PMID- 33301138
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20210624
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 54
IP  - 3
DP  - 2020 May
TI  - Impact of FDA-Required Cardiovascular Outcome Trials on Type 2 Diabetes Clinical 
      Study Initiation From 2008 to 2017.
PG  - 640-644
LID - 10.1007/s43441-019-00098-y [doi]
AB  - BACKGROUND: Since 2008, the US Food and Drug Administration (FDA) has required 
      that drug manufacturers conduct postmarket cardiovascular outcomes trials (CVOTs) 
      for approved type 2 diabetes mellitus (T2DM) drugs. The utility and impact of 
      these studies in determining atherosclerotic cardiovascular risk was reviewed 
      during an FDA Advisory Committee Meeting held on October 24, 2018. Drug 
      manufacturers and patient advocates at this meeting contended that the 
      FDA-required CVOT studies discouraged private sector investment into developing 
      novel T2DM drugs. Here, we explore these contentions by reviewing private sector 
      investment in T2DM drug development from 2000 through 2008, followed by a 
      deductive analysis of how associated events-including the implementation of the 
      CVOT requirement-may have precipitated any observed changes. METHODS: We 
      collected and analyzed industry-sponsored interventional trials for T2DM 
      initiated between January 1, 2000, and December 31, 2017, and compared observed 
      trends with those seen across all trials, specific diseases, and against patent 
      filings of novel antidiabetic agents. RESULTS: The analysis shows a marked 
      decline in initiated T2DM clinical trials from 2008 through 2017. Possible 
      influencing factors, including the 2008 financial crisis and a slow in the 
      discovery of novel antidiabetic agents may have contributed, but could not fully 
      account for this decline in T2DM studies. CONCLUSIONS: These observations are 
      consistent with the statements made by industry representatives and patient 
      advocates at the 2018 Advisory Committee meeting. As the FDA reconsiders 
      postmarket requirements for T2DM products, these observations underscore the 
      importance of considering more efficient postmarket study structures to assess 
      cardiovascular safety beyond mandatory CVOTs.
FAU - Kieffer, Cameron M
AU  - Kieffer CM
AUID- ORCID: 0000-0001-7509-7503
AD  - Global Regulatory Science and Policy-NA, 4520 East West Highway, Suite 210, 
      Sanofi, Bethesda, MD, 20814, USA.
FAU - Robertson, Andrew S
AU  - Robertson AS
AUID- ORCID: 0000-0003-2568-5379
AD  - Global Regulatory Science and Policy-NA, 4520 East West Highway, Suite 210, 
      Sanofi, Bethesda, MD, 20814, USA. Andrew.robertson@sanofi.com.
LA  - eng
PT  - Journal Article
DEP - 20200106
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - *Cardiovascular System
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Humans
MH  - Hypoglycemic Agents
MH  - Research Design
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - cardiovascular outcomes trials
OT  - data-driven
OT  - drug development
OT  - postmarketing
OT  - regulatory science
EDAT- 2020/12/11 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/12/10 12:18
PHST- 2019/04/22 00:00 [received]
PHST- 2019/06/06 00:00 [accepted]
PHST- 2020/12/10 12:18 [entrez]
PHST- 2020/12/11 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
AID - 10.1007/s43441-019-00098-y [pii]
AID - 10.1007/s43441-019-00098-y [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2020 May;54(3):640-644. doi: 10.1007/s43441-019-00098-y. 
      Epub 2020 Jan 6.