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Abstract

This review provides a comprehensive overview of the crucial aspects of medicine effectiveness through clinical medicine evaluation. It covers the stages from clinical trials to post-marketing surveillance, and the factors that impact the balance between benefits and pitfalls of drugs. It also discusses the part of transnational collaboration and arising technologies in enhancing medicine safety. The review aims to inform healthcare professionals and cases about the current state and unborn directions of medicine development and evaluation

Keywords

Drug effectiveness, clinical trials, Regulatory approval, pharmacovigilance, Risk-benefit assessment.

Reference

  1. Talbot LA, Morrell CH, Metter EJ, Fleg JL. Comparison of cardiorespiratory fitness versus leisure time physical activity as predictors of coronary events in men aged \or = 65 years and [65 years. Am J Cardiol 2002;89:1187–92.
  2. Walsh JME, Pignone M. Drug treatment of hyperlipidemia in women. JAMA 2004;291:2243–52.
  3. Testa MA, Simonson DC. Current concepts: assessment of quality-of-life outcomes. N Engl J Med 1996;334:835–40.
  4. 4.  Wright EC. Non-compliance—or how many aunts has Mathilda? Lancet 1993;   342:909–913.
  5. Sclar DA. Improving medication compliance: a review of selected issues. Clin Ther 1991;13:436–440.
  6. Richardson JL, Shetton DR, Krailo M, et al. The effect of compliance with treatment on Survival among patients with hematologic malignancies. J Clin Oncol 1990;8:356–364.
  7. Epstein LH. The direct effects of compliance on health outcome. Health Psychol 1984;3:385–393
  8. Food, Drug and Cosmetic Act, Section 505.(d).
  9. Dagher R, Johnson J, William’s G et al. Accelerated approval of oncology Products: A decade of experience. J Natl Cancer Inst 2004;96:1500 –1509.
  10. Heilman RD. Drug development history, “over-View,” and what are GCPs? Quality Assur 1995;4: 75–9.
  11. Stave GM, Joines R. An overview of the pharmaceutical industry. Occup Med 1997;12:1– 4.
  12. Cancer Trials: Newdrugs, newdrug uses, and clinical trails. In: National Cancer Institute. Understanding trials. Posted 29 July 1999. Available at http://cancertrials.nci.nih.gov/understanding/indepth/fda/trials.html
  13. Friedman LM, Furberg CD, Demets DL.Fundamentals of clinical trials. 4th ed. New York: Springer Science+Business Media LLC; 2010.
  14. U.S. Food & Drug Administration. The Drug Development Process – Step 2:Preclinical Research. 2017.[cited 2017 September 10]. Available from: https://www.fda.gov/forpatients/approvals/drugs/ucm405658.htm.
  15. Leonard EM. Quality assurance and the drug development process: an FDA perspective. Quality Assur 1994;3:178 – 86
  16. Walters PG. FDA’s newdrug evaluation process: a general overview. J Public Health Dent 1992;52: 333–7.
  17. U.S. Food & Drug Administration.The Drug Development Process – Step 3:Clinical Research. 2017.[cited 2017 September 10]. Available from: https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm.
  18. Waller DG, Sampson T. Medical pharmacology and therapeutics E-Book. Elsevier Health Sciences; 2017.
  19. Federal Food Drug and Cosmetics Act. P.L.75-717, x505© and (d). 75th Cong (1938).
  20. Thaul S. How FDA approves drugs and regulates their safety and effectiveness. CRS report for Congress. Congressional Research Service. July 25, 2012. Available at: http://fas.org/sgp/crs/misc/R41983.pdf. Accessed March 4, 2016.
  21. U.S. Food and Drug Administration. New Drug Application (NDA). Available at: http://www.Fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Approval Applications/NewDrugApplicationNDA/default.htm. Accessed March 4, 2016
  22. Dimasi JA, Grabowski GH, Hansen RW. Innovation in the pharmaceutical industry: new Estimates of R&D costs. J Health Econ 2016;47: 20–33.
  23. U.S. Food and Drug Administration. FDA’s drug Review process: continued. Drug review steps Simplified. Available at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.Htm. Accessed March 4, 2016.
  24. Vlahovi?-Pal?evski V and Mentzer D. Postmarketing surveillance. In: Seyberth H, Rane A and Schwab M (eds) Pediatric clinical pharmacology. Berlin: Springer-Verlag, 2011,  pp.339–351.
  25. Hartzema AG, Porta MS, Tilson HH, et al. Adverse drug events: identification and attribution. Drug Intell Clin Pharm 1987; 21: 915–920.
  26.  Spelsberg A, Prugger C, Doshi P, et al. Contribution of industry funded post-marketing Studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ 2017; 356: j337.
  27. Pierce CE, Bouri K, Pamer C, et al. Evaluation of Facebook and Twitter monitoring to detect safety signals for medical products: an analysis of recent FDA safety alerts. Drug Saf 2017; 40: 317–331.
  28. Watanabe T and Narukawa M. Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan. Springerplus 2016; 5: 905.
  29.  Zhang X, Zhang Y, Ye X, et al. Overview of phase IV clinical trials for postmarket drug Safety surveillance: a status report from the ClinicalTrials.gov registry. BMJ Open 2016; 6: E010643.
  30. WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva: World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines.
  31. Klepper MJ. The periodic safety update report as a pharmacovigilance tool. Drug Saf 2004;27:569-78.
  32. Livio F, Renard D, Buclin T. Pharmacovigilance. Rev Med Suisse 2012;8:116-9
  33. Pharmacovigilance. Mann RD, Andrews EB, eds. John Wiley & Sons Ltd, Chichester, 2002.
  34. Harmark L, van Grootheest AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64:743-52.
  35. Biswas P, Biswas A. Setting standards for proactive pharmacovigilance in India: The way forward. Ind J Pharmacol 2007;39:124-8.
  36. Skalli S, Soulaymani Bencheikh R. Safety monitoring of herb-drug interactions: a component of pharmacovigilance. Drug Saf 2012;35:785-91.
  37.  Arnott J, Hesselgreaves H, Nunn AJ, Peak M, Pirmohamed M, Smyth RL, et al. What can we learn from parents about enhancing participation in pharmacovigilance?. Br J Clin Pharmacol 2012; in press.
  38. Gerritsen R, Faddegon H, Dijkers F, van Grootheest K, van Puijenbroek E. Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods. Drug Saf 2011;34:755-62.
  39. Kshirsagar N, Ferner R, Figueroa BA, Ghalib H, Lazdin J. Pharmacovigilance methods in public health programmes: the example of miltefosine and visceral leishmaniasis. Trans R Soc Trop Med Hyg 2011;105:61-7
  40. The importance of pharmacovigilance. Geneva: World Health Organization; 2002.
  41. Joshi SR, Sapatnekar SM. Pharmacovigilance in India: how safe are the new drugs? How sure are we?. J Assoc Physicians Ind 2008;56:933-4.
  42. Olsson S. Pharmacovigilance training with focus on India. Ind J Pharmacol 2008;40: S28-S30.
  43. WHO, Pharmacovigilance: ensuring the safe use of medicines, Geneva: WHO 2004.
  44. The Importance of Pharmacovigilance, WHO 2002.
  45. FDA. Drug safety annual report to the nation 2006. Available from: http://www.fda.gov/cder/ [Accessed October 31, 2007].
  46. FDA. FDA issues final risk minimization guidance 2005. Available from: http://www.fda.gov/bbs/topics/news/2005 [Accessed October 31, 2007].
  47. FDA. Premarketing risk assessment guidance 2005. Available from: http://www.fda.gov/cder/guidance [Accessed October 31,2007].
  48. FDA. Development and use of risk minimization action plans 2005. Available from: http://www.fda.gov/cder/guidance [Accessed October 31, 2007].
  49. FDA. Good pharmacovigilance practices and pharmacoepidemiologic assessment 2005. Available from: http://www.fda.gov/cder/guidance [Accessed October 31, 2007].
  50. Callreus T. The precautionary principle and pharmaceutical risk management. Drug Saf 2005;28:465–71.
  51. FDA. FDA Amendment Act 2007. Available from: http://www.fda.gov/oc/initiatives/HR3580.pdf [Accessed January 2, 2009].
  52. Strom BL. How the US drug safety system should be changed.JAMA 2006;295:2072–5.
  53. Ray WA, Stein CM. Reform of drug regulation—beyond an independent drug-safety board. N Engl J Med 2006;354:194–201.
  54. Schmitt S, Lis Y, Carter M. Benefit risk assessment during research and development. In: Schmitt S, ed. Risk-Based Compliance Handbook (Chapter 7). Baltimore, MD: PDA/DHI Pub-lisher, 2008.
  55. Okie S. Safety in numbers—monitoring risk in approved drugs. N Engl J Med 2005;352:11736.
  56. Veatch RM. Benefit risk assessment: what patients can know that scientists cannot. Drug Info J 1993;27:1021–9.
  57. Bahri P, Tsintis P, Waller PC. Regulatory pharmacovigilance in the EU. In: Mann R, Andrews E, eds. Pharmacovigilance (2nd ed.) (Chapter 14). Hoboken, NJ: Wiley, 2007.
  58. European Medicine Agency (EMEA) CHMP. Reflection paper on benefit–risk assessment in the context of the evaluation of marketing authorization applications of medicincal products forhuman use. Available from: http://www.emea.europa.eu/pdfs/human/brmethods/1540407en.pdf [Accessed March 19, 2008].
  59. Guo JJ, Goehring E, Jones JK. The story of cisapride and its withdraw from market: a case study. In: Hartzema AG, Tilson HH, Chan AK, eds. Pharmacoepidemiology and Therapeutic RiskManagement (Chapter 29). Cincinnati, OH: Harvey Whitney Books, 2008.
  60. Gould AL. Practical pharmacovilance analysis and strategies. Pharmacoepidemiol Drug Saf 2003;12:559–74.
  61. Drugs and Cosmetics Rules, 1945 (amended till 30th June 2005). Part IX. Labelling and packing of drugs other than homeopathic medicines. Rule 94 – 106 [cited 2006 Mar 20]. Available from: http://www.cdsco.nic.in/html/Drugs&CosmeticAct.pdf. P115-129
  62. US Food and Drug Administration. New OTC drug facts label. FDA Consumer Magazine, 2002 Jul-Aug. [cited 2006 Mar 20]. Available from: http://0www.fda.gov.lilac.une.edu/fdac/features/2002/402_otc.html
  63. CCL Industries Inc. FDA drug facts: impact and options. [cited 2006 Mar 20]. Available from: http://www.cc;omd/cp,/label_market_drug_facts.html
  64. Commonwealth of Australia. Therapeutic Goods Act 1989 [cited 2006 Mar 20]. Available from: http://www.tga.gov.au
  65. The Research Council for Complementary Medicine [homepage on the Internet]. Bodeker Gerard C. Traditional health systems and national policy [updated 2003 Nov; cited 2006 Mar 20]. Available from: http:// www.rccm.org.uk/static/Article_Gerry_Bodekar.aspx
  66. Insel PA. Analgesics, antipyretics and anti-inflammatory drugs. In:Goodman and Gilman, editors. The pharmacological basis of  Therapeutics. 9th ed. New York: McGraw-Hill; 1996. P631-633.
  67.  Marinker M, Blenkinsopp A, Bond C et al. (eds) From Compliance to Concordance: Achieving Shared Goals in Medicine Taking. London: Royal Pharmaceutical Society of Great Britain, 1997.
  68. Erickson SR, Kirking DM, Sandusky M. Michigan Medicaid recipients’ perceptions of medication counsealing as required by OBRA ’90. Journal of the American Pharmaceutical Association, 1998; 38: 333–338
  69. Meystre-Agustoni G. Antiretroviral therapies from the patient’s perspective. AIDS Care, 2000; 12:717–721.
  70. Smith-Dupre AA, Beck CS. Enabling patients and physicians to pursue multiple goals in health care encounters: a case study. Health Communication, 1996; 8: 73–90
  71. Bultman DC, Svarstad BL. Effects of physician communication style on client medication beliefs and adherence with antidepressant treatment. Patient Education and Counseling, 2000; 40: 173–185.
  72. Siminoff LA, Ravdin P, Colabianchi N, Sturm CMS. Doctor-patient communication patterns in breast Cancer adjuvant therapy discussions. Health Expectations, 2000; 3: 26–36.
  73. Britten N, Stevenson FA, Barry CA, Barber N,Bradley CP. Misunderstandings in prescribing decisions in general practice: qualitative study. British Medical Journal, 2000; 320: 484–488.
  74. Barry CA, Bradley CP, Britten N, Stevenson FA,Barber N. Patients  unvoiced agendas in general Practice consultations: qualitative study. British Medical Journal, 2000; 320: 1246–1250.
  75. Gergel IP. Research & development re-imagined: how Endo is leveraging intellectual arbitrage to build global partners for value creation in R&D. Presented at: US-India BioPharma & Health-care Summit; June 23, 2011; Cambridge, Massachusetts.
  76. The Global Fund. The Global Fund to fight AIDS, tuberculosis and malaria. Available at: http://www.theglobalfund.org/en/about/whoweare/. Accessed August 30, 2012.
  77. Buse K, Walt G. Global public-private partnerships, part I: a new development in health? Bull World Health Organ. 2000;78:549-561.
  78. US Food and Drug Administration, et al. Real-World Evidence. 2022. https://www.fda.gov/science-research/science-and-research-special topics/real-world-evidence. Accessed 1 Sep 2022.
  79. Wikipedia. Real world data. 2022. https://en.wikipedia.org/wiki/Real_world_data. Accessed 19 Mar 2022.

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Tejas S. kapase
Corresponding author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Yashraj Narake
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Omkar Gongane
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Sourabh patil
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Sachin Navale
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Nilesh Chougule
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

Tejas Kapase*, Yashraj Narake, Omkar Gongane, Sourabh Patil, Sachin Navale, Nilesh Chougule, Drug Effectiveness Through Clinical Drug Evaluation -Recent Study, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 354-366. https://doi.org/10.5281/zenodo.10528912

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