Open Access
Subscription Access
Open Access
Subscription Access
Recent Trends in Clinical Trials: An Overview
Subscribe/Renew Journal
Clinical research is the study design intended to check the safety and efficacy of drugs through the important phases, generally conducted in human volunteers to provide safe medications that contribute to well being of humanity. Generally a effective clinical trial study follows certain guidelines issued by ICH-GCP policies. These guidelines and policies are designed for protecting the interest of subjects and obtaining valuable information about the drug in clinical trial. Many research designs are implemented to obtain scientific information about the research study since it is tedious and expensive.
Keywords
Clinical trials, Preclinical studies, Phases of clinical trials, Good clinical practice, study design.
Subscription
Login to verify subscription
User
Font Size
Information
- S. B. Thorat, S. K. Banarjee, D. D. Gaikwad, S. L. Jadhav, R. M. Thorat. clinical trial: a review, International Journal of Pharmaceutical Sciences Review and Research, 2010; 1(2):101-106, SSN 0976 – 044X.
- C. Vijayabanu, R. Renganthan, S H Shahana Hameedha, J. Arokiya Monica;. Clinical Trials in Digital Era on Pharmaceutical Industry. Research Journal of Pharmacy. and Technology 2017; 10(11): 4047-4050.
- Thakur Abhimanyu, Kondru Sushmita, Kamilya Shruti, Kumar Amit, Goldar Epshita. Assessment of Prevailing Insurance Policies and Regulations in Context of Clinical Research Industry. Asian Journal of Pharmaceutical Research. 5(2): April-June 2015; Page 114-117.
- Patel Minesh, G.S. Chakraborthy. A Role of Clinical Trial in Management of Hypertension and Medication of Hypertension. Research Journal of Pharmacy and Technology. 2021; 14(6):3215-2.
- Ankur Rohilla, Ravi Kumar Singh, Deepti Sharma, Rahul Keshari and Ashok Kushnoor. Phases of clinical trials: a review, international journal of pharmaceutical, chemical and biological sciences, 2013; 3(3): 700-703. ISSN: 2249-9504.
- Dr Arun bhatt, Evolution of clinical research: a history before and beyond James lind., Perspective in clinical research, jan 2010 vol 1, issue 1, pg: 6- 10.4. Medical research council. Streptomycin treatment of pulmonary tuberculosis. British Medical Journal, October 30 (1948), 2: 769-82.
- Lind J. A treatise of the scurvey. Edinburgh: sands murray Cochran, canadian medical association journal: January 6, 2009. 180 (1). (1753) 191- 3.
- Archana B. Chavhan, Dipali M. Bhoi. Pharmacovigillance: Drug Safety Monitoring. Asian Journal of Pharmacy and Technology. 2019; 9(1):49-52.
- Shobhit Prakash Srivastava, Ankit Singh, A Systematic Review: Good Clinical Practice, International Journal of Pharmaceutical Technology and Biotechnology, 2017; 4(2):17-32. ISSN:2394-2371
- Debjit Bhowmik, Margret Chandira, Chiranjib.B, emerging trends of scope and opportunities clinical trials in India, International Journal of Pharmacy and Pharmaceutical Sciences. 2010; 2(1). 7-20.
- Ashish a. Gawai, Faisal Shaikh, Mangesh Gadekar, Nitin Deokar, Shivanand Kolhe, K. R. Biyani. A Review on: Phase ‘0’ Clinical Trials or Exploratory Investigational New Drug. Turkish journal of pharmaceutical science. 2017; 14(1):84-89. DOI: 10.4274/tjps.63935.
- Shivam Ganesh Patil, Prof. Wasmate Dhanraj N, Dr.Shyamlila B Bawage. Clinical Trails. International Journal of Research Publication and Reviews. 2021. 2(9). 752-755. ISSN 2582-7421
- Chris Frampton, Shaun Holt, Clinical Trials – An Overview. Research Review. educational series. 2012. 1-6.
- A guide to phase 1 clinical trial design, written by Statistical consultancy team, wed, oct 17, 2018. Available at : https://www.quanticate.com/blog/bid/65234/phase-1-clinical-trial-designpart-1. 2022.
- Kulkarni S. K., Hand Book of Experimental Pharmacology, 3rd edition, Vallabh Prakashan New Delhi, 2004, 21.
- Purvi Gandhi. Clinical Research Methodology. Indian Journal of Pharmaceutical Education and Research. 2011; 45(2): 199-209.
- Clinical trials registry-India national institute of medical statistics, clinical trials registry of India Bulletin, Vol.10 July-Dec. 2012 and vol. 11 Jan –June 2013.
- Food and Drug administration, Available at: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/whatare-different-types-clinical-research. 2022.
- Central Drugs Standard Control Organization. Available from: https://www.cdscoonline.gov.in/CDSCO/homepage. Last accessed on 2022. jan 15.
- Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian J Anaesth 2017; 61:192- 9.
- Haroon Rashid, Clinical trial regulations in india: past, present and future, journal of medical science, 2017; 20(1): 5-17.
- Novitzke JM. The significance of clinical trials. J Vasc Interv Neurol 2008; 1(1):31.
- Indian Council of Medical Research, New Delhi. Available from: http://www.icmr.nic.in/. [Last accessed on 2017 Feb 20.
- Vishal Vennu, Prem Saini. The Perception and Perspectives of Researchers from Different Zones On India's Current Clinical Trials Rules. Research Journal of Pharmacy and Technology. 2020; 13(11):5654-5658.
- Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: A narrative review. Postgrad Med. 2011; 123:194-204.
- Brian L.Strom, Stephen E.Kennel, Sean Hennessy. Text book of pharmacoepidemiology. Published by Wiley Black Well, UK, 2013.
- Marlies Noordzij a Friedo W. Dekker b Carmine Zoccali c Kitty J. Jager a. Study Designs in Clinical Research. Nephron Clinical Practice. 2009. ;113:c218–c221. DOI: 10.1159/000235610.
- R C Goyal. Research methodology for health professionals. Published by Jaypee Brothers medical publishers (P) Ltd, New Delhi, India, 2013.
- Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011; 9:672-677.
- Ranjan Das, P N Das. Biomedical research methodology. Published by Jaypee Brothers medical publishers (P) Ltd, New Delhi, India; 2011
- P S S Sundar Rao, J Richard. Introduction to biostatistics and research methodology. Published by Phi Learning (P) Ltd, New Delhi, India, 2009.
- Chidambaram AG, Josephson M. Clinical research study designs: The essentials. Paediatric Invest. 2019; 3:245-252. https://doi.org/10.1002/ped4.12169.
- G Parthasarathi, Karin Nyfort Hansen, Milap Nahata. A text book of clinical pharmacy. Published by Universities Press (P) Ltd, Hyderabad, 2013.
- Center for Disease Control and Prevention Principles of Epidemiology in Public Health Practice, 3rd ed, Published by U.S Department of Health and Human Services, 2010.
- K G Revi Kumar, B D Miglani. A text book of pharmacy practice. Published by Career Publications, Maharashtra, India, 2012.
- Justin Besen, Stephanie D Gan. A critical evaluation of clinical research study designs. Journal of Investigative Dermatology, 134, 2014.
- Lim HJ, Hoffmann RG. Study design: The basics. Methods Mol Biol. 2007; 404:1-17.
- Prasad K. Fundamentals of Evidence Based Medicine. 2nd ed. India: Springer India; 2013.
- Peat J, Barton B. Medical Statistics: A Guide to Data Analysis and Critical Appraisal. 1st ed. India: Blackwell Publishing Ltd.; 2005.
- Sibbald B, Roberts C. Understanding controlled trials. Crossover trials. BMJ. 1998; 316:1719.
- Montgomery A A, peters T J, little P 2003. Design, analysis and presentation of factorial randomised controlled trials. Biomed Central Medical Research Methodology 3:26.
- Margetts BM, Nelson M. Design concepts in nutritional epidemiology. 2nd ed. Oxford University Press; 1997:415- 417.
- Piedra-Fernández JM, Ganoza-Guerrero GE. Field trials and community trials: importance in public health. Medwave 2016 Dic; 16(11): e6797 doi: 10.5867/medwave.2016.11.6797.
- dos Santos-Silva I. Cancer Epidemiology. Principles and methods. Francia. International Agencyfor Research on Cancer, 1999 [on line).
- Smith P, Morrow R, Ross D. Field trials of health interventions: A Toolbox. 3° Ed. Reino Unido. London school of hygiene and tropical medicine. 2015.
- Margetts BM, Nelson M. Design concepts in nutritional epidemiology. 2nd ed. Oxford University Press; 1997:415- 417.
- P S S Sundar Rao, J Richard. Introduction to biostatistics and research methodology. Published by Phi Learning (P) Ltd, New Delhi, India, 2009.
- EMEA (2000) Clinical Investigation of Medicinal Products in the Pediatric Population.
- EMEA (2002) ICH Topic E 6 (R1): Guideline for Good Clinical Practice.
- Textbook of Pharmaceutical Analysis, 4th edition, Dr. S. Ravi sankar, Edition. 2010, published by: Rx publications, Tirunelveli, india, ISBM 978- 93-5156-371-6.
- Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research Journal of Pharmacy and Technology 2020; 13(3):1517-1522.
- Otte A, Maier-Lenz H, Dierckx RA (2005) Good Clinical Practice: Historical background and key aspects. Nucl Med Commun 26: 563-574.
- Raghava Ramesh Narayana, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami. ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP). Research journal of Pharmacology and Pharmacodynamics. 2010; 2(1):27-32.
- Dominguez-Urban I (1997) Harmonization in the regulation of pharmaceutical research and human rights: the need to think globally. Cornell Int Law J 30: 245-286.
- Vijayananthan A, Nawawi O (2008) The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J 4: e5.
- Lovely Joylen Castelino, Anoop Narayanan V, Swapnil Dylan Fernandes, Pankaj Kumar, Sandeep D S. Good Clinical Practices: An Indian Perspective. Research journal of Pharmacy and Technology 2018; 11(7): 3209-3215
- Food and Drug Administration, Available at: http://www.fda.gov/downloads/Training/CDRHLearn/UCM176414.pdf. 2022.
- Nilima Kanwar Hada, Mahendra Singh Ashawat. Ethical Conduct of Paediatric Clinical Trials; Issues and Challenges. Research. Journal of Pharmaceutical Dosage Forms and Technology. 6(3): July- Sept. 2014; Page 156-160.
- Ravindra B. Ghooi, The Nuremberg code-A critique, perspective in clinical research, April-june 2011, Vol 2, issue 2, pg: 72-76.
- Lovely Joylen Castelino, Anoop Narayanan V, Swapnil Dylan Fernandes, Pankaj Kumar, Sandeep D S. Good Clinical Practices: An Indian Perspective. Research Journal of Pharmacy and Technology. 2018; 11(7): 3209-3215.
Abstract Views: 147
PDF Views: 0