COMPREHENSIVE ANALYSIS OF CLINICAL TRIALS IN PAKISTAN FROM SEPTEMBER 1992 TO FEBRUARY 2019
DOI:
https://doi.org/10.55519/JAMC-03-8793Abstract
Background: Clinical trials are conducted to evaluate interventions (drugs, medical devices, surgical methods and radiation treatment) for treating diseases or conditions. They may also be done to prevent the development or prevent recurrence or determining risk factors. We wanted to review the current status of clinical trials in Pakistan. Methods: On searching ClinicalTrials.gov, registered clinical trials conducted in Pakistan from September 1992 to February 2019 were reviewed. The analysis evaluated the characteristics of the clinical studies including the type of intervention, geographic distribution of studies, anticipated enrolment and number of participants, blinding, allocation status, lead sponsors, age group, study type, recruitment status, gender, study results, study phase, primary purpose and subject distribution. The results were tabulated with frequencies and percentages provided by category. Results: There were 508 registered clinical trials conducted in Pakistan from September 1992 to February 2019. Interventional clinical trials were conducted more often than observational trials (77.2% and 22.8% respectively), with drugs (41.4%) as the most common intervention. The majority of registered trials had participants ranging between 101-1000 (47.2%) with most having no blinding in their methodology (34.1%). Most of the trials conducted were randomized (66.5%) while few (5.3%) were non-randomized. Among the sponsor categories, 66.5% of the trials belong to the ‘Other’ (non-governmental, non-industry) category. Although 59.6% of the registered trials have been completed, most of them (91.3%) did not report their results. Treatment intervention trials in Internal Medicine were the most common primary purpose. An increasing trend in the frequency of clinical trials was also evident. Conclusion: The number of clinical trials in Pakistan showed an increasing trend over the time period studied, which may reflect on the general outlook of clinical research in the country. Most clinical trials were sponsored by universities, hospitals and non-profit organizations but less than 10% of studies reported resultsReferences
Learn About Clinical Studies - ClinicalTrials.gov [Internet]. [cited 2019 April 15]. Available from: https://clinicaltrials.gov/ct2/about-studies/learn
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312(7023):71–2.
Sibbald B, Roland M. Understanding controlled trials. Why are randomised controlled trials important? BMJ 1998;316(7126):201.
The James Lind Library - Illustrating the development of fair tests of treatments in health care [Internet]. The James Lind Library. [cited 2019 April 15]. Available from: https://www.jameslindlibrary.org/
Woolf SH. The meaning of translational research and why it matters. JAMA 2008;299(2):211–3.
Kendall JM. Designing a research project: randomised controlled trials and their principles. Emerg Med J 2003;20(2):164–8. Ref no 6&17 are same
McCray AT, Ide NC. Design and implementation of a national clinical trials registry. J Am Med Inform Assoc 2000;7(3):313–23.
National Institutes of Health Launches ClinicalTrials.gov Results Database. [Internet]. [cited 2019 April 15]. Available from: http://www.nlm.nih.gov/news/expanded_clinicaltrials.html
Gillen JE, Tse T, Ide NC, McCray AT. Design, implementation and management of a web-based data entry system for ClinicalTrials.gov. Stud Health Technol Inform 2004;107(Pt 2):1466–70.
Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2005;353(26):2779–87.
Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA 2007;297(19):2112–20.
The Word Bank, Pakistan Data. [Internet]. [cited 2019 April 15]. Available from: https://data.worldbank.org/country/pakistan
Pakistan Population (2021) - Worldometer [Internet]. [cited 2019 April 15]. Available from: https://www.worldometers.info/world-population/pakistan-population/
Current health expenditure (% of GDP) - Pakistan | Data [Internet]. [cited 2019 April 15]. Available from: https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS?locations=PK&name%20desc=false
Global Health Observatory. 2013. Pakistan: Country Profile. Geneva, Switzerland: World Health Organization. [Internet]. [cited 2019 April 15]. Available from: http://www.who.int/gho/countries/pak/en/
Irumnaz A, C Nair S. Clinical trials in Pakistan: Opportunities and challenges. Appl Clin Res Clin Trials Regul Aff 2014;1(1):23–7.
Kendall JM. Designing a research project: randomised controlled trials and their principles. Emerg Med J 2003;20(2):164–8. Ref no 6&17 are same
Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in Clinical Trials. gov, 2007-2010. JAMA 2012;307(17):1838–47.
Kris MG, Meropol NJ, Winer EP. Accelerating progress against cancer: ASCO’s blueprint for transforming clinical and translational cancer research. [Internet]. American Society of Clinical Oncology. [cited 2012 Feb 5]. Available from: http://www.asco.org/ascov2/department%20content/cancer%20policy%20and%20clinical%20affairs/downl oads/blueprint.pdf
Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med 1984;3(4):409–22.
Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol 1995;48(1):23–40.
Califf RM, DeMets DL. Principles from clinical trials relevant to clinical practice: part I. Circulation 2002;106(8):1015–21.
Jawad F. Clinical trial registry in Pakistan. [Internet]. [cited 2019 April 15]. Available from: https://jpma.org.pk/article-details/8802
Research and Development at GSK Pakistan - GlaxoSmithKlinec2001-2010. [Internet]. [cited 2013 Nov 21] Available from: http://www.gsk.com.pk/Research-and-Development/73/Researchand-Development-at-GSK-Pakistan. aspx
Zwierzyna M, Davies M, Hingorani AD, Hunter J. Clinical trial design and dissemination: comprehensive analysis of clinical trials. gov and PubMed data since 2005. BMJ 2018;361:k2130.
Osama M, Malik RJ, Azim ME. Clinical Trial Registry: An essential requirement for physical therapy and health researchers in Pakistan. J Pak Med Assoc 2018;68(7):1079–83.
Sherin A. Clinical trial registration: Can we establish a national clinical trial registry of Pakistan? Khyber Med J Univ J 2012;4(2):37–8.
Published
Issue
Section
License
Journal of Ayub Medical College, Abbottabad is an OPEN ACCESS JOURNAL which means that all content is FREELY available without charge to all users whether registered with the journal or not. The work published by J Ayub Med Coll Abbottabad is licensed and distributed under the creative commons License CC BY ND Attribution-NoDerivs. Material printed in this journal is OPEN to access, and are FREE for use in academic and research work with proper citation. J Ayub Med Coll Abbottabad accepts only original material for publication with the understanding that except for abstracts, no part of the data has been published or will be submitted for publication elsewhere before appearing in J Ayub Med Coll Abbottabad. The Editorial Board of J Ayub Med Coll Abbottabad makes every effort to ensure the accuracy and authenticity of material printed in J Ayub Med Coll Abbottabad. However, conclusions and statements expressed are views of the authors and do not reflect the opinion/policy of J Ayub Med Coll Abbottabad or the Editorial Board.
USERS are allowed to read, download, copy, distribute, print, search, or link to the full texts of the articles, or use them for any other lawful purpose, without asking prior permission from the publisher or the author. This is in accordance with the BOAI definition of open access.
AUTHORS retain the rights of free downloading/unlimited e-print of full text and sharing/disseminating the article without any restriction, by any means including twitter, scholarly collaboration networks such as ResearchGate, Academia.eu, and social media sites such as Twitter, LinkedIn, Google Scholar and any other professional or academic networking site.
