Abstract 3818
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.