The Added Value of Clinical Data Nicole G Weiskopf, 8/21/18 - - PowerPoint PPT Presentation

the added value of clinical data
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The Added Value of Clinical Data Nicole G Weiskopf, 8/21/18 - - PowerPoint PPT Presentation

Clinical Data Wrangling Session 1: Introduction The Added Value of Clinical Data Nicole G Weiskopf, 8/21/18 Defjning Clinical Data Clinical documentation Unstructured: Progress notes, Medical Hx, etc Structured: Labs,


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Clinical Data Wrangling Session 1: Introduction

The Added Value of Clinical Data

Nicole G Weiskopf, 8/21/18

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Defjning “Clinical” Data

  • Clinical documentation

– Unstructured: Progress notes, Medical Hx, etc – Structured: Labs, Medications, Orders, Dx, etc

  • Administrative data (often included in

this defjnition)

– Billing – CMS, Insurance

  • Primary purpose is not research
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Benefjts of Clinical Data in Research

  • 1. Decrease costs (time and money)
  • 2. Enable recruitment and retention

– Underrepresented populations – Rare diseases

  • 3. Volume, variety, and velocity of data

https://www.gartner.com/it-glossary/big-data

  • 4. Increased representativeness (aka,

generalizability or external validity)

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Cost of traditjonal trials

Figure 2. Costs of clinical trials. Data are from 726 studies conducted in patjents from 2010-2015. Medians and means are indicated with diamonds and lines. Boxes indicate the 25th and 75th percentjles and whiskers indicate the 10th and 90th percentjles. Martjn L, Hutchens M, Hawkins C, Radnov A. How much do clinical trials cost? Nature Reviews Drug Discovery. 2017;16:381.

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Good research should give us broadly applicable truths

Thanks to Adam Wilcox Credit to Designing Clinical Research: An Epidemiologic Approach, Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB. Third editjon, 2006 Internal validity External validity

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Randomized controlled trials are the gold standard of clinical research…

Participants Population of Interest Eligible Randomization Randomization Intervention Intervention Control Control Control Intervention

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…but external validity may be limited

Weng C, et al. A Distribution-based Method for Assessing The Difgerences between Clinical Trial T arget Populations and Patient Populations in Electronic Health Records. ACI. 2014;5(2):463-479.

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…but external validity may be limited

Weng C, et al. A Distribution-based Method for Assessing The Difgerences between Clinical Trial T arget Populations and Patient Populations in Electronic Health Records. ACI. 2014;5(2):463-479.

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Lack of reprentativeness of clinical research can lead to healthcare disparities

Chen & Wong. 2018. Black Patjents Miss Out On Promising Cancer Drugs. ProPublica. htups://www.propublica.org/artjcle/black-patjents-miss-out-on-promising-cancer-drugs

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Lack of reprentativeness of clinical research can lead to healthcare disparities

Chen & Wong. 2018. Black Patjents Miss Out On Promising Cancer Drugs. ProPublica. htups://www.propublica.org/artjcle/black-patjents-miss-out-on-promising-cancer-drugs

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W

  • f EHR data and other sources of

clinical or administratjve data has the potentjal to enable more effjcient research with improved generalizability.