TY - JOUR
T1 - Real World Data in Adaptive Biomedical Innovation
T2 - A Framework for Generating Evidence Fit for Decision-Making
AU - Schneeweiss, S
AU - Eichler, H-G
AU - Garcia-Altes, A
AU - Chinn, C
AU - Eggimann, A-V
AU - Garner, S
AU - Goettsch, W
AU - Lim, R
AU - Löbker, W
AU - Martin, D
AU - Müller, T
AU - Park, B J
AU - Platt, R
AU - Priddy, S
AU - Ruhl, M
AU - Spooner, A
AU - Vannieuwenhuyse, B
AU - Willke, R J
N1 - © 2016 American Society for Clinical Pharmacology and Therapeutics.
PY - 2016/12
Y1 - 2016/12
N2 - Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.
AB - Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.
KW - Biomedical Research/organization & administration
KW - Databases, Factual/statistics & numerical data
KW - Decision Making
KW - Delivery of Health Care/organization & administration
KW - Diffusion of Innovation
KW - Efficiency, Organizational
KW - Electronic Health Records
KW - Health Services Accessibility
KW - Humans
KW - Technology Assessment, Biomedical
U2 - 10.1002/cpt.512
DO - 10.1002/cpt.512
M3 - Article
C2 - 27627027
SN - 0009-9236
VL - 100
SP - 633
EP - 646
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 6
ER -