View Article

Abstract

Clinical trials test potential treatments in human volunteers (subjects) to see whether they should be approved for wider use in the general population. India stood as a global hub for clinical trials in past years due to various factors. In this paper we discuss about clinical trials and clinical trials in India. Clinical trials are classified into different types based on their objectives, such as treatment trials, prevention trials, diagnostic trials, and others. Each type aims to address specific research questions related to the intervention's effectiveness. Clinical trials typically progress through several phases (Phase I to Phase IV) to evaluate different aspects like safety, dosage, efficacy, and potential side effects of the intervention. Each phase serves a specific purpose in the research process. Efficiency in clinical trials refers to conducting trials in a cost-effective and timely manner. Effectiveness assesses how well an intervention works in real-world conditions compared to its efficacy in controlled settings. Blinding involves concealing certain information from participants, researchers, or both, to minimize bias. Randomization ensures that participants are allocated randomly to different treatment groups, enhancing the validity and reliability of trial results.

Keywords

Types of clinical trial, Phases of clinical trial ,Clinical trail in India, Efficacy and effectiveness, Randomization, Blinding.

Reference

  1. Koran, L. M.: The reliability of clinical methods, data and judgments. N Engl J Med 293: 642-646, 695-701 (1975).
  2. Cay, E. L., et al.: Patient's assessment of the result of surgery for peptic ulcer. Lancet 1: 29-31 (1975).
  3. Kulkarni S. K., Hand Book of Experimental Pharmacology, 3rd ed, Vallabh Prakashan New Delhi, 2004, 21.
  4. http://www.temple.edu/pascope/about_trials.htm
  5. Clinical trial Wikipedia, the free encyclopedia .Available from: URL http://en.wikipedia.org/ wiki/clinical-trial.
  6. ICH Harmonized Tripartite Guideline for Good Clinical Practice ‘Academy For Clinical Excellence’.
  7. Maxwell C, Domenet JG, Joyce CRR.1971. Instant experience in clinical trials:a novel aid to teaching by simulation. J.Clin. Pharmacol. 11(5):323–31
  8. Marsh BT. 1975. The planning of a clini-cal trials workshop. Br. J. Clin. Phar-macol. 2(5):455–61
  9. Madsen BW, Woodings TL, Ilett KF,Shenfield GM, Potter JM, et al. 1978.Clinical trial experience by simulation: aworkshop report. Br. Med. J. 2(6148):1333–35
  10.  Bland JM. 1986. Computer simulation ofclinical trial as an aid to teaching the concept of statistical significance. Stat. Med.5:193–97
  11. Pocock SJ, Simon R. 1975. Sequentialtreatment assignment with balancing forprognostic factors in the controlled clinical trial. Biometrics 31(1):103–15
  12.  Jones DR. 1979. Computer simulation asa tool for clinical trial design. Int. J. BioMed. Comp. 10:145–50
  13. DeMets DL. 1981. Practical aspects ofdecision making in clinical trials: the coronary drug project as a case study. Control Clin. Trials 1(4):363–76
  14. Lee KL, Frederick M, Starmer CF, HarrisPJ, Rosati RA. 1980. Clinical judgementand statistics: lessons from a simulatedrandomized trial in coronary artery disease. Circulation 61(3):508–15
  15. Hippocrates. (Various works from the Hippocratic Corpus)
  16. Laennec, R.T.H. (1819). "De l’Auscultation Médiate."
  17. Osler, W. (1892). "The Principles and Practice of Medicine."
  18. Sackett, D.L. et al. (2000). "Evidence-Based Medicine: How to Practice and Teach EBM."
  19. Various studies and research publications on diagnostic accuracy and clinical method evaluation in medical journals (e.g., New England Journal of Medicine, JAMA, The Lancet).
  20. The Lancet (2009). "Phase 0 trials: A platform for drug development?". The Lancet. 374 (9685): 176–118
  21. Yang, Z. J., et al. (2010). "Motivation for Health Information Seeking and Processing About Clinical Trial Enrollment." Health Communication 25(5): 423-436.
  22. Life Sciences Strategy Group, (May 2009) "Clinical Trial Technology Utilization, Purchasing Preferences & Growth Outlook" Syndicated Publication.
  23. "India: Prime Destination for Unethical Clinical Trials". Common Dreams.
  24. Paul J, Seib R, Prescott T (Mar 2005). "The Internet and Clinical Trials: Background, Online Resources, Examples and Issues" (Free full  text).Journal of medical Internet research. 7 (1): e5.
  25. ICH Guideline for Good Clinical Practice: Consolidated Guidance
  26. Ginsberg HN, Kris-Etherton P, Dennis B, Elmer PJ, Ershow A, Lefevre M, Pearson T, Roheim P, Ramakrishnan R, Reed R Effects of reducing dietary saturated fatty acids on plasma lipids and lipoproteins in healthy subjects: the DELTA study, protocol 1 Arterioscler Thromb Vasc Biol, 18 (3) (1998), pp. 441-449
  27. Berglund L, Lefevre M, Ginsberg HN, Kris-Etherton PM, Elmer PJ, Stewart PW, Ershow A, Pearson TA, Dennis BH, Roheim PS Comparison of monounsaturated fat with carbohydrates as a replacement for saturated fat in subjects with a high metabolic risk profile: studies in the fasting and postprandial states.
  28. Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM A clinical trial of the effects of dietary patterns on blood pressure
  29. Appel LJ, Sacks FM, Carey VJ, Obarzanek E, Swain JF, Miller ER, Conlin PR, Erlinger TP, Rosner BA, Laranjo NM Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial
  30. Sacks FM, Carey VJ, Anderson CA, Miller ER, Copeland T, Charleston J, Harshfield BJ, Laranjo N, McCarron P, Swain J Effects of high vs low glycemic index of dietary carbohydrate on cardiovascular disease risk factors and insulin sensitivity: the OmniCarb randomized clinical trial
  31. Howard BV, Van Horn L, Hsia J, Manson JE, Stefanick ML, Wassertheil-Smoller S, Kuller LH, LaCroix AZ, Langer RD, Lasser NL Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial
  32. Appel LJ., Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial
  33. Altman DG, Bland JM. How to randomise. BMJ. 1999; 319: 703-704.
  34. Altman DG, Bland JM. How to randomise. BMJ. 1999; 319: 703-704.
  35. Altman DG, Bland JM. How to randomise. BMJ. 1999; 319: 703-704.
  36. Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011; 4: 8-11
  37.  Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: Bling: Who, what, when, why, how? Can J Surg. 2010; 53: 345-348.
  38. [Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: Blinding: Who, what, when, why, how? Can J Surg. 2010; 53: 345-348.]
  39. Lim HJ, Hoffmann RG. Study design: The basics. Methods Mol Biol. 2007; 404: 1-17
  40. Neutel JM and Smith DHG. Evaluation of angiotensin II receptor blockers for 24-hour blood pressure control: meta-analysis of a clinical database. J Clin Hypertens. 2003; 5(1): 58-63.
  41. Wan M., Orlu-Gul M., Legay H., Tuleu C. Blinding in pharmacological trials: The devil is in the details. Arch. Dis. Child. 2013;98:656—659. doi: 10.1136/archdischild-2013-304037.
  42. Blader J.C. Can keeping clinical trial participants blind to their study treatment adversely affect subsequent care? Contemp. Clin. Trials. 2005;26:290—299. doi: 10.1016/j.cct.2005.01.003.
  43. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887-1892.
  44. Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359(9300):57-61.

Photo
Shreyash kirankumar koli
Corresponding author

Department of pharmacology, Ahokrao Mane institute of pharmacy Ambap 416112, India.

Photo
Sourabh Patil
Co-author

Department of pharmacology, Ahokrao Mane institute of pharmacy Ambap 416112, India.

Photo
Sarthak kothali
Co-author

Department of pharmacology, Ahokrao Mane institute of pharmacy Ambap 416112, India.

Photo
Suvarna Deshmukh
Co-author

Department of pharmacology, Ahokrao Mane institute of pharmacy Ambap 416112, India.

Photo
Sachin Navale
Co-author

Department of pharmacology, Ahokrao Mane institute of pharmacy Ambap 416112, India.

Photo
Nilesh Chougle
Co-author

Department of pharmacology, Ahokrao Mane institute of pharmacy Ambap 416112, India.

Shreyash Koli, Sourabh Patil, Sarthak Kothali, Suvarna Deshmukh, Sachin Navale, Nilesh chougule, Effectiveness of clinical method evaluation, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 264-273. https://doi.org/10.5281/zenodo.10517844

More related articles
Herbal Body Wash...
Sayali Ingulkar , Ragini Salunke, ...
Liquid Liquid Separation And Determination Of Beta...
Edebi N. Vaikosen, Ruth C. Worlu, Samuel J. Bunu, Ebiere Dode, Ma...
Teneligliptin- An Effective Dipeptidyl Peptidase â...
Prudence A. Rodrigues, Irine Thomas, ...
Overview Of Liposomes: Versatile Nanocarriers For Drug Delivery And Beyond...
Taufik Mulla, Heer Trivedi, Sumukh Vasist, Mokshi Rana, ...
A Review on: Polyherbal Hand wash...
Pathan Shain Mahemood, N. S. Pendbhaje, Sonali D. More, Smeeta L. Chandre, ...
Melatonin Loaded Nanocarriers...
Raslamol K., Saranya K. G., Amayasree Suresh, Archa Ani, A. S. Athira, Febiya Joy, Gayathri Prasad, ...
More related articles
Herbal Body Wash...
Sayali Ingulkar , Ragini Salunke, ...
Liquid Liquid Separation And Determination Of Betamethasone, Clotrimazole And Ne...
Edebi N. Vaikosen, Ruth C. Worlu, Samuel J. Bunu, Ebiere Dode, Mary Doctor, ...
Herbal Body Wash...
Sayali Ingulkar , Ragini Salunke, ...
Liquid Liquid Separation And Determination Of Betamethasone, Clotrimazole And Ne...
Edebi N. Vaikosen, Ruth C. Worlu, Samuel J. Bunu, Ebiere Dode, Mary Doctor, ...