metaData: Dose response data from several published meta-analyses
In clinDR: Simulation and Analysis Tools for Clinical Dose Response Modeling

metaData

R Documentation

Dose response data from several published meta-analyses

Description

Dose response data from over 200 compounds included in published meta-analyses. The data are aggregated in a single data frame in a common format.

Usage

data('metaData')

Format

The data frame has one row for each compound, protocol within compound, and dose group within protocol. Compound and protocol level descriptors are repeated on each row of the data frame.

drugid: A numerical ID identifying each drug
taid: A drug can be studied in more than one therapeutic area. The taid ID identifies each TA/drug combination.
protid: Numerical (1,2,3,...) ID for protocols specific to each TAID.
gname: Generic drug name
bname: Branded(USA) drug name
drugtype: Drug classified as SMALL MOLECULE, BIOLOGIC, OTHER
route: Route of administration, e.g., oral, subcutaneous,...
routeShort: Abbreviated format for route
oralForm: Formulation (e.g., TABLET, POWDER,...) for drugs with oral administration.
fdaapproved: NA if status was not yet determined
metasource: Meta-analysis contributing compounds. BIO14: biological compounds through 2014; FDA914: FDA approved small molecules and 'other' 2009-2014; FDA1417: FDA approved compounds 2014-2017; Pfizer P2 compounds 1998-2009; PFIZERUPDATE18: Pfizer compounds 2009-2018
protno: Sponsor assigned protocol name/number
nctno: Clintrial.gov protocol ID
protyear: When available, year of first patient/first visit. In some cases, date of journal publication
design: PARELLEL, CROSSOVER,...
actcomp: Indicator if an active comparator was included in the protocol
etype: etype=1 for the designated primary endpoint. For completeness, where there was ambiguity in the selection of the endpoint, additional endpoint data was included on separate rows and indicated by etype=2,3,... Most analyses subset on etype=1
poptype: For a compound and TA, there can be distinctly different populations with anticipated response differences, e.g., treatment-naive and pre-treated patients. The population with the most studied doses has poptype=1. For completeness, additional populations are included and identified by poptype=2,3,.... Most analyses subset on poptype=1
primsource: IRO/PRO investigator/patient reported outcome; L lab, V vitals
primtype: Primary endpoint is BINARY, CONTINOUS, TIMETOEVEN
primtime: time units to primary endpoint from randomization
timeunit: DAY, HR, MIN, MONTH, WK for primary endpoint
indication: Disease description
broadta: Broad TA classification of the indication
endpointLong,endpointShort: Endpoint name and an abbreviated form using for example, cfb and pcfb for change from baseline and percent change from baseline
dose: Total daily dose for small molecules, total weekly dose for biologics in mg or mg/kg for weight-based dosing.
tload: Amount of any loading dose
nload: Number of visits with a loading dose
regimen: Dosing frequency
primregimen: primregimen=1 for most doses/regimens, but primregimen=2 for a few regimens that clearly differed from the most common regimen for the same total dose. Most analyses subset on primregimen=1
rslt: The sample dose group mean (continuous) or proportion (binary) of the primary endpoint. Analyses of the time-to-event endpoints was compound specific (either a mean or a proportion was estimated).
se: Standard error of rslt
sd: Dose group sample standard deviation for continuous data
lcl, ucl, alpha: alpha-level interval (lcl,ucl) when confidence intervals were extracted from the original data source because se were not reported
sampsize: Sample size reported for rslt. The handling of missing data by the protocol sponsors varied, but 'completers' was most common.
ittsize: The number randomized. The counts are usually available, except for internal data before 2009, where it was not collected.
pmiss: Percent of missing data.

Details

Compound sampling plans and other details are given in the publications:

Thomas, N., Sweeney, K., and Somayaji, V. (2014). Meta-analysis of clinical dose response in a large drug development portfolio, Statistics in Biopharmaceutical Research, Vol. 6, No.4, 302-317. <doi:10.1080/19466315.2014.924876>

Thomas, N., and Roy, D. (2016). Analysis of clinical dose-response in small-molecule drug development: 2009-2014. Statistics in Biopharmaceutical Research, Vol. 6, No.4, 302-317 <doi:10.1080/19466315.2016.1256229>

Wu, J., Banerjee, A., Jin, B. Menon, M. S., Martin, S. and Heatherington, A. (2017). Clinical dose response for a broad set of biological products: A model-based meta-analysis. Statistical Methods in Medical Research. <doi:10.1177/0962280216684528>