metaData {clinDR}

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>

Examples

data('metaData')
names(metaData)