ABSTRACT

BACKGROUND

OBJECTIVES

RESEARCH DESIGN & METHODS

Objective: Trials in progress (TIP) abstracts for novel trial designs provide an opportunity to inform research community about ongoing clinical trials. Late-breaking abstracts (LBA) highlight innovative research findings and allow abstracts with no preliminary data available by submission deadline. We evaluated a 4-year trend of TIP and LBA presentations at major biomedical conferences.Research design and methods:Biomedical conferences for 10 therapeutic areas (TAs) were screened utilizing the Conference Authority database (Sylogent) as presented in Figure 1. Conference abstracts published between 2011 and 2014 (inclusive) were screened for TIP and LBA designations. Impact factors (IF) of journals that publish these abstracts were assessed.Results:Of total 75 conferences screened (4-year evaluation time period), across all TAs the TIP abstracts were permissible in few conferences (2011: n=4, 2014: n=7 conferences). Trend for LBAs increased from 27% (n=20/75) conferences in 2011 to 55% (n=41/75) conferences in 2014. Of more than 3500 LBAs accessed, 15-25% of clinical trial LBAs reported negative outcomes. Total 60% journals publishing TIP abstracts and 32% journals publishing LBAs, had an IF more than 10.Conclusions:Increasing trend for LBA presentations was observed across all TAs over the 4-year evaluation period while TIP abstracts were limited to few conferences. These abstracts were presented/published regardless of outcomes. Findings indicate a growing trend at biomedical conferences for rapid dissemination of novel information on emerging science and new agents.Key words: Abstracts, access, journals

• The Good publication practice (GPP2) guidelines emphasize sponsors’ responsibility to disseminate clinical trial results through presentations/publications in an effective and timely manner.1

• Trials in Progress abstracts provide an opportunity to inform medical community about ongoing novel clinical trials, newer agents and emerging science. These include ongoing clinical trials for which pre-specified endpoints have not been reached and no preliminary data is available.

• Late-Breaking abstracts highlight innovative research findings or provide latest breakthroughs in clinical science. These abstracts are permissible for research with no preliminary or conclusive data available by the general abstract submission deadline of conferences but become available soon thereafter.

• The Medical Publishing Insights and Practices (MPIP) recommendations for industry-sponsored clinical research propose that trial findings, including negative or unfavourable results be made available in a timely fashion.2

• To evaluate a 4-year trend of Trials in Progress and Late-Breaking abstracts presentations at major biomedical conferences

• To observe the impact factors and circulation of journals publishing these abstracts. Additionally, to assess transparency in reporting of these research findings.

• Biomedical conferences from 2011 to 2014 (inclusive) were screened utilizing Conference Authority database (Sylogent) for 10 therapeutic areas (TAs) (Figure 1).

• Conference proceedings and abstracts were analyzed to observe the trend of permissible Trials in Progress abstracts and Late-Breaking abstracts across the 10 TAs over the 4-year period.

• Impact factors (IF) of the journals that publish these abstracts were assessed.

• A thorough search was performed of each accessible, published Late-Breaking abstract to check if negative conclusions were reported in these abstracts. Presentation of results and conclusions is not permissible in Trial in Progress abstracts.

A total of 75 biomedical conferences were screened across 10 different TAs; 87% of these conferences had attendees ranging from 1,000 to 33,000.

• Fewer conferences were selected for the nephrology TA because most screened conferences were biennial/triennial or some were combined and organized in collaboration with other TAs.

Figure 3: Impact factor of journals publishing A) Trials in Progress and B) Late-Breaking abstracts

Figure 4: Transparency in reporting for Late-Breaking abstracts

A: Late-Breaking abstracts

A: Trials in Progress abstracts

B: Late-Breaking abstracts

Late-Breaking abstracts

B: Trials in Progress abstracts

RESULTS

• Over the 4-year evaluation period across all TAs, trend for Late-Breaking abstracts increased from 2011 (n=20/75, 27%) to 2014 (n=41/75, 55%), highest in cardiovascular diseases TA. The Trials in Progress abstracts were permissible in few conferences (2011: n=4, 2014: n=7 conferences); highest in oncology TA and none were observed in 4 TAs.

• The selection process was highly competitive for both Late-Breaking abstracts and Trials in Progress abstracts.

• Total 60% journals publishing Trials in Progress abstracts and 32% journals publishing Late-Breaking abstracts were high tier, with an impact factor >10.

• These abstracts of novel clinical trials had a wider reach to target audience as >80% of journals publishing these abstracts had a circulation greater than 2000, ranging from 2,500 to 31,000.

• Of the 3,605 published Late-Breaking abstracts accessed and analyzed 1,416 (39%) were for industry-sponsored clinical trials and across TAs, 15-25% (average: 18%) of these abstracts reported negative or unfavorable findings.

Figure 2: Biomedical conferences analyzed for A) Late-Breaking abstracts and B) Trials in Progress abstracts (2011 to 2014)

Figure 1: Number of conferences screened across different therapeutic areas

Rapid and transparent dissemination of novel clinical trials

Smart approaches to maximize timely dissemination of information on novel clinical trials:

Trials in Progress and Late-Breaking AbstractsMadhavi Patil,*a Namit Ghildyal,b and Vatsal Shaha

aSIRO Clinpharm Pvt. Ltd., Mumbai, India; bJanssen Research & Development, LLC., NJ, USA

*Presenting Author

23

Create awareness about new advances in clinical research to target audience (new drugs/ formulations with novel mechanism of action)

Facilitate patient enrolment for industry sponsors and investigators

Help achieve timelines as per publication plan

Avoid duplication of research- conserve resources (manpower, finance, time)

SUMMARY AND CONCLUSIONS

11th Annual Meeting of ISMPP, April 27-29, 2015, Arlington, VA, USA

References: 1. Chris Graf et al. Research Methods & Reporting. Good publication practice for communicating company sponsored medical

research: the GPP2 guidelines. BMJ 2009;339:b4330 2. Mansi BA et al. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint

journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87(5):424-9.Acknowledgements: The authors would like to thank the following colleagues from SIRO Clinpharm Pvt. Ltd.: Sujata Mahadik and Ramji Narayanan, for their contribution in data collection and collation and Sandeep Chavan for his creative support in the poster layout.Author contributions: All authors met ICMJE criteria, had access to study data and made the final decision about where to publish these data.

• An increasing trend was observed for Late-Breaking abstracts over the 4-year evaluation period (2011 to 2014). In contrast, Trials in Progress abstracts were limited to few conferences.

• A large number of these abstracts for innovative clinical trials were published in high tier journals (IFs >10): Trials in Progress abstracts: 60%, Late-Breaking Abstracts: 32%

• Over 80% of these journals had a wide reach to target audiences with circulation greater than 2000

• Across TAs, out of 3,605 published Late-Breaking abstracts, 15-25% of industry-sponsored clinical trial abstracts were presented/published regardless of outcomes indicating transparency in reporting clinical trials

Table 1: Circulation of journals publishing Trials in Progress and Late-Breaking abstracts <2000 >2,000 –

4,000>4,000 - <10,000

>10,000

Late-Breaking abstracts

19% 11% 37% 33%

Trials in Progress abstracts

20% 40% 0 40%

Implications• Our findings can likely create an increased awareness among industry sponsors and researchers to transparently share

innovative clinical trials information at conferences.

• Biomedical conferences for TAs with no or low permissible Late-Breaking and Trials in Progress abstracts could begin providing a forum for novel and substantive studies facilitating rapid dissemination of data on emerging science and newer agents.

All numbers are based only on the data accessible for the 75 conferences analyzed

CV: Cardiology and vascular, GE: Gastroenterology, Neuro: Neurology and Neurosciences

The contents of this poster represent the views of the authors and not necessarily the views of the companies which employ them.

Total: N=75

1

2

2

2

2

3

1

2

2

3

3

4

4

5

2

2

3

3

4

5

5

5

5

7

0 1 2 3 4 5 6 7 8

Nephrology

GE and hepatology

Transplantation

Rheumatology

Neurology and Neurosciences

Infectious diseases

Respiratory

Psychiatry

Oncology

CVM

2014

2013

2012

2011

0

0

0

0

1

1

1

1

1

2

0 1 2 3

Infectious diseases

Neurology and Neurosciences

Nephrology

Transplantation

Cardiology and vascular diseases

Rheumatology

Gastroenterology and hepatology

Psychiatry

Respiratory system

Oncology

2014

2013

2012

2011

Ther

apeu

tic a

rea

Ther

apeu

tic a

rea

No. of conferences

No. of conferences

60%

21%

47%

40%

32%