head JofIMAB
Journal of IMAB - Annual Proceeding (Scientific Papers)
Publisher: Peytchinski Publishing Ltd.
ISSN: 1312-773X (Online)
Issue: 2021, vol. 27, issue1
Subject Area: Medicine
DOI: 10.5272/jimab.2021271.3619
Published online: 18 March 2021

Original article

J of IMAB. 2021 Jan-Mar;27(1):3619-3623
Liliya Bogdanova1ORCID logo Corresponding Autoremail, Valentina Belcheva2ORCID logo, Evgeni Grigorov1, 2ORCID logo,
1) National Center of Public Health and Analyses, Sofia, Bulgaria.
2) Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, Medical University-Varna, Bulgaria.

Purpose: The number of clinical trials conducted by the industry has increased significantly for the period 2014-2016. They have produced advances in disease prevention, treatment, and rehabilitation for many diseases. This was the main reason to carry a study on the association between certain demographic indexes and the number of clinical trials in the European economic area. Proving a correlation between those two variables could lead to additional research pursued by the industry during the feasibility phase of each study in order to have higher and quicker enrollment for the success of the clinical trial.
Materials/Methods: Three demographic factors were considered to have some importance on the clinical trial enrollment – the number of population, life expectancy at age 65 and Disability-Adjusted Life Years (DALY). The numbers were processed with Spearman‘rho, and the read of the results shows a correlation to be present for the number of population and life expectancy at age 65.
Results: There is a correlation between the number of clinical trials opened for enrollment of patients and certain demographic indexes, which could lead to favorable conditions for trial conduct in the different countries of EEA.
Conclusions: Studying in advance if some demographic factors are significant for conduct of clinical studies is something new that could be used by the industry to avoid the wastefulness of a clinical project.

Keywords: clinical trials, number of population, life expectancy at age 65, Disability-Adjusted Life Years (DALY),

pdf - Download FULL TEXT /PDF 503 KB/
Please cite this article as: Bogdanova L, Belcheva V, Grigorov E. Association between certain demographic indexes and the number of clinical trials in the European Economic Area. J of IMAB. 2021 Jan-Mar;27(1):3619-3623. DOI: 10.5272/jimab.2021271.3619

Corresponding AutorCorrespondence to:Liliya Bogdanova, PhD, MScPharm, MHM; 38, Kopenhagen str., Sofia 1582, Bulgaria; E-mail: lilly.bogdanova@gmail.com

1. Redmond JL. Understanding and addressing barriers to recruitment. Am J Manag Care. 2014 Mar;20(5 Spec No.):E13. [PubMed]
2. Grove A. Rethinking Clinical Trials. Science. 2011 Sep 23;333(6050):1679. [Crossref]
3.  Baquet CR, Henderson K, Commiskey P, Morrow JN. Clinical trials: the art of enrollment. Semin Oncol Nurs. 2008 Nov;24(4):262-9. [PubMed] [Crossref]
4. Nipp RD, Hong K, Paskett ED. Overcoming Barriers to Clinical Trial Enrollment. Am Soc Clin Oncol Educ Book. 2019 Jan;39:105-114. [PubMed] [Crossref]
5.  Ivanova E, Getov I, Lebanova H. Ethical Aspects of Vulnerable Group of Patients in Clinical Trials. In: Clinical Trials in Vulnerable Populations. Edited by Milica Prostran. IntechOpen. 2018. Chapter 8.  [Crossref]
6.  Kukreja JB, Thompson IM Jr., Chapin BF. Organizing a clinical trial for the new investigator. Urol Oncol. 2019 May;37(5):336-339. [PubMed] [Crossref]
7.  Morgan B, Hejdenberg J, Hinrichs-Krapels S, Armstrong D. Do feasibility studies contribute to, or avoid, waste in research? PLoS One. 2018 Apr 23;13(4):e0195951. [PubMed] [Crossref]
8. David FN, Mallows CL. The Variance of Spearman's Rho in Normal Samples. Biometrika. 1961 Jun;48(1-2):19-28. [Crossref]
9. Mondal MN, Shitan M. Relative importance of demographic, socioeconomic and health factors on life expectancy in low- and lower-middle-income countries. J Epidemiol. 2014; 24(2):117-24. [PubMed] [Crossref]
10.  Manolova Y, Vankova D, Grupcheva C. Patient–reported Outcomes–an Approach and Application in Amniotic Membraine Transplantation. Scr Sci Salut Publicae. 2017; 3(1):7-13.
11 Augustovski F, Colantonio LD, Galante J, Bardach A, Caporale JE, Zarate V, et al. Measuring the Benefits of Healthcare: DALYs and QALYs - Does the Choice of Measure Matter? A Case Study of Two Preventive Interventions. Int J Health Policy Manag. 2018 Feb 1;7(2):120-136. [PubMed] [Crossref]
12.  Shenoy P, Harugeri A.Elderly patients' participation in clinical trials. Perspect Clin Res. 2015 Oct-Dec;6(4):184-9. [PubMed] [Crossref]
13.  Vankova D, Mancheva P. Quality of life of individuals with disabilities - concepts and concerns. Scr Sci Salut Publicae. 2015; 1(1):21-8.
14.  Anand S, Hanson K. Disability-adjusted life years: a critical review. J Health Econ. 1997 Dec;16(6):685-702. [PubMed] [Crossref]
15. Cleophas TJ, Tavenier P. Clinical Trials in Chronic Diseases. J Clin Pharmacol. 1995 Jun;35(6):594–8. [PubMed] [Crossref].

Received: 15 April 2020
Published online: 18 March 2021

back to Online Journal