > 120µmol/l, urine albumin > 30mg/l) were considered to have diabetic nephropathy. The results revealed that creatinine concentration in the patients (750+4.0 µmol/l) was significantly higher (P=0.003) than in the control group (250+2.1 µmol/l). Similarly, the urea concentration in the patients (4.2+2.4 mmol/l) was significantly higher (P=0.002) than in the control group. However, the urine albumin concentration was similar (P=0.168) in the two groups. With regard to MCV, it was found to be higher (P=0.001) in the patients (150+7.0 fl) than in the control group (85+7.0 fl). MCV was found to have sensitivity of 93%, specificity of 96%, PPV 97%, NPV 91% and efficiency of 94% which were significant parameters to warrant the inclusion of MCV as one of the diagnostic markers of diabetic nephropathy. It is concluded that MCV is a reliable and suitable biomarker for detecting diabetic nephropathy in type 2 diabetes mellitus patients.

Keywords: diabetic nephropathy, type 2 diabetes mellitus, renal profile, mean corpuscular volume.

References:

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Abstract:

MDR-TB (Multidrug-Resistant Tuberculosis) reportedly proves to be the greatest health care burden responsible for a substantial deterioration of health-related quality of life of underprivileged people across the globe. MDR-TB. The late diagnosis of MDR-TB, absence of standardized therapy, and treatment delays are some of the significant factors that substantially elevate comorbidity and mortality risk of the affected patients. HIV positive MDR-TB patients experience a drastic reduction in their life expectancy and wellness outcomes. The WHO guidelines recommend various treatment regimens for the systematic treatment of MDR-TB. Category-4 therapy proves to be the standard treatment option for MDR-TB patients. However, the clinicians still require closely monitoring the clinical history of their MDR-TB patients/suspects in the context of including the most appropriate drugs in category-4 therapy. The elevated side-effects of MDR-TB therapies lead to treatment non-compliance and discontinuation of category-4 intervention. This eventually increases the frequency of MDR-TB-related comorbidities and mortality on a global scale. The clinicians and researchers require revisiting the already approved MDR-TB treatment regimens in the context of modifying the drugs’ combinations and/or dosages for decreasing the length of overall therapy while minimizing the risk of side effects. The researchers require undertaking prospective clinical trials to evaluate the therapeutic targets of unapproved MDR-TB treatment drugs in the context of optimizing the treatment combinations. Furthermore, the enhancement of drug susceptibility techniques and the thorough clinical examination of each MDR-TB case are highly required to effectively improve the overall quality of the selected antituberculosis therapy.

Keywords: MDR-TB, Drug-resistant, Tuberculosis, Pharmacotherapy, Adverse-Effects, Recommendations.

References:

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[2].     Azhar, G. S. (2012). DOTS for TB relapse in India: A systematic review. Lung India, 29(2), 147-153. doi:10.4103/0970-2113.95320.

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