Top

Trials

Published in:

Open Access 01-12-2022 | Research

Data management in diabetes clinical trials: a qualitative study

Authors: Aynaz Nourani, Haleh Ayatollahi, Masoud Solaymani Dodaran

Published in: Trials | Issue 1/2022

Abstract

Background

Clinical trials play an important role in expanding the knowledge of diabetes prevention, diagnosis, and treatment, and data management is one of the main issues in clinical trials. Lack of appropriate planning for data management in clinical trials may negatively influence achieving the desired results. The aim of this study was to explore data management processes in diabetes clinical trials in three research institutes in Iran.

Method

This was a qualitative study conducted in 2019. In this study, data were collected through in-depth semi-structured interviews with 16 researchers in three endocrinology and metabolism research institutes. To analyze data, the method of thematic analysis was used.

Results

The five themes that emerged from data analysis included (1) clinical trial data collection, (2) technologies used in data management, (3) data security and confidentiality management, (4) data quality management, and (5) data management standards. In general, the findings indicated that no clear and standard process was used for data management in diabetes clinical trials, and each research center executed its own methods and processes.

Conclusion

According to the results, the common methods of data management in diabetes clinical trials included a set of paper-based processes. It seems that using information technology can help facilitate data management processes in a variety of clinical trials, including diabetes clinical trials.

Unnikrishnan R, Mohan V. Whither diabetes research in India today? Diabetes Metab Syndr. 2020;14(3):195–8. https://doi.org/10.1016/j.dsx.2020.02.007.CrossRefPubMed

Insel RA, Deecher DC, Brewer J. Juvenile Diabetes Research Foundation: mission, strategy, and priorities. Diabetes. 2012;61(1):30–5. https://doi.org/10.2337/db11-1398.CrossRefPubMed

Roden M. Clinical diabetes research: methods and techniques. Chichester: Wiley; 2007. https://doi.org/10.1002/9780470513095.CrossRef

Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of clinical trials. 5th ed. Cham: Springer International Publishing; 2015. https://doi.org/10.1007/978-3-319-18539-2.CrossRef

Akinyemi R. Data management in clinical research. Afr J Biomed Res. 2020;23(2):31–3.

Lu Z, Su J. Clinical data management: current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials. 2010;2:93–105. https://doi.org/10.2147/OAJCT.S8172.CrossRef

St Germain DC, Good MJ. Data management in clinical trials. In: Principles and practice of clinical research. London: Elsevier; 2018. p. 531–45.CrossRef

Gazali S, Kaur S, Singh I. Artificial intelligence based clinical data management systems: a review. Inform Med Unlock. 2017;9:219–29. https://doi.org/10.1016/j.imu.2017.09.003.CrossRef

Malik N, Jain N, Nagaich U. Clinical data management: tools and regulations. Int J Pharm Life Sci. 2018;9(3):8–15.

10.

Krishnankutty B, Bellary S, Kumar NBR, Moodahadu LS. Data management in clinical research: an overview. Indian J Pharmacol. 2012;44(2):168–72. https://doi.org/10.4103/0253-7613.93842.CrossRefPubMedPubMedCentral

11.

McFadden E. Management of data in clinical trials. Hoboken: John Wiley & Sons; 2007. https://doi.org/10.1002/9780470181287.CrossRef

12.

Richesson RL, Andrews JE. Clinical Research Informatics. 2nd ed. London: Springer; 2019. https://doi.org/10.1007/978-3-319-98779-8.CrossRef

13.

Kapritsou M. E-Clinical Trials: The future of clinical trials and how nurses can be involved. Asia Pac J Oncol Nurs. 2020;7(3):235–6. https://doi.org/10.4103/apjon.apjon_11_20.CrossRefPubMedPubMedCentral

14.

Pavlović I, Kern T, Miklavčič D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp Cin Trials. 2009;30(4):300–16. https://doi.org/10.1016/j.cct.2009.03.008.CrossRef

15.

Park JY, Kim DR, Haldar B, Mallick AH, Kim SA, Dey A, et al. Use of the data system for field management of a clinical study conducted in Kolkata, India. BMC Res Notes. 2016;9(1):20–31. https://doi.org/10.1186/s13104-015-1767-7.CrossRefPubMedPubMedCentral

16.

Johnson SB, Farach FJ, Pelphrey K, Rozenblit L. Data management in clinical research: synthesizing stakeholder perspectives. J Biomed Inform. 2016;60:286–93. https://doi.org/10.1016/j.jbi.2016.02.014.CrossRefPubMed

17.

Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, et al. Heterogeneity prevails: the state of clinical trial data management in Europe-results of a survey of ECRIN centres. Trials. 2010;11(1):79–88. https://doi.org/10.1186/1745-6215-11-79.CrossRefPubMedPubMedCentral

18.

Ngari MM, Waithira N, Chilengi R, Njuguna P, Lang T, Fegan G. Experience of using an open source clinical trials data management software system in Kenya. BMC Res Notes. 2014;7(1):845–53. https://doi.org/10.1186/1756-0500-7-845.CrossRefPubMedPubMedCentral

19.

Mosley M, Brackett M, Earley S, Henderson D. The DAMA guide to the data management body of knowledge. Bradley Beach: Technics publications; 2009.

20.

Walther B, Hossin S, Townend J, Abernethy N, Parker D, Jeffries D. Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data. PloS One. 2011;6(9):1–11. https://doi.org/10.1371/journal.pone.0025348.CrossRef

21.

Liu M, Davis K. A clinical trials manual from the Duke Clinical Research Institute: Lessons from a horse named Jim. Chichester: John Wiley & Sons; 2011. https://doi.org/10.1002/9781444315219.CrossRef

22.

Cheng AY, Lau DC. The Canadian Diabetes Association 2013, clinical practice guidelines—raising the bar and setting higher standards! Can J Diabetes. 2013;37(3):137–8. https://doi.org/10.1016/j.jcjd.2013.04.005.CrossRefPubMed

23.

Tucker K, Branson J, Dilleen M, Hollis S, Loughlin P, Nixon MJ, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16(1):77–84. https://doi.org/10.1186/s12874-016-0169-4.CrossRefPubMedPubMedCentral

24.

Gupta SK, Nayak RP. A background to collating and using trial data. In: Advances in collating and using trial data. London: Future Science Ltd; 2014. p. 6–19. https://doi.org/10.4155/ebo.13.600.CrossRef

25.

Rorie DA, Flynn RW, Grieve K, Doney A, Mackenzie I, MacDonald TM, et al. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology. Br J Clin Pharmacol. 2017;83(9):1880–95. https://doi.org/10.1111/bcp.13285.CrossRefPubMedPubMedCentral

26.

Richesson RL, Nadkarni P. Data standards for clinical research data collection forms: current status and challenges. JAMIA Open. 2011;18(3):341–6.

27.

Rahbar MH, Lee M, Hessabi M, Tahanan A, Brown MA, Learch TJ, et al. Harmonization, data management, and statistical issues related to prospective multicenter studies in ankylosing spondylitis (AS): experience from the Prospective Study of Ankylosing Spondylitis (PSOAS) cohort. Contemp Clin Trials Commun. 2018;11(1):127–35. https://doi.org/10.1016/j.conctc.2018.07.004.CrossRefPubMedPubMedCentral

28.

Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, et al. Standard requirements for GCP-compliant data management in multinational clinical trials. Trials. 2011;12(1):85–94. https://doi.org/10.1186/1745-6215-12-85.CrossRefPubMedPubMedCentral

29.

Kuchinke W, Karakoyun T. Pathway to improved data management in clinical trials. Clin Investig. 2014;4(6):501–5. https://doi.org/10.4155/cli.14.41.CrossRef

30.

Gao Q-B, Kong Y, Fu Z, Lu J, Wu C, Jin Z-C, et al. EZ-Entry: A clinical data management system. Comput Biol Med. 2008;38(9):1042–4. https://doi.org/10.1016/j.compbiomed.2008.07.008.CrossRefPubMed

31.

Cragg WJ, Cafferty F, Diaz-Montana C, James EC, Joffe J, Mascarenhas M, et al. Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper case report forms. Trials. 2019;20(1):241–52. https://doi.org/10.1186/s13063-019-3343-2.CrossRefPubMedPubMedCentral

32.

Richesson RL, Andrews JE. Introduction to clinical research informatics. In: Clinical research informatics. London: Springer; 2012. p. 3–16. https://doi.org/10.1007/978-1-84882-448-5_1.CrossRef

33.

Payne PRO. The clinical research environment. In: Richesson RL, Andrews JE, editors. Clinical research informatics. London: Springer; 2012. p. 3–16. https://doi.org/10.1007/978-1-84882-448-5_3.CrossRef

34.

Durkalski V, Zhao W, Dillon C, Kim J. A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression. Clin Trials J. 2010;7(2):174–82. https://doi.org/10.1177/1740774509358748.CrossRef

35.

Das S, Zijdenbos AP, Harlap J, Vins D, Evans AC. LORIS: a web-based data management system for multi-center studies. Front Neuroinform. 2011;5(37):1–11.

36.

Cramon P, Rasmussen ÅK, Bonnema SJ, Bjorner JB, Feldt-Rasmussen U, Groenvold M, et al. Development and implementation of PROgmatic: a clinical trial management system for pragmatic multi-centre trials, optimised for electronic data capture and patient-reported outcomes. Clin Trials. 2014;11(3):344–54. https://doi.org/10.1177/1740774513517778.CrossRefPubMed

37.

Inan O, Tenaerts P, Prindiville S, Reynolds H, Dizon D, Cooper-Arnold K, et al. Digitizing clinical trials. NPJ Digit Med. 2020;3(1):1–7. https://doi.org/10.1038/s41746-020-0302-y.CrossRef

38.

Coran P, Goldsack JC, Grandinetti CA, Bakker JP, Bolognese M, Dorsey ER, et al. Advancing the use of mobile technologies in clinical trials: recommendations from the clinical trials transformation initiative. Digit Biomark. 2019;3(3):145–54. https://doi.org/10.1159/000503957.CrossRefPubMedPubMedCentral

39.

Nourani A, Ayatollahi H, Solaymani-Dodaran M. A clinical data management system for diabetes clinical trials. J Healthc Eng. 2022. (In Press)

40.

Nourani A, Ayatollahi H, Solaymani-Dodaran M. A review of clinical data management systems used in clinical trials. Rev Recent Clin Trials. 2019;14(1):10–23. https://doi.org/10.2174/1574887113666180924165230.CrossRefPubMed

41.

Müller J, Heiss KI, Oberhoffer R. Implementation of an open adoption research data management system for clinical studies. BMC Res Notes. 2017;10(1):252–8. https://doi.org/10.1186/s13104-017-2566-0.CrossRefPubMedPubMedCentral

42.

Musick BS, Robb SL, Burns DS, Stegenga K, Yan M, McCorkle KJ, et al. Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults. Comput Inform Nurs. 2011;29(6):337–43. https://doi.org/10.1097/NCN.0b013e3181fcbc95.CrossRefPubMedPubMedCentral

43.

Tran V-A, Johnson N, Redline S, Zhang G-Q. OnWARD: Ontology-driven web-based framework for multi-center clinical studies. J Biomed Inform. 2011;44(1):48–53.CrossRef

44.

Li Z, Wen J, Zhang X, Wu C, Li Z, Liu L. ClinData Express–a metadata driven clinical research data management system for secondary use of clinical data. In: AMIA Annu Symp Proc. Chicago: American Medical Informatics Association; 2012.

45.

Arab L, Hahn H, Henry J, Chacko S, Winter A, Cambou MC. Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial. Contemp Clin Trials. 2010;31(2):138–46. https://doi.org/10.1016/j.cct.2009.11.005.CrossRefPubMed

46.

Wilson AS, Bacon PA, Young SP, Carruthers DM. Vasculitis integrated clinical assessment database: a data management system to support studies into systemic vasculitis. J Clin Rheumatol. 2010;16(1):10–4. https://doi.org/10.1097/RHU.0b013e3181c6813f.CrossRefPubMed

47.

Stenzhorn H, Weiler G, Brochhausen M, Schera F, Kritsotakis V, Tsiknakis M, et al. The ObTiMA system-ontology-based managing of clinical trials. In: MedInfo. Cape Town: IOS Press; 2010.

48.

Cavenaugh JS, Snell P, Jeffries D, Waight PA, McConkey SJ. A relational database for management of flow cytometry and ELISpot clinical trial data. Cytometry B Clin Cytom. 2007;72(1):49–62. https://doi.org/10.1002/cyto.b.20146.CrossRefPubMed

49.

Lee H, Chapiro J, Schernthaner R, Duran R, Wang Z, Gorodetski B, et al. How I do it: a practical database management system to assist clinical research teams with data collection, organization, and reporting. Acad Radiol. 2015;22(4):527–33. https://doi.org/10.1016/j.acra.2014.12.002.CrossRefPubMedPubMedCentral

50.

Nourani A, Ayatollahi H, Solaymani-Dodaran M. Clinical trial data management software: a review of the technical features. Rev Recent Clin Trials. 2019;14(3):160–72. https://doi.org/10.2174/1574887114666190207151500.CrossRefPubMed

51.

Chaturvedi N, Mehrotra B, Kumari S, Gupta S, Subramanya H, Saberwal G. Some data quality issues at ClinicalTrials. gov. Trials. 2019;20(1):378–84. https://doi.org/10.1186/s13063-019-3408-2.CrossRefPubMedPubMedCentral

52.

Nahm M. Data Quality in Clinical Research. In: Richesson RL, Andrews JE, editors. Clinical research informatics. London: Springer; 2012. p. 3–16. https://doi.org/10.1007/978-1-84882-448-5_10.CrossRef

53.

Knepper D, Fenske C, Nadolny P, Bedding A, Gribkova E, Polzer J, et al. Detecting data quality issues in clinical trials: current practices and recommendations. Ther Innov Regul Sci. 2016;50(1):15–21. https://doi.org/10.1177/2168479015620248.CrossRefPubMed

Title: Data management in diabetes clinical trials: a qualitative study
Authors: Aynaz Nourani
Haleh Ayatollahi
Masoud Solaymani Dodaran
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06110-5

2024 ASCO Annual Meeting

Springer Medicine

Data management in diabetes clinical trials: a qualitative study

Abstract

Background

Method

Results

Conclusion

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Method

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2022

Statistical analysis of publicly funded cluster randomised controlled trials: a review of the National Institute for Health Research Journals Library

DUDE - a universal prevention program for non-suicidal self-injurious behavior in adolescence based on effective emotion regulation: study protocol of a cluster-randomized controlled trial

StudyMe: a new mobile app for user-centric N-of-1 trials

Effectiveness of a mobile app-based educational intervention to treat internet gaming disorder among Iranian adolescents: study protocol for a randomized controlled trial

The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial

The effect of tourniquet application on the morphology and function of quadriceps in patients undergoing total knee arthroplasty: study protocol for a single-blind randomized controlled trial