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PUBLICATION SPOTLIGHT
Achieving an Intelligent HealthScience System: Aligning science, health, business, policy and technology for patients and society
This report captures our proposal for achieving an IIHS and a proposal for continuation of the SYNERGY fora to further advance needed change and a design process.
We advocate creation of a platform and an engine focussing on People, Processes, Policy, and Technology to design and realize this vision through an effective hard and soft systems approach.
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The Future of Health and Science: Envisioning an Intelligent HealthScience System
"At present, promising work is being done in developing the Learning Health Systems (LHS) ... Expanding and more rigorously applying systems-thinking and systems engineering principles to the conceptual underpinnings of a LHS, one can envision a future state that can be characterized as a comprehensive Intelligent HealthScience System ..." Read >>
Kohn, M.S., Kush, R., Whalen, M. et al. The Future of Health and Science: Envisioning an Intelligent HealthScience System. Pharm Med 37, 1–6 (2023). https://doi.org/10.1007/s40290-022-00455-7
Accreditation of Research Sites – Moving Forward
"An initiative to design a system of accreditation that would improve and ensure the quality, performance, and safety of clinical trial sites is now coming to fruition...." Read >>
Koski, G., Kennedy, L., Tobin, M. F., & Whalen, M. (2018). Accreditation of clinical research sites — Moving forward. New England Journal of Medicine, 379(5), 405–407. https://doi.org/10.1056/NEJMp1806934
A Systems Approach to Enhance Clinical Research and Medicines Development
"The biopharmaceutical industry has traditionally been the key link between basic biomedical discovery and novel medicines. Today, the industry faces numerous challenges including the broad agreement that the current clinical trial system is inefficient and flawed..." Read >>
Silva, H., Koski, G., Whalen, M., Tobin, M., Widler, B., Pacino, A. O. II, & Edwards, B. (2016). A systems approach to enhance clinical research and medicines development. Journal of Medicines Development Sciences, 1(1). https://doi.org/10.18063/jmds.v1i1.111Select Publications
A Global Clinical Research Network: Moving Beyond Harmonization
Koski, G., Widler, B., & Olmsted, A. (2011). A global clinical research network: Moving beyond harmonization. Regulatory Affairs Pharma, July.
The shared ethical responsibility of medically and non-medically qualified experts in human drug development teams
Kerpel-Fronius, S., Becker, S., Barrett, J., Brun, J., Carlesi, R., Chan, A., Collia, L. F., Dubois, D. J., Kleist, P., Koski, G., Kurihara, C., Laranjeira, L. F., Schenk, J., & Silva, H. (2018). The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams. Frontiers in pharmacology, 9, 843. https://doi.org/10.3389/fphar.2018.00843
The Future of Health and Science: Envisioning an Intelligent HealthScience System
Kohn, M. S., Kush, R., Whalen, M., Tobin, M., Dori, D., & Koski, G. (2022). The Future of Health and Science: Envisioning an Intelligent HealthScience System. Pharmaceutical Medicine, 37(1), 1–6. https://doi.org/10.1007/s40290-022-00455-7
Overcoming Inefficiencies in Clinical Research by Fostering a Systems Approach and Core Competencies for Biomedical Professionals Involved in Medicines Development
Silva, H., Kennedy, L., Koski, G., Sonstein, S., & Stonier, P. (2020). Overcoming inefficiencies in clinical research by fostering a systems approach and core competencies for biomedical professionals involved in medicines development. Gac Méd Caracas, 128(4), 607–618. https://doi.org/10.47307/GMC.2020.128.4.15
Vulnerability and Clinical Research
Mermet-Bouvier, P., & Whalen, M. D. (2020). Vulnerability and clinical research: Mapping the challenges for stakeholders. Therapeutic Innovation & Regulatory Science, 54(5), 1037–1046. https://doi.org/10.1007/s43441-020-00121-7
The Shared Ethical Responsibility of Medically and Non-Medically Qualified Experts in Human Drug Development Teams
Kerpel-Fronius, S., Becker, S., Barrett, J., Brun, J., Carlesi, R., Chan, A., Collia, L. F., Dubois, D. J., Kleist, P., Koski, G., Kurihara, C., Laranjeira, L. F., Schenk, J., & Silva, H. (2018). The shared ethical responsibility of medically and non-medically qualified experts in human drug development teams. Frontiers in Pharmacology, 9, 843. https://doi.org/10.3389/fphar.2018.00843
A Call to Incorporate Systems Theory and Human Factors into the Existing Investigation of Harm in Clinical Research Involving Healthcare Products
Edwards, B. D., Bégaud, B., Daemen, E., Dokas, I., Fishbein, J. M., Greenberg, H. E., Hochberg, A., Le Louet, H., Lyngvig, J., Mogles, N., Owen, K., Prendergast, C., Rejzek, M., Trantza, S., Webb, D. J., Whalen, M., & Whiteley, S. (2017). A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products. British Journal of Clinical Pharmacology, 83(11), 2339–2342. https://doi.org/10.1111/bcp.13353
Endpoint Adjudication of Events Charter Template: What Should Be Included?
Widler, B., Garibbo, M., France, K., Gichuru, M., & Bonilla, L. (2016). Endpoint adjudication of events charter template: What should be included? Applied Clinical Trials, December 13. https://www.appliedclinicaltrialsonline.com/view/endpoint-adjudication-events-charter-template-what-should-be-included
Fostering Competence in Medicines Development: The IFAPP Perspective
Dubois, D. J., Jurczynska, A., Kerpel-Fronius, S., Kesselring, G., Imamura, K., Nell, G., Silva, H., & Stonier, P. (2016). Fostering competence in medicines development: The IFAPP perspective. Frontiers in Pharmacology, 7, 377. https://doi.org/10.3389/fphar.2016.00377
The Future of Pharmacovigilance: Proposals for More Efficient and Effective Systems-Based Approaches
Furlan, G., Edwards, B., Mastroianni, A., & Koski, G. (2016). The future of pharmacovigilance: Proposals for more efficient and effective systems-based approaches. Pharmaceutical Medicine, 30(3), 137–142. https://doi.org/10.1007/s40290-016-0145-7
Can Pharmacovigilance Learn From the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century?
van Leeuwen, B. P., Prendergast, C., Edwards, B., & Dawson, B. (2017). Can pharmacovigilance learn from the oil and gas industry, which has been outsourcing for over a century? Therapeutic Innovation & Regulatory Science, 51(1), 11–15. https://doi.org/10.1177/2168479016659518
Aiming High
Bajpai, A., Koski, G., & Tobin, M. (2015). Aiming high. International Clinical Trials. http://www.samedanltd.com/magazine/13/issue/238/article/4149
Clinical Trials: Beyond Efficiency – Why Are We Flying Blind?
Koski, G., & Whalen, M. (2015). Clinical trials: Beyond efficiency – Why are we flying blind? Clinical Investigation (London), 5(3), 235–238.
From Silos to Bridges in Clinical Research
Whalen, M., & Goebel, P. (2010). From silos to bridges in clinical research. The Monitor, 24(5), 41–45.
Rx for Industry: REMS and Safety as Paradigm
Olsen, A., & Whalen, M. (2010). Rx for industry: REMS and safety as paradigm. Drug Discovery, 15(3), 22–27.
Public Perceptions of the Pharmaceutical Industry and Drug Safety
Olsen, A. K., & Whalen, M. D. (2009). Public perceptions of the pharmaceutical industry and drug safety: Implications for the pharmacovigilance professional and the culture of safety. Drug Safety, 32(10), 805–810. https://doi.org/10.2165/11316620-000000000-00000
Ethical Issues in Translational Research and Clinical Investigation
Koski, G. (2009). Ethical issues in translational research and clinical investigation. In D. Robertson & G. H. Williams (Eds.), Clinical and Translational Science: Principles of Human Research (Ch. 24). Elsevier.
GCP Challenges for 2008 and Beyond
Whalen, M., Edwards, B., & Mather, J. (2008). GCP challenges for 2008 and beyond. Journal of GxP Compliance.
Guiding Principles of Safety as a Basis for Developing a Pharmaceutical Safety Culture
Edwards, B., Olsen, A., Whalen, M., & Gold, M. (2007). Guiding principles of safety as a basis for developing a pharmaceutical safety culture. Current Drug Safety, 2(2), 135–139. https://doi.org/10.2174/157488607780598331
Recruitment of Research Subjects
Whalen, M., & Khin-Maung-Gyi, F. (2006). Recruitment of research subjects. In R. Amdur et al. (Eds.), Institutional Review Board: Management and Function (2nd ed.). Jones & Bartlett.
Accreditation of Human Research Protections Programs: A Validation Approach for GCPs?
Speers, M., & Whalen, M. (2005). Accreditation of human research protections programs: A validation approach for GCPs? Journal of GxP Compliance.
Getting Past Protectionism: Is It Time to Take Off the Training Wheels?
Koski, G. (2014). Getting past protectionism: Is it time to take off the training wheels? In G. E. P. Kahn (Ed.), Human Subjects Research Regulation: Perspectives on the Future (Ch. 22). MIT Press. https://doi.org/10.7551/mitpress/9830.003.0035
The Synergy of the Whole: Building a Global System for Clinical Trials to Accelerate Medicines Development
Koski, G., Tobin, M. F., & Whalen, M. (2014). The synergy of the whole: Building a global system for clinical trials to accelerate medicines development. Clinical Therapeutics, 36(10), 1356–1370. https://doi.org/10.1016/j.clinthera.2014.09.006
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