Epidemiology of recent Epidemiology of recent perinatal trials in Australiaperinatal trials in Australia

Philippa Middleton for the WOMBAT Collaboration Philippa Middleton for the WOMBAT Collaboration ((WomWomen and en and BBabies Wellbeing: abies Wellbeing: AAction through ction through

TTrials)rials)

PSANZ 2006PSANZ 2006

Aim of this studyAim of this study

To document perinatal trial activity in To document perinatal trial activity in AustraliaAustralia

To contribute to baseline measurements To contribute to baseline measurements for WOMBATfor WOMBAT

To highlight priority tasks for WOMBATTo highlight priority tasks for WOMBAT

MethodsMethods National and international trials registriesNational and international trials registries

Research grant databases (NHMRC)Research grant databases (NHMRC)

Selected the perinatal trials (generally Selected the perinatal trials (generally from 2000 on)from 2000 on)

Extracted data such as topic, funding, Extracted data such as topic, funding, number of recruitsnumber of recruits

100 perinatal trials100 perinatal trialsrecruiting or recently completed recruiting or recently completed

43 currently recruiting 43 currently recruiting (or not yet recruiting/in (or not yet recruiting/in development)development)

52 closed to accrual 52 closed to accrual publications located publications located

for 25for 25 1 trial stopped1 trial stopped

5 no details of status5 no details of status

Current status of trials

0

10

20

30

40

50

60

Recruiting

Closed

Stopped

No details

Trial topicTrial topic

Preterm Preterm (n=15)(n=15)

Respiratory Respiratory /lung/lung

PainPain Mode of birthMode of birth BreastfeedingBreastfeeding InfectionInfection

Trial topic (> 5 trials)

0

5

10

15

20

Type of interventionType of intervention

Drugs, Drugs, vitamins or vitamins or supplementssupplements

ProceduresProcedures Care/policyCare/policy

DevicesDevices EducationEducation

Types of intervention

0

10

20

30

40

MulticentreMulticentre

47 single centre47 single centre

48 multicentre48 multicentre 18 of these 18 of these

international international

5 no details5 no details

Type of Centre

0102030405060

Single Multi No details

Main centreMain centre

Victoria, NSW and SA 25% eachVictoria, NSW and SA 25% each

Remainder WA, Qld, international sites Remainder WA, Qld, international sites

Planned recruitment sizePlanned recruitment size > 2,000 > 2,000

recruits recruits (DOMINO, (DOMINO, Maternal Maternal posturing posturing trial)trial)

Median: Median: 100 to 500100 to 500

Recruitment size

0

10

20

30

40

50 > 2000

1000 - 1999

500 - 999

100 - 499

50 - 99

< 50

no details

Funding sourcesFunding sources

Information for 65/100 Information for 65/100 studiesstudies

35/65 (54%) funded 35/65 (54%) funded by NHMRCby NHMRC 25/35 (71%) solely 25/35 (71%) solely

NHMRCNHMRC

6 philanthropic6 philanthropic

7 professional bodies7 professional bodies

Funding sources

0

5

10

15

20

25

30

35

40

NHMRC

University

Hospital

Philanthropic

Industry

Professional bodies

Combinations (notNHMRC)

No details

No funding

Amount of funding Amount of funding

4/41 studies > 4/41 studies > $1 million$1 million

But mostly under But mostly under $500,000$500,000

Missing data for Missing data for > 50% studies > 50% studies

Amount of Funding

0

20

40

60

80 1,000,000 +

500,000 - 999,999

100,000 - 499,999

<100,000

Drugs only

No funding

No details

Time to publication Time to publication (from close of accrual)(from close of accrual)

25 of these 25 of these trials trials

published published since about since about

20002000

Typically 2 to Typically 2 to 3 years 3 years

from close from close of accrualof accrual

Time to publication

0

2

4

6

8

10

12

within 1 year

1 - 2 years

2 - 3 years

3 - 4 years

more than 4 years

Summary Summary and comments (1)and comments (1)

About 60 ‘active’ perinatal trials – 40 About 60 ‘active’ perinatal trials – 40 recruiting, 20 in follow-up/preparing recruiting, 20 in follow-up/preparing publicationpublication

About half the trials are multicentre (1/3 About half the trials are multicentre (1/3 international (n=18))international (n=18))

Is median 100 to 500 large enough?Is median 100 to 500 large enough?

Summary Summary and comments (2)and comments (2)

Missing information – ACTR will assistMissing information – ACTR will assist

NHMRC funds half the trialsNHMRC funds half the trials

Most $0.5 million or lessMost $0.5 million or less

Potential for other funding sources?Potential for other funding sources?

Potential for more multicentre/international Potential for more multicentre/international trials?trials?