Publications

Publications

1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e8-general-considerations-clinical-trials
2. Zarin DA, Goodman SN, Kimmelman J. Harms from uninformative clinical trials. JAMA. 2019 Sep 3;322(9):813-4.
3. Rosala-Hallas A, Bhangu A, Blazeby J, Bowman L, Clarke M, Lang T, Nasser M, Siegfried N, Soares-Weiser K, Sydes MR, Wang D. Global health trials methodological research agenda: results from a priority setting exercise. Trials. 2018 Dec 1;19(1):48.
4. Tatsioni A, Karassa FB, Goodman SN, Zarin DA, Fanelli D, Ioannidis JP. Lost evidence from registered large long-unpublished randomized controlled trials: a survey. Annals of Internal Medicine. 2019 Aug 20;171(4):300-1.
5. Zheutlin AR, Niforatos J, Stulberg E, Sussman J. Research Waste in Randomized Clinical Trials: a Cross-Sectional Analysis. Journal of General Internal Medicine. 2019 Nov 12:1-3.
6. UK Medical Research Council. (2017). MRC Guidelines for Management of Global Health Trials Involving Clinical or Public Health Interventions. Retrieved 24 March 2020 from Joint Global Health Trials scheme: https://mrc.ukri.org/funding/science-areas/global-health-and-international-partnerships/funding-partnerships/joint-global-health-trials/.
7. Blagden SP, Billingham L, Brown LC, Buckland SW, Cooper AM, Ellis S, Fisher W, Hughes H, Keatley DA, Maignen FM, Morozov A. Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement. British Journal of Cancer. 2020 Jan 6:1-0

Target Policy Profile (TPoP)

Literature Cited

1. McCaul M, Clarke M, Bruijns SR, Hodkinson PW, et al. Global emergency care clinical practice guidelines: A landscape analysis. African Journal of Emergency Medicine. 2018 Dec 1;8(4):158-63.

Suggested Reading (current to February 2020)

• “The Many Meanings of Evidence: A Comparative Analysis of the Forms and Roles of Evidence Within Three Health Policy Processes in Cambodia,” by Wall et al., 2018 in Evidence Use in Health Policy Making
• “On the Path to UHC–Global Evidence Must Go Local to Be Useful: Comment on” Disease Control Priorities Third Edition Is Published: A Theory of Change Is Needed for Translating Evidence to Health Policy,” by Davis & Walker, 2019 in International Journal of Health Policy and Management
• “Health care must mean safe care: enshrining patient safety,” by Flott et al., 2017 in The Lancet
• “Modernising vaccine surveillance systems to improve detection of rare or poorly defined adverse events,” by Chandler, 2019 in BMJ
• “Apology and Unintended Harm in Global Health,” by Addis and Amon, 2019 in Health & Human Rights
• “A new database of the references on international clinical practice guidelines: a facility for the evaluation of clinical research,” by Eriksson et al., 2020 in Scientometrics
• “Global emergency care clinical practice guidelines: A landscape analysis,” by McCaul et al., 2018 in African Journal of Emergency Medicine
• “Implementing One Health approaches to confront emerging and re-emerging zoonotic disease threats: lessons from PREDICT,” by Kelly et al, 2020 in One Health Outlook
• “Global considerations on maternal vaccine introduction and implementation,” by Giles et al., 2020 in Maternal Immunization
• “We shouldn’t count chickens before they hatch: results-based financing and the challenges of cost-effectiveness analysis,” by Paul et al., 2020 in Critical Public Health
• “Results-based financing in health: From evidence to implementation,” by McIsaac et al., 2018 in Bulletin of the World Health Organization.
• “Developing the Global Health Cost Consortium unit cost study repository for HIV and TB: methodology and lessons learned,” by Plosky et al., 2019 in African Journal of AIDS Research
• “How is the use of research evidence in health policy perceived? A comparison between the reporting of researchers and policy-makers,” by Ellen et al., 2018, in Health Research Policy and Systems
• “Engaging Stakeholders, from Inception and Throughout the Study, is Good Research Practice to Promote use of Findings,” by Kalibala & Nutley, 2019 in Aids and Behavior
• “The role of policy actors and contextual factors in policy agenda setting and formulation: maternal fee exemption policies in Ghana over four and a half decades,” by Koduah et al., 2015 in Health Research Policy and Systems
• “Political Analysis for Health Policy Implementation,” by Campos & Reich, 2019 in Health Systems & Reform
• “Policy and Science for Global Health Security: Shaping the Course of International Health,” by Berger et al., 2019 in Tropical Medicine and Infectious Disease
• “The challenge of bridging the gap between researchers and policy makers: experiences of a Health Policy Research Group in engaging policy makers to support evidence informed policy making in Nigeria,” by Uzochukwu et al., in Globalization and Health, 2016.
• “Establishing research priorities in prevention and control of vector-borne diseases in urban areas: a collaborative process,” Dagenais et al., 2018, in Infectious Diseases of Poverty
• “Addressing inequity: neglected tropical diseases and human rights,” by Sun & Amon, 2018 in Health & Human Rights
• “Methods to promote equity in health resource allocation in low- and middle-income countries: an overview,” by Love-Koh et al., 2020 in Globalization and Health
• “The Lancet Commission on Global Health Law: The Transformative Power of Law to Advance the Right to Health,” by Gostin, 2019 in the Journal of Global Health Science
• “Future of health policy & systems research: transitioning from Millennium Developmental Goals to Sustainable Developmental Goals for improving health,” by Feroz et al., 2017 in Future of Health Policy & Systems Research
• “Evidence map of knowledge translation strategies, outcomes, facilitators and barriers in African health systems,” by Edwards et al, 2019 in Health Research Policy and Systems
• Moscou K, Kohler JC. “Pharmacogovernance: Advancing Pharmacovigilance and Patient Safety.” Social and Administrative Aspects of Pharmacy in Low-and Middle-Income Countries. 2018 Jan 1 (pp. 403-418). Academic Press.

Protocol Registry

Literature Cited or Suggested Reading

Chan, A. W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., Doré, C. J., Parulekar, W. R., Summerskill, W. S., Groves, T., Schulz, K. F., Sox, H. C., Rockhold, F. W., Rennie, D., & Moher, D. (2013). SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine, 158(3), 200–207. https://doi.org/10.7326/0003-4819-158-3-201302050-00583

Cipriani, A., & Barbui, C. (2010). What is a clinical trial protocol?. Epidemiologia e psichiatria sociale, 19(2), 116–117. https://doi.org/10.1017/S1121189X00000804

Tetzlaff, J.M., Chan, AW., Kitchen, J. et al. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev 1, 43 (2012). https://doi.org/10.1186/2046-4053-1-43

University of California Los Angeles CTSI Research. Protocol Development (2017). https://www.researchgo.ucla.edu/protocol-development accessed 16 July 2021. 

Viergever, R. F., Karam, G., Reis, A., & Ghersi, D. (2014). The quality of registration of clinical trials: still a problem. PloS one, 9(1), e84727. https://doi.org/10.1371/journal.pone.0084727