Advertisement

Healthcare Patient and Clinical Research

  • Stefan Kendzierskyj
  • Hamid JahankhaniEmail author
Chapter
Part of the Advanced Sciences and Technologies for Security Applications book series (ASTSA)

Abstract

Clinical trials and research are a very involved and often lengthy process with formalities and regulations that should be adhered to. There are questions over the transparency of clinical research data from the start of the initial process of registration, informed consent, clinical outcomes and to where approval is given by post marketing and publication. These impacts suggested have manifested itself in the form of fraud, misconduct, selective reporting, bias and consequently had other effects to those taking approved drugs; some resulting in fatalities. Access to research data has also been difficult to obtain from those involved in the clinical trials such as patients and even researchers whom would be interested in the post marketing phase and pharmaceutical analysis. Evidence is presented with data extracted from credible sources that highlight the concerns in registration, informed consent and clinical research outcomes and how they are reported with recent example of how opioids misuse has ended up as a serious issue as a consequence of non-transparency. This Chapter suggests a theoretical model to propose how blockchain could present a more transparent and secure method to tackle the issues mentioned, with utilising blockchain as the mechanism/framework for clinical research institutions, regulation and non-regulation bodies, pharmaceutical organisations, drug manufacturers/suppliers and patients.

Keywords

Clinical research Clinical trials Clinical outcomes Fraud and misconduct Selective reporting Bias Blockchain Data integrity Traceability Smart wearables Cyber-attacks Data breaches Opioids misuse 

References

  1. AllTrials (2013) GSK statement. [Online]. Available at http://www.alltrials.net/supporters/organisations/gsk-statement/. Accessed 30 May 2018
  2. Bellon T (2018) U.S. state lawsuits against Purdue Pharma over opioid epidemic mount. [Online]. Available at https://www.reuters.com/article/us-usa-opioids-litigation/u-s-state-lawsuits-against-purdue-pharma-over-opioid-epidemic-mount-idUSKCN1IG2WU. Accessed 16 June 2018
  3. Benchoufi M, Ravaud P (2017) Blockchain technology for improving clinical research quality. Trials 18:335. Available at  https://doi.org/10.1186/s13063-017-2035-z. Accessed 20 Oct 2018
  4. Bourgeois F, Murthy S, Mandl KD, (2010) Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153(3):158–166. Available at  https://doi.org/10.7326/0003-4819-153-3-201008030-00006. Accessed 20 Oct 2018CrossRefGoogle Scholar
  5. ClinicalTrials.gov (2018) Trends, charts and map. [Online]. Available at https://clinicaltrials.gov/ct2/resources/trends. Accessed 1 June 2018
  6. Cohen D (2018a) The opioid timebomb. [Online]. Available at https://opioids.standard.co.uk/#article. Accessed 16 June 2018
  7. Cohen D (2018b) The opioid timebomb: how addiction to painkillers cost me my wife, my children, my home and my £150,000-a-year job. [Online]. Available at https://www.standard.co.uk/news/uk/the-opioid-timebomb-how-addiction-to-painkillers-cost-me-my-wife-my-children-my-home-and-my-a3791006.html. Accessed 16 June 2018
  8. COMPare Trials Project (2016) Goldacre B, Drysdale H, Powell-Smith A., et al. www.COMPare-trials.org. [Online]. Available at http://compare-trials.org/results. Accessed 1 June 2018
  9. DrugPatentWatch (2017) Can blockchain technology put an end to counterfeit drugs. [Online]. Available at https://medium.com/drugpatentwatch/can-blockchain-technology-put-an-end-to-counterfeit-drugs-c4087e652fe0. Accessed 20 Oct 2018
  10. Engelhardt M (2017) Hitching healthcare to the chain: an introduction to blockchain technology in the healthcare sector. Technol Innov Manag Rev 7(10): 22–34. Available at  https://doi.org/10.22215/timreview/1111. Accessed 20 Oct 2018CrossRefGoogle Scholar
  11. Goldacre B (2013) Are clinical trial data shared sufficiently today? No. BMJ, Br Med J (online) 347: 1–3. Available at  https://doi.org/10.1136/bmj.f1880. Accessed 20 Oct 2018CrossRefGoogle Scholar
  12. Gupta A (2013) Fraud and misconduct in clinical research: a concern. Perspect Clin Res 4(2). Available at  https://doi.org/10.4103/2229-3485.111800. Accessed 20 Oct 2018CrossRefGoogle Scholar
  13. Hurley R (2017) Drugs caused record number of deaths in England and Wales in 2016. BMJ, Br Med J 358. [Online]. Available at https://search.proquest.com/docview/1925754408?accountid=12860.  https://doi.org/10.1136/bmj.j3750. Accessed 16 June 2018
  14. Liang X, et al (2017) Integrating blockchain for data sharing and collaboration in mobile healthcare applications. 2017 IEEE 28th annual international symposium on personal, indoor, and mobile radio communications (PIMRC), Montreal, QC, pp 1–5. Available at  https://doi.org/10.1109/PIMRC.2017.8292361. Accessed 20 Oct 2018
  15. Logvinov V (2014) Clinical trials transparency and the trial and experimental studies transparency (TEST) act. Contemp Clin Trials 37(2): 219–224. Available at  https://doi.org/10.1016/j.cct.2014.01.001. Accessed 20 Oct 2018CrossRefGoogle Scholar
  16. Matthews-King A (2018) Breast cancer screening: 450,000 women missed out on checkup invitations due to IT error, Jeremy Hunt admits. [Online]. Available at https://www.independent.co.uk/news/health/jeremy-hunt-breast-cancer-screening-inquiry-nhs-women-invitations-missing-a8332446.html. Accessed 18 June 2018
  17. Moore A et al (2013) Expect analgesic failure; pursue analgesic success. BMJ, Br Med J (Online) 346. Available at https://search.proquest.com/docview/1945757929?accountid=12860.  https://doi.org/10.1136/bmj.f2690. Accessed 16 June 2018CrossRefGoogle Scholar
  18. National Center for Biotechnology Information (2018) [Online]. Available at https://www.ncbi.nlm.nih.gov/. Accessed 20 Oct 2018
  19. Prayle A, Hurley M, Smyth A (2012) Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ, Br Med J 344. [Online]. Available at  https://doi.org/10.1136/bmj.d7373. Accessed 20 Oct 2018CrossRefGoogle Scholar
  20. Proehl J, Hoyt S (2017) Integrity and transparency in reporting clinical trials. Adv Emerg Nurs J 39(1): 1–2. Available at  https://doi.org/10.1016/j.jen.2017.01.009. Accessed 20 Oct 2018CrossRefGoogle Scholar
  21. Public Eye (2013) Clinical trials. [Online]. Available at https://www.publiceye.ch/en/topics-background/health/clinical-trials/. Accessed 20 Oct 2018
  22. Ramírez J (2013) Lack of transparency in clinical trials: a call for action. Colomb Méd, CM 44(4): 243–246. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4002000/. Accessed 20 Oct 2018
  23. Ross J, Gross C, Krumholz H (2012) Promoting transparency in pharmaceutical industry-sponsored research. Am J Public Health 102(1): 72–80 Available at  https://doi.org/10.2105/AJPH.2011.300187. Accessed 20 Oct 2018CrossRefGoogle Scholar
  24. Seife C (2015) Research misconduct identified by the US Food and Drug Administration. [Online]. Available at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2109855?alert=article. Accessed 10 June 2018CrossRefGoogle Scholar
  25. Song F, et al (2010) Dissemination and publication of research findings: an updated review of related basics. Health Technol Assess 14(8). Available at  https://doi.org/10.3310/hta1480. Accessed 20 Oct 2018
  26. Viergever RF, Ghersi D (2011) The quality of registration of clinical trials. PLoS One 6(2). Available at http://dx.plos.org/10.1371/journal.pone.0014701. Accessed 10 June 2018CrossRefGoogle Scholar
  27. Viergever R, Karam G, Reis A, Ghersi D (2014) The quality of registration of clinical trials: still a problem. PLoS One 9(1): 1–12. Available at  https://doi.org/10.1371/journal.pone.0084727. Accessed 20 Oct 2018CrossRefGoogle Scholar
  28. Wager E et al (2013) Hardly worth the effort? Medical journals’ policies and their editors’ and publishers’ views on trial registration and publication bias: quantitative and qualitative study. BMJ 347: f524. Available at  https://doi.org/10.1136/bmj.f5248. Accessed 10 June 2018CrossRefGoogle Scholar
  29. Zarin D et al (2011) The ClinicalTrials.gov results database—update and key issues. N Engl J Med 3;364(9): 852–860. Available at  https://doi.org/10.1056/NEJMsa1012065. Accessed 20 Oct 2018CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.London CampusNorthumbria UniversityLondonUK

Personalised recommendations