lifetime health status and health care.” 72 In turn, data analysts and researchers
can use such data to improve the delivery of care by looking at the
effectiveness and cost of specific interventions and treatments. 73 Such efforts
to refine payment and delivery systems are possible regardless of payer
source because all payers—private and public—share an interest in reducing
costs while ensuring access to care and quality services. 74
Additionally, policymakers, industry stakeholders, and researchers
continue to collaborate with respect to how sharing data across borders can
reduce costs in the drug approval process. 75 Data exchanges could reduce
costs and improve the efficiency of clinical trials occurring in different
countries. 76 If different countries harmonized formats for how clinical trials
must be conducted as well as how the resulting data must be submitted,
pharmaceutical companies might not need to conduct duplicative trials and
could submit data more quickly and easily to multiple regulators, thus
reducing the approval time for new drugs to come to market and into the
hands of patients. 77 The purported costs of running clinical trials has
increased so much that many pharmaceutical companies and foundational
sponsors are looking outside the United States and Europe to run these
trials. 78 Assembling clinical trial data from different countries can be
complex depending on each country’s rules for conducting a trial and
securing patients’ data as well as how sophisticated that country’s IT
infrastructure is. 79
Greater use and exchange of health data can enhance these harmonization
efforts and the drug development process. Data derived from EHRs can be
another means of collecting information to help supplement clinical trials:
72. Drabiak-Syed, supra note 40, at 40.
73. Sweet, supra note 4040, at 246; Roski, supra note 70, at 1115.
74. CANADA- U.S. HEALTH SUMMIT 2015, supra note 33, at 10.
75. Thomas Bollyky et al., Bridging the Gap: improving clinical development and the
regulatory pathways for health products for neglected diseases, 7 CLINICAL TRIALS 719, 721
(2010); see also Li, supra note 66, at 5 (“Clinical trial data transparency that ensures fair and
responsible access to data to enable further research and progress.”).
76. Sharona Hoffman & Andy Podgurski, The Use and Misuse of Biomedical Data: Is
Bigger Really Better? 39 AM. J. OF L. & MED. 497, 507–08 (2013) (“Observational studies are
often less costly and time-consuming than experimental research, especially when researchers
obtain the required data from existing databases.”); see Bollyky, supra note 75, at 721.
(“[N]ational and international requirements for data monitoring and record keeping have
increased in complexity. . . .[N]ow frequently comprise a third to two-thirds of total clinical
77. Betty Kuhnert, ICH at 20: An Overview, 3 GLOBAL FORUM 17, 17 (April 2011).
78. Li, supra note 66, at 1–2 (“[O]ne publication cited a $600M cost savings per year
(assuming 60,000 trial participants) through shifting 50 percent of late phase trials from the
U.S. and Europe to less costly locales such as India and South America.”).
79. Hoffman & Podgurski, supra note 76, at 506–07.