Ethical and Scientific Implications of the Globalization of Clinical Research

The price of innovation: new estimates of drug development costs

DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003) · Journal of Health Economics · doi:10.1016/s0167-6296(02)00126-1 · Cited by 4,265 · see citing works

International Prevalence, Recognition, and Treatment of Cardiovascular Risk Factors in Outpatients With Atherothrombosis

Bhatt, D. L. (2006) · JAMA · doi:10.1001/jama.295.2.180 · Cited by 1,628 · see citing works

The Global Burden of Asthma

Braman, S. S. (2006) · CHEST Journal · doi:10.1378/chest.130.1_suppl.4s · Cited by 1,178 · see citing works

The Ethics of Clinical Research in the Third World

Angell, M. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371209 · Cited by 863 · see citing works

Coronary Intervention for Persistent Occlusion after Myocardial Infarction

Hochman, J. S., Lamas, G. A., Buller, C. E. H., Džavík, V., Reynolds, H. R., Abramsky, S., Forman, S. A., Rużyłło, W., Maggioni, A. P., White, H. D., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa066139 · Cited by 732 · see citing works

Trends in the globalization of clinical trials

Thiers, F. A., Sinskey, A. J., & Berndt, E. R. (2007) · Nature Reviews Drug Discovery · doi:10.1038/nrd2441 · Cited by 363 · see citing works

Pharmacogenetics goes genomic

Goldstein, D. B., Tate, S. K., & Sisodiya, S. M. (2003) · Nature Reviews Genetics · doi:10.1038/nrg1229 · Cited by 312 · see citing works

Sponsorship, Authorship, and Accountability

Davidoff, F. (2001) · New England Journal of Medicine · doi:10.1056/nejmed20010093 · Cited by 272 · see citing works

Rebuilding the R&D engine in big pharma.

Garnier, J.-P. (2008) · PubMed · Cited by 227 · see citing works

Ethical review of health research: a perspective from developing country researchers

Hyder, A. A., Wali, S., Khan, A. N., Teoh, N., KASS, N. E., & Dawson, L. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2002.001933 · Cited by 205 · see citing works

Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

Shapiro, H. T., & Meslin, E. M. (2001) · New England Journal of Medicine · doi:10.1056/nejm200107123450212 · Cited by 204 · see citing works

Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial.

Farkouh, M., Dangas, G., Leon, M., Smith, C. R., Nesto, R., Buse, J., Cohen, D., Mahoney, E., Sleeper, L., King, S., et al. (2008) · American Heart Journal · doi:10.1016/j.ahj.2007.10.012 · Cited by 198 · see citing works

A New Colonialism? — Conducting Clinical Trials in India

Nundy, S., & Gulhati, C. M. (2005) · New England Journal of Medicine · doi:10.1056/nejmp048361 · Cited by 185 · see citing works

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

Schulman, K., Seils, D. M., Timbie, J. W., Sugarman, J., Dame, L., Weinfurt, K., Mark, D., & Califf, R. (2002) · New England Journal of Medicine · doi:10.1056/nejmsa020349 · Cited by 176 · see citing works

Sensible approaches for reducing clinical trial costs

Eisenstein, E. L., Collins, R., Cracknell, B. S., Podesta, O., Reid, E. D., Sandercock, P. A., Shakhov, Y., Terrin, M. L., Sellers, M. A., Califf, R. M., et al. (2008) · Clinical Trials · doi:10.1177/1740774507087551 · Cited by 176 · see citing works

Specific barriers to the conduct of randomized trials

Duley, L., Antman, K. H., Arena, J. P., Avezum, Á., Blumenthal, M., Bosch, J., Chrolavicius, S., Li, T., Ôunpuu, S., Pérez, A. C., et al. (2008) · Clinical Trials · doi:10.1177/1740774507087704 · Cited by 173 · see citing works

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

Dilts, D. M., & Sandler, A. B. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2005.05.0104 · Cited by 166 · see citing works

Human rights and maternal-fetal HIV transmission prevention trials in Africa.

Annas, G. J., & Grodin, M. A. (1998) · American Journal of Public Health · doi:10.2105/ajph.88.4.560 · Cited by 144 · see citing works

Commercializing Clinical Trials — Risks and Benefits of the CRO Boom

Shuchman, M. (2007) · New England Journal of Medicine · doi:10.1056/nejmp078176 · Cited by 124 · see citing works

Structural and Functional Consequences of Coenzyme Binding to the Inactive Asian Variant of Mitochondrial Aldehyde Dehydrogenase

Larson, H. N., Zhou, J., Chen, Z., Stamler, J. S., Weiner, H., & Hurley, T. D. (2007) · Journal of Biological Chemistry · doi:10.1074/jbc.m607959200 · Cited by 111 · see citing works

Alcohol and Cancer

Seitz, H. K., Matsuzaki, S., Yokoyama, A., Homann, N., Vakevainen, S. M., & Wang, X. D. (2001) · Alcoholism Clinical and Experimental Research · doi:10.1111/j.1530-0277.2001.tb02388.x · Cited by 99 · see citing works

Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B

Dilts, D. M., Sandler, A. B., Baker, M., Cheng, S. K., George, S. L., Karas, K. S., McGuire, S., Menon, G. S., Reusch, J., Sawyer, D., et al. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2006.06.7819 · Cited by 79 · see citing works

An assessment of the quality of randomised controlled trials conducted in China

Zhang, D., Yin, P., Freemantle, N., Jordan, R., Zhong, N., & Cheng, K. (2008) · Trials · doi:10.1186/1745-6215-9-22 · Cited by 75 · see citing works

Ethical Oversight of Public Health Research: Can Rules and IRBs Make a Difference in Developing Countries?

London, L., & Health), (. (2002) · American Journal of Public Health · doi:10.2105/ajph.92.7.1079 · Cited by 70 · see citing works

Informed consent in Ghana: what do participants really understand?

Hill, Z. E., Tawiah‐Agyemang, C., Odei-Danso, S., & Kirkwood, B. R. (2007) · Journal of Medical Ethics · doi:10.1136/jme.2006.019059 · Cited by 67 · see citing works

Broadening the Debate

Osland, J. S. (2003) · Journal of Management Inquiry · doi:10.1177/1056492603012002005 · Cited by 59 · see citing works

Sensible guidelines for the conduct of large randomized trials

Yusuf, S., Bosch, J., Devereaux, P. J., et al. (2008) · Clinical Trials · doi:10.1177/1740774507088099 · Cited by 56 · see citing works

Institutions, Contracts, and Academic Freedom

Drazen, J. M. (2002) · New England Journal of Medicine · doi:10.1056/nejme020122 · Cited by 41 · see citing works

Ethics of clinical research in the developing world

Killen, J., Grady, C., Folkers, G. K., & Fauci, A. S. (2002) · Nature reviews. Immunology · doi:10.1038/nri745 · Cited by 39 · see citing works

Randomized clinical trials: Slow death by a thousand unnecessary policies?

Yusuf, S. (2004) · Canadian Medical Association Journal · doi:10.1503/cmaj.1040884 · Cited by 38 · see citing works

The Experience with Voluntary Genomic Data Submissions at the FDA and a Vision for the Future of the Voluntary Data Submission Program

Orr, M. S., Goodsaid, F. M., Amur, S., et al. (2007) · Clinical Pharmacology & Therapeutics · doi:10.1038/sj.clpt.6100053 · Cited by 37 · see citing works

Clinical Trials Seen Shifting Overseas

Rowland, C., & McMahon, J. (2004) · International Journal of Health Services · doi:10.2190/n8au-6ag6-30m9-fn6t · Cited by 34 · see citing works

Globalization of cardiovascular clinical research: The balance between meeting medical needs and maintaining scientific standards

Stough, W. G., Zannad, F. M., Pitt, B., et al. (2007) · American Heart Journal · doi:10.1016/j.ahj.2007.04.028 · Cited by 31 · see citing works

Indian regulations fail to monitor growing stem-cell use in clinics

Jayaraman, K. S. (2005) · Nature · doi:10.1038/434259a · Cited by 28 · see citing works

Simple Principles of Clinical Trials Remain Powerful

Califf, R. M. (2005) · JAMA · doi:10.1001/jama.293.4.489 · Cited by 28 · see citing works

Medical research in India

Srinivasan, S., & Loff, B. (2006) · The Lancet · doi:10.1016/s0140-6736(06)68861-2 · Cited by 20 · see citing works

Ethics of medical research in developing countries: the role of international codes of conduct

Hutton, J. L. (2000) · Statistical Methods in Medical Research · doi:10.1177/096228020000900302 · Cited by 17 · see citing works

Industry-sponsored research in developing countries.

Abbas, E. (2007) · Contemporary Clinical Trials · doi:10.1016/j.cct.2007.02.011 · Cited by 14 · see citing works

Drug companies cut costs with foreign clinical trials.

Rai, S. (2005) · PubMed · Cited by 14 · see citing works

From bench to bedside and back?

Gershon, D. (2001) · Nature · doi:10.1038/35108132 · Cited by 3 · see citing works

The ClinicalTrials.gov Results Database — Update and Key Issues

Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M., & Ide, N. C. (2011) · New England Journal of Medicine · doi:10.1056/nejmsa1012065 · Cited by 838 · see citing works

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

Califf, R. M. (2012) · JAMA · doi:10.1001/jama.2012.3424 · Cited by 516 · see citing works

Barriers for conducting clinical trials in developing countries—A systematic review

Alemayehu, C., Mitchell, G., & Nikles, J. (2018) · International Journal for Equity in Health · doi:10.1186/s12939-018-0748-6 · Cited by 406 · see citing works

Barriers to clinical research in Africa: a quantitative and qualitative survey of clinical researchers in 27 African countries

Conradie, A., Duys, R., Forget, P., & Biccard, B. M. (2018) · British Journal of Anaesthesia · doi:10.1016/j.bja.2018.06.013 · Cited by 129 · see citing works

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

Bentley, C., Cressman, S., van der Hoek, K., Arts, K., Dancey, J., & Peacock, S. (2019) · Clinical Trials · doi:10.1177/1740774518820060 · Cited by 104 · see citing works

Community engagement on the Thai-Burmese border: rationale, experience and lessons learnt.

Cheah, P. Y., Lwin, K. M., Phaiphun, L., Maelankiri, L., Parker, M., Day, N. P., White, N. J., & Nosten, F. (2010) · International Health · doi:10.1016/j.inhe.2010.02.001 · Cited by 80 · see citing works

Relationship Between Clinical Trial Site Enrollment With Participant Characteristics, Protocol Completion, and Outcomes

Butler, J., Subacius, H., Vaduganathan, M., Fonarow, G. C., Ambrosy, A. P., Konstam, M. A., Maggioni, A., Mentz, R. J., Swedberg, K., Zannad, F., et al. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.10.025 · Cited by 60 · see citing works

Barriers and Challenges to Global Clinical Cancer Research

Seruga, B., Sadikov, A., Cazap, E. L., Delgado, L. B., Digumarti, R., Leighl, N. B., Meshref, M. M., Minami, H., Robinson, E., Yamaguchi, N. H., et al. (2014) · The Oncologist · doi:10.1634/theoncologist.2013-0290 · Cited by 54 · see citing works

A call for clinical trial globalization in Alzheimer's disease and related dementia

Llibre‐Guerra, J. J., Heavener, A., Brucki, S. M. D., Marante, J. P. D., Pintado‐Caipa, M., Chen, Y., Behrens, M. I., Hardi, A., Admirall‐Sanchez, A., Akinyemi, R., et al. (2023) · Alzheimer's & Dementia · doi:10.1002/alz.12995 · Cited by 37 · see citing works

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Gudi, N., Kamath, P., Chakraborty, T., Jacob, A. G., Parsekar, S. S., Sarbadhikari, S. N., & John, O. (2022) · Journal of Medical Internet Research · doi:10.2196/33591 · Cited by 31 · see citing works

The opportunities and challenges in conducting clinical trials globally

Bansal, N. (2012) · Clinical Research and Regulatory Affairs · doi:10.3109/10601333.2011.647034 · Cited by 17 · see citing works

Safety and efficacy of prasugrel compared with clopidogrel in different regions of the world

Ruff, C. T., Giugliano, R. P., Antman, E. M., Murphy, S. A., Lotan, C., Heuer, H., Merkely, B., Baracioli, L., Schersten, F., Seabro-Gomes, R., et al. (2012) · International Journal of Cardiology · doi:10.1016/j.ijcard.2010.10.040 · Cited by 14 · see citing works

Are All Clinical Trial Sites Created Equal?

Bhatt, D. L., & Cavender, M. A. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.10.024 · Cited by 10 · see citing works

Getting involved in clinical trials research in the UK: how can Clinical Research Networks help?

Hull, M. A., Yiannakou, Y., Gower, J., et al. (2012) · Frontline Gastroenterology · doi:10.1136/flgastro-2011-100083 · Cited by 3 · see citing works

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators

Yanagawa, H., Nokihara, H., Yokoi, H., et al. (2018) · Journal of Clinical Medicine Research · doi:10.14740/jocmr3602w · Cited by 12 · see citing works

Clinical research units for the treatment of patients with HIV disease: operational issues and components needed to conduct clinical trials.

Godfrey, E., & Stanley, K. (1993) · PubMed · Cited by 3 · see citing works

The Effect of the Contribution of Clinical Research Coordinators in Clinical Trials at the Nagoya University Hospital.

Kamei, H., Tsuneko, K. A. T. O., Ando, S., et al. (2002) · Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics · doi:10.3999/jscpt.33.3_85 · Cited by 2 · see citing works

The Industrialization Of Clinical Research

Rettig, R. A. (2000) · Health Affairs · doi:10.1377/hlthaff.19.2.129 · Cited by 128 · see citing works