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‘Research’ vs ‘real world’ patients: the representativeness of clinical trial participants

Date

10 Oct 2016

Session

Poster display

Presenters

Yasemin Karanis

Citation

Annals of Oncology (2016) 27 (6): 526-544. 10.1093/annonc/mdw392

Authors

Y.B. Karanis1, F.A. Bermudez Canta1, L. Mitrofan2, H. Mistry1, C. Anger1

Author affiliations

  • 1 Global Oncology, IMS Health, N1 9JY - London/GB
  • 2 Global Oncology, IMS Health, 92088 - La Defence/FR
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Background

Randomized Clinical Trials (RCTs) are the gold standard in assessing the efficacy of new treatments as they allow for the analysis of a homogenous study population. However restricting the eligibility criteria may result in cherry-picking RCT participant thus compromising the generalisability. We have investigated differences in certain prognostic factors between trial and non-trial patients to see if this has an effect on how long patients stay on cytotoxic or targeted treatments.

Methods

IMS Health Oncology Analyzer™, a patient database collected through a quarterly physician panel survey was used. Data includes Stage IV, NSCLC, Colorectal (CRC) and Pancreatic Cancer (PC) patients within EU5 (France, Germany, Italy, Spain, UK) reported between 2013 and 2015. For the initial analysis the prognostic factors compared are ECOG, Co-morbidities and Age. For the secondary analysis cytotoxic and targeted treatments were grouped and the average duration of treatments (DOTs) were compared.

Results

Based on the results displayed above, patients enrolled in clinical trials are more likely to be Younger (1), Fitter (2) and with No-Comorbidities (3) versus ‘Real World’ patients. Similar DOTs (4) were observed for the two patient groups in CRC and NSCLC. Sample number for PC patients with DOT information were too low to analyse.

NSCLC CRC PC
Non-Trial n = 10,534 Trial n = 439 Non-Trial n = 6,260 Trial n = 265 Non-Trial n = 4,081 Trial n = 41
(1) Age
65 Years of age 46% 39% 54% 45% 55% 39%
(2) Performance Status
ECOG 0-1 78% 85% 84% 89% 66% 71%
ECOG 2-4 22% 15% 16% 11% 34% 29%
(3) Co-Morbidities
No Co-morbidities 40% 55% 49% 64% 39% 66%
4) Average DOT (months)
Cytotoxic Treatments 3.7 3.8 6.3 6.4 4.8 -
Targeted Treatments 7.6 7.3 7.6 7.2 6.4 -

Conclusions

Our data supports the existence of prognostic differences between ‘Trial’ and ‘Real World’ patients. Even though we have not observed an effect of this on DOT, further analysis is required to study the array of clinical and survival outcomes that prognostic differences are likely to impact. The next step is a comparison of parameters such as response to therapy, adverse events and Progression Free Survival to further analyse the representativeness of RCTs.

Clinical trial identification

Legal entity responsible for the study

IMS Health

Funding

IMS Health

Disclosure

All authors have declared no conflicts of interest.

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