Current Science

Open Access Open Access  Restricted Access Subscription Access

The Many Uses of Data in Public Clinical Trial Registries


Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India
 

Registries were primarily set up to (i) increase the enrollment in trials and (ii) decrease the bias in the published literature. Additionally, scholars have used registry data to answer a wide range of questions, related to: (i) transparency and information dissemination; (ii) healthcare; (iii) science; (iv) biomedical innovation; (v) the ethics of the trial enterprise; (vi) fulfilling regulatory requirements; (vii) the economic implications of clinical studies; (viii) the globalization of the trial enterprise and (ix) holding biomedical journals to account. With the help of numerous examples, I have documented some of these actual, or occasionally potential, uses of registry data. We should be aware of these many uses since they highlight the importance of (a) establishing and maintaining registries, (b) ensuring that trial records are comprehensive and accurate, and (c) funding research on registry data, and facilitating such research in other ways.

Keywords

Clinical Trial, Ethics, Innovation, Registry, Transparency.
User
Notifications
Font Size

  • Dickersin, K. and Rennie, D., Registering clinical trials. JAMA, 2003, 290, 516–523.

  • Zarin, D. A., Tse, T., Williams, R. J. and Rajakannan, T., Update on trial registration 11 years after the ICMJE policy was established. New Engl. J. Med., 2017, 376, 383–391.

  • Fleminger, J. and Goldacre, B., Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register. PLoS ONE, 2018, 13, e0193088.

  • Venugopal, N. and Saberwal, G., A comparative analysis of important public trial registries, and a proposal for an interim ideal one. PLoS ONE, 2021, 16, e0251191.

  • Scherer, M. and Trelle, S., Opinions on registering trial details: a survey of academic researchers. BMC Health Serv. Res., 2008, 8, 18.

  • Tharyan, P., George, A. T., Kirubakaran, R. and Barnabas, J. P., Reporting of methods was better in the Clinical Trials RegistryIndia than in Indian journal publications. J. Clin. Epidemiol., 2013, 66, 10–22.

  • Taichman, D. B. et al., Editorial – sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. Ethiop. J. Health Sci., 2016, 26, 2.

  • DeVito, N. J., French, L. and Goldacre, B., Noncommercial funders’ policies on trial registration, access to summary results, and individual patient data availability. JAMA, 2018, 319, 1721.

  • Miller, J. E., Ross, J. S., Moch, K. I. and Caplan, A. L., Characterizing expanded access and compassionate use programs for experimental drugs. BMC Res. Notes, 2017, 10, 350.

  • Pillamarapu, M., Mohan, A. and Saberwal, G., An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry-India. Trials, 2019, 20, 535.

  • Askie, L. M. et al., The Clinical Trials Landscape in Australia 2006–2015. Australian New Zealand Clinical Trials Registry, Sydney, 2017.

  • Hunter, K. E. et al., The Clinical Trials Landscape in New Zealand 2006–2015, Australian New Zealand Clinical Trials Registry, Sydney, 2018.

  • Trends, Charts, and Maps – ClinicalTrials.gov; https:// clinicaltrials.gov/ct2/resources/trends.

  • Ongoing Trials • Coronavirus; https://coronavirus.tghn.org/covidtherapeutictrials/covid-ongoing-trials/.

  • Doshi, P., Jefferson, T. and Del Mar, C., The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med., 2012, 9, e1001201.

  • Li, M. D., Atkins, H. and Bubela, T., The global landscape of stem cell clinical trials. Regen. Med., 2014, 9, 27–39.

  • Research Integrity: Clinical Trials Transparency, House of Commons Science and Technology Committee, 2018, p. 30.

  • International Standards for Clinical Trial Registries, World Health Organization, 2012; https://apps.who.int/iris/handle/10665/ 76705.

  • Chaturvedi, M., Gogtay, N. and Thatte, U., Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India. Perspect. Clin. Res., 2017, 8, 172.

  • Feizabadi, M., Fahimnia, F., Mosavi Jarrahi, A., Naghshineh, N. and Tofighi, S., Iranian clinical trials: An analysis of registered trials in International Clinical Trial Registry Platform (ICTRP). J. Evid. Based Med., 2017, 10, 91–96.

  • Viergever, R. F., Terry, R. F. and Karam, G., Use of data from registered clinical trials to identify gaps in health research and development. Bull. WHO, 2013, 91, 416–425C.

  • Egleston, B. L. et al., Characteristics of clinical trials that require participants to be fluent in English. Clin. Trials, 2015, 12, 618–626.

  • Cook, W. A. and Doorenbos, A. Z., Indications of recruitment challenges in research with US Military Service Members: a ClinicalTrials. gov review. Mil. Med., 2017, 182, e1580–e1587.

  • Shields, K. E. and Lyerly, A. D., Exclusion of pregnant women from industry-sponsored clinical trials. Obstet. Gynecol., 2013, 122, 1077–1081.

  • Puthumana, J., Miller, J. E., Kim, J. and Ross, J. S., Availability of investigational medicines through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Netw. Open, 2018, 1, e180283.

  • Subherwal, S. et al., Clinical trials in peripheral vascular disease. Circulation, 2014, 130, 1812–1819.

  • Russo, L. A. T. et al., Impact of regulatory assessment on clinical studies in Brazil. AMB Rev. Assoc. Med. Bras., 2016, 62, 447–453.

  • Zou, C. X. et al., Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials, 2018, 19, 581.

  • Goldacre, B. et al., COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials, 2019, 20, 118.

  • Gopal, A. D. et al., Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals. Trials, 2018, 19, 448.

  • Hunter, K. E., Seidler, A. L. and Askie, L. M., Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey. BMJ Open, 2018, 8, e019983.

  • Pandey, A., Aggarwal, A., Seth, S. D., Maulik, M. and Juneja, A., Strengthening ethics in clinical research. Indian J. Med. Res., 2011, 133, 339.

  • Carlisle, B., Kimmelman, J., Ramsay, T. and MacKinnon, N., Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin. Trials, 2015, 12, 77–83.

  • Tan, A. et al., Robotic surgery: disruptive innovation or unfulfilled promise? A systematic review and meta-analysis of the first 30 years. Surg. Endosc., 2016, 30, 4330–4352.

  • Tse, T., Fain, K. M. and Zarin, D. A., How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider. BMJ, 2018, 361, k1452.

  • van Valkenhoef, G., Loane, R. F. and Zarin, D. A., Previously unidentified duplicate registrations of clinical trials: an exploratory analysis of registry data worldwide. Syst. Rev., 2016, 5, 116.

  • Kumari, S., Mohan, A. and Saberwal, G., Hidden duplicates: 10s or 100s of Indian trials, registered with ClinicalTrials.gov, have not been registered in India, as required by law. PLoS ONE, 2020, 15, e0234925.

  • Transforming Clinical Research in the United States: Challenges and ... – Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation – Google Books.

  • Drain, P. K., Parker, R. A., Robine, M. and Holmes, K. K., Global migration of clinical research during the era of trial registration. PLoS ONE, 2018, 13, e0192413.

  • Who’s sharing their clinical trial results? FDAAA Trials Tracker; http://fdaaa.trialstracker.net/.

  • Glasziou, P. et al., Reducing waste from incomplete or unusable reports of biomedical research. The Lancet, 2014, 383, 267–276.

  • Gresham, G. K., Ehrhardt, S., Meinert, J. L., Appel, L. J. and Meinert, C. L., Characteristics and trends of clinical trials funded by the National Institutes of Health between 2005 and 2015. Clin. Trials, 2018, 15, 65–74.

  • Porter, B., Horizon scanning: How shoddy clinical trial reporting undermines health policy making. Transparimed, 2019, March 4.

  • Nader, J. H., Neel, D. V., Shulman, D. S., Ma, C., Bourgeois, F., and DuBois, S. G., Landscape of phase 1 clinical trials for minors with cancer in the United States. Pediatr. Blood Cancer, 2020, 67, e28694.

  • Shorter, D., Domingo, C. B. and Kosten, T. R., Emerging drugs for the treatment of cocaine use disorder: a review of neurobiological targets and pharmacotherapy. Expert Opin. Emerg. Drugs, 2015, 20, 15–29.

  • Okada, K. and Sengoku, S., Entry into new therapeutic areas: the effect of alliance on clinical trials. Ther. Innov. Regul. Sci., 2019, 53, 648–653.

  • Turner, L., ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies. Regen. Med., 2017, 12, 705–719.

  • Williams, R. J., Tse, T., DiPiazza, K. and Zarin, D. A., Terminated Trials in the ClinicalTrials.gov results database: evaluation of availability of primary outcome data and reasons for termination. PLoS ONE, 2015, 10, e0127242.

  • Tatsioni, A., Karassa, F. B., Goodman, S. N., Zarin, D. A., Fanelli, D. and Ioannidis, J. P. A., Lost evidence from registered large long-unpublished randomized controlled trials: a survey. Ann Intern Med., 2019, 171, 300–301.

  • Infant milk: Nestle’s clinical trial under scanner – The Hindu; https://www.thehindu.com/news/national/infant-milk-nestlesclinicaltrial-under-scanner/article28809296.ece.

  • Doua, Y. J., Dominicus, H., Mugwagwa, J., Gombe, S. M. and Nwokike, J., Scarce quality assurance documentation in major clinical trial registries for approved medicines used in postmarketing clinical trials. Trials, 2019, 20, 212.

  • Das, S., Rousseau, R., Adamson, P. C. and Lo, A. W., New business models to accelerate innovation in pediatric oncology therapeutics: a review. JAMA Oncol., 2018, 4, 1274–1280.

  • Keezhupalat, S. M., Naik, A., Gupta, S., Srivatsan, R. and Saberwal, G., An analysis of sponsors/collaborators of 69,160 drug trials registered with ClinicalTrials.gov. PLoS ONE, 2016, 11, e0149416.

  • Murthy, S., Mandl, K. D. and Bourgeois, F. T., Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013. Health Res. Pol. Syst., 2015, 13, 28.

  • Thiers, F. A., Sinskey, A. J. and Berndt, E. R., Trends in the globalization of clinical trials. Nat. Rev. Drug Discov., 2008, 7, 13–14.

  • Hoekman, J., Frenken, K., de Zeeuw, D. and Heerspink, H. L., The geographical distribution of leadership in globalized clinical trials. PLoS ONE, 2012, 7, e45984.

  • Alvarenga, L. S. and Martins, E. N., Biopharmaceutical industrysponsored global clinical trials in emerging countries. AMB Rev. Assoc. Med. Bras., 2010, 56, 428–433.

  • De Angelis, C., Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Can. Med. Assoc. J., 2004, 171, 606–607.

  • Mathieu, S., Comparison of registered and published primary outcomes in randomized controlled trials. JAMA, 2009, 302, 977.


Abstract Views: 189

PDF Views: 74




  • The Many Uses of Data in Public Clinical Trial Registries

Abstract Views: 189  |  PDF Views: 74

Authors

Gayatri Saberwal
Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India

Abstract


Registries were primarily set up to (i) increase the enrollment in trials and (ii) decrease the bias in the published literature. Additionally, scholars have used registry data to answer a wide range of questions, related to: (i) transparency and information dissemination; (ii) healthcare; (iii) science; (iv) biomedical innovation; (v) the ethics of the trial enterprise; (vi) fulfilling regulatory requirements; (vii) the economic implications of clinical studies; (viii) the globalization of the trial enterprise and (ix) holding biomedical journals to account. With the help of numerous examples, I have documented some of these actual, or occasionally potential, uses of registry data. We should be aware of these many uses since they highlight the importance of (a) establishing and maintaining registries, (b) ensuring that trial records are comprehensive and accurate, and (c) funding research on registry data, and facilitating such research in other ways.

Keywords


Clinical Trial, Ethics, Innovation, Registry, Transparency.

References





DOI: https://doi.org/10.18520/cs%2Fv120%2Fi11%2F1686-1691