Adaptive Trial Design: Could We Use This Approach to Improve Clinical Trials in the Field of Global Health?

Trudie Lang Global Health Clinical Trials Programme, Centre for Tropical Medicine, University of Oxford, Oxford, United Kingdom

Search for other papers by Trudie Lang in
Current site
Google Scholar
Restricted access

We need more clinical trials in the world's poorest regions to evaluate new drugs and vaccines, and also to find better ways to manage health issues. Clinical trials are expensive, time consuming, and cumbersome. However, in wealthier regions these limiting factors are being addressed to make trials less administrative and improve the designs. A good example is adaptive trial design. This innovation is becoming accepted by the regulators and has been taken up by the pharmaceutical industry to reduce product development times and costs. If this approach makes trials easier and less expensive surely we should be implementing this approach in the field of tropical medicine and international health? As yet this has rarely been proposed and there are few examples. There is a need for raising the awareness of these design approaches because they could be used to make dramatic improvements to clinical research in developing countries.

Author Notes

*Address correspondence to Trudie Lang, Global Health Trials, Centre for Tropical Medicine, CCVTM, Churchill Hospital, Old Road, Headington, Oxford, OX7 3LU. E-mail:

Financial support: No specific funding has been received for this article. The author is funded and employed by the Centre for Tropical Medicine, University of Oxford, which receives core funding from the Wellcome Trust.

Author's address: Trudie Lang, Global Health Clinical Trials Programme, Centre for Tropical Medicine, University of Oxford, Oxford, UK, E-mail:

  • 1.

    Nelson NJ, 2010. Adaptive clinical trial design: has its time come? J Natl Cancer Inst 102: 12171218.

  • 2.

    Pullman DW, Wang X, 2001. Adaptive design, informed consent and the ethics of research. Control Clin Trials 22: 203210.

  • 3.

    Mehta C, Gao P, Bhatt DL, Harrington RA, Skerjanec S, Ware JH, 2009. Optimizing trial design: sequential, adaptive, and enrichment strategies. Circulation 119: 597605.

  • 4.

    Jahn-Eimermacher A, Ingel K, 2009. Adaptive trial design: a general methodology for censored time to event data. Contemp Clin Trials 30: 171177.

  • 5.

    Berry DA, 2007. Adaptive trial design. Clin Adv Hematol Oncol 5: 522524.

  • 6.

    Brown CH, Ten Have TR, Jo B, Dagne G, Wyman PA, Muthén B, Gibbons RD, 2009. Adaptive designs for randomized trials in public health. Annu Rev Public Health 30: 125.

  • 7.

    FDA, 2010. Guidance for Industry: Adaptive Design for Drugs and Biologicals.

  • 8.

    Dragalin V, 2006. Adaptive designs: terminology and classification. Drug Information Journal 40: 425435.

  • 9.

    Fegan GW, Lang TA, 2008. Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Med 5: e6.

  • 10.

    Nadol P, Stinson KW, Coggin W, Naicker M, Wells CD, Miller B, Nelson LJ, 2008. Electronic tuberculosis surveillance systems: a tool for managing today's TB programs. Int J Tuberc Lung Dis 12: 816.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11.

    Abayomi A, Goodridge W, Asika O, 2006. Wireless networks for surveillance, data capture and data management in the human immunodeficiency virus epidemic care and treatment programs. Afr J Med Med Sci 35 (Suppl): 149152.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12.

    Gonzalez Moran F, Munoz Criado I, Vanaclocha H, 2008. Real time information. A necessary tool in epidemiological surveillance. Gac Sanit 22: 162167.

  • 13.

    Abu-Hasaballah K, James A, Aseltine RH Jr, 2007. Lessons and pitfalls of interactive voice response in medical research. Contemp Clin Trials 28: 593602.

  • 14.

    Lang T, Chilengi R, Noor RA, Ogutu B, Todd JE, Kilama WA, Targett GK, 2008. Data safety and monitoring boards for African clinical trials. Trans R Soc Trop Med Hyg 102: 11891194.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15.

    Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MKB, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AE, Wallace SA, DAMOCLES Study Group, 2005. Issues in data monitoring and interim analysis of trials. Health Technol Assess 9: 1238, iii–iv.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16.

    Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J, 2006. Adaptive designs in clinical drug development—an Executive Summary of the PhRMA Working Group. J Biopharm Stat 16: 275283.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17.

    Liu Q, Proschan MA, Pledger GW, 2002. A unified theory of two-stage adaptive designs. J Am Stat Assoc 97: 10341041.

  • 18.

    Lang TA, White NJ, Hien TT, Farrar JJ, Day NP, Angus BJ, Denis E, Merson L, Cheah PY, Kimutai R, Marsh K, 2010. Clinical research in resource-limited settings: enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis 4: e619.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19.

    Lang TA, Kokwaro GO, 2008. Malaria drug and vaccine trials in Africa: obstacles and opportunities. Trans R Soc Trop Med Hyg 102: 710.

  • 20.

    Wang M, Wu YC, Tsai GF, 2008. A regulatory view of adaptive trial design. J Formos Med Assoc 107: 38.

  • 21.

    Hung HM, O'Neill RT, Wang SJ, Lawrence J, 2006. A regulatory view on adaptive/flexible clinical trial design. Biom J 48: 565573.

  • 22.

    Schluger N, Karunakara U, Lienhardt C, Nyirenda T, Chaisson R, 2007. Building clinical trials capacity for tuberculosis drugs in high-burden countries. PLoS Med 4: e302.

  • 23.

    Razzouk D, Sharan P, Gallo C, Gureje O, Lamberte EE, de Jesus Mari J, Mazzotti G, Patel V, Swartz L, Olifson S, Levav I, de Francisco A, Saxena S; WHO-Global Forum for Health Research Mental Health Research Mapping Project Group, 2010. Scarcity and inequity of mental health research resources in low-and-middle income countries: a global survey. Health Policy 94: 211220.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24.

    Mwaba P, Bates M, Green C, Kapata N, Zumla A, 2010. Research capacity strengthening in African countries. Lancet 375: 1874.

  • 25.

    Dolgin E, 2010. African networks launch to boost clinical trial capacity. Nat Med 16: 8.

Past two years Past Year Past 30 Days
Abstract Views 144 117 15
Full Text Views 4913 154 2
PDF Downloads 146 5 0
Affiliate Membership Banner
Research for Health Information Banner
Society Publishers Coalition Banner