Metastatic gastroesophageal cancer in older patients – is this patient cohort represented in clinical trials?

Abstract Background Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years, focusing on patients with metastatic gastroesophageal cancer. Methods A search strategy was developed encompassing Embase, PubMed and The Cochrane Library databases. Completed phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies from 1st January 1995 to 18th November 2020 were identified. These were screened for eligibility using reference management software (Covidence; Veritas Health Innovation Ltd). Data including age inclusion/exclusion criteria and median age of participants were recorded. The percentage of patients ≥ 65 enrolled was collected where available. The change over time in the proportion of studies using an upper age exclusion was estimated using a linear probability model. Results Three hundred sixty-three phase III studies were identified and screened, with 66 trials remaining for final analysis. The majority of trials were Asian (48%; n = 32) and predominantly evaluated gastric malignancies, (86%; n = 56). The median age of participants was 62 (range 18–94). Thirty-two percent (n = 21) of studies specified an upper age limit for inclusion and over half of these were Asian studies. The median age of exclusion was 75 (range 65–80). All studies prior to 2003 used an upper age exclusion (n = 12); whereas only 9 that started in 2003 or later did (17%). Among later studies, there was a very modest downward yearly-trend in the proportion of studies using an upper age exclusion (-0.02 per year; 95%CI -0.05 to 0.01; p = 0.31). Fifty-two percent (n = 34) of studies specified the proportion of their study population who were ≥ 65 years. Older patients represented only 36% of the trial populations in these studies (range 7–60%). Conclusions Recent years have seen improvements in clinical trial protocols, with many no longer specifying restrictive age criteria. Reasons for poor representation of older patients are complex and ongoing efforts are needed to broaden eligibility criteria and prioritise the inclusion of older adults in clinical trials.

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Metastatic Gastroesophageal Cancer in Older Patients – Is this Patient Cohort Represented in Clinical Trials?

10.21203/rs.3.rs-684646/v1 ◽

2021 ◽

Author(s):

Maeve A. Hennessy ◽

Munzir Hamid ◽

Niamh Keegan ◽

Lynda Corrigan ◽

Caitriona Goggin ◽

...

Keyword(s):

Clinical Trials ◽

Older Patients ◽

Probability Model ◽

Phase Iii ◽

Standards Of Care ◽

Cochrane Library ◽

Gastroesophageal Cancer ◽

Eligibility Criteria ◽

Oncological Treatment ◽

Linear Probability

Abstract Background: Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years, focusing on patients with metastatic gastroesophageal cancer. Methods: A search strategy was developed encompassing Embase, PubMed and The Cochrane Library databases. Completed phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies from1st January 1995 to 18th November 2020 were identified. These werescreened for eligibility using reference management software (Covidence; Veritas Health Innovation Ltd). Data including age inclusion/exclusion criteria and median age of participants were recorded. The percentage of patients≥65 enrolled was collected where available.The change over time in the proportion of studies using an upper age exclusion was estimated using a linear probability model.Results: 363 phase III studies were identified and screened, with 66 trials remaining for final analysis. The majority of trials were Asian (48%; n = 32) and predominantly evaluated gastric malignancies, (86%; n = 56).The median age of participants was 62 (range 18-94). Thirty-two percent (n = 21) of studies specified an upper age limit for inclusion and over half of these were Asian studies. The median age of exclusion was 75 (range 65-80). All studies prior to 2003 used an upper age exclusion (n = 12); whereas only 9 that started in 2003 or later did (17%). Among later studies, there was a very modest downward yearly-trend in the proportion of studies using an upper age exclusion (-0.02 per year; 95%CI -0.05 to 0.01; p = 0.31). Fifty-two percent (n = 34) of studies specified the proportion of their study population who were ≥65 years. Older patients represented only 36% of the trial populations in these studies (range 7-60%).Conclusions: Recent years have seen improvements in clinical trial protocols, with many no longer specifying restrictive age criteria. Reasons for poor representation of older patients are complex and ongoing efforts are needed to broaden eligibility criteria and prioritise the inclusion of older adults in clinical trials.

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Participation of older patients with advanced gastroesophageal cancer in clinical trials: A systematic review of age-restrictive inclusion criteria over the last 25 years.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e24017 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e24017-e24017

Author(s):

Maeve Hennessy ◽

Munzir Hamid ◽

Caitriona Goggin ◽

Myo Oo Nay ◽

Marie Carrigan ◽

...

Keyword(s):

Clinical Trials ◽

Older Patients ◽

Phase Iii ◽

Cochrane Library ◽

Gastroesophageal Cancer ◽

Inclusion Criteria ◽

Asian Studies ◽

Trial Protocols ◽

Age Limit ◽

Linear Probability

e24017 Background: Cancer is a disease of aging, however older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years. We focused on patients with metastatic gastroesophageal cancer. Methods: A search strategy was developed encompassing Embase, Pubmed and The Cochrane Library databases. All completed Phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies for the period 01.01.95 to 18.11.20 were identified. Reference management software (Covidence; Veritas Health Innovation Ltd) was used to screen for inclusion/exclusion. The following details were extracted from trial protocols: country of study, date of publication, patient number, age inclusion and exclusion criteria. The median age of participants and the percentage of older patients enrolled in each study was collected. A linear probability model was used to estimate the change over time in the proportion of studies using an upper age exclusion. Results: 363 phase III studies were identified. 152 studies were eligible for full text review, 86 were excluded, leaving 66 trials for final analysis. 86% (n = 56) included Gastric, 9% (n = 6) Oesophageal and 5% (n = 3) Oesophagogastric malignancies. Asian studies represented 48% (n = 32) of trials, 29% (n = 19) were worldwide and 23% (n = 15) were European. The median age of trial participants was 62, (range 18-94). No clear trend in the ages of study participants over the time period was identified. 32% (n = 21) of studies specified an upper age limit for inclusion and 57% of these were Asian studies. The median age of exclusion was 75 years (range 65-80). All studies starting before 2003 used an upper age exclusion (n = 12); whereas only 9 of the 52 that started in 2003 or later did (17%). Among these later studies, there was a very modest downward yearly-trend in the proportion of studies using an upper age exclusion (-0.02 per year; 95%CI -0.05 to 0.01; p = 0.31). 52% (n = 34) of studies specified the proportion of their study population who were over 65 years. Older patients represented only 36% of the trial populations in these studies (range 7-60%). Our search of currently enrolling trials on clinicaltrials.gov yielded 11 active studies, none of which specified an upper age limit. Conclusions: Recent years have seen improvements in clinical trial protocols, with many no longer specifying restrictive age criteria. Reasons for poor representation of older patients are complex and ongoing efforts are needed to broaden eligibility criteria and prioritise the inclusion of older adults in clinical trials.

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Optimising Chemotherapy for Frail and Older Patients With Advanced Gastroesophageal Cancer: The GO2 Phase III Trial

SSRN Electronic Journal ◽

10.2139/ssrn.3724274 ◽

2020 ◽

Author(s):

Peter Hall ◽

Daniel Swinson ◽

David A. Cairns ◽

Justin Waters ◽

Russell Petty ◽

...

Keyword(s):

Older Patients ◽

Phase Iii ◽

Gastroesophageal Cancer ◽

Phase Iii Trial

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Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis

Annals of Pharmacotherapy ◽

10.1177/1060028019885836 ◽

2019 ◽

Vol 54 (4) ◽

pp. 380-387 ◽

Cited By ~ 3

Author(s):

Wendy Li ◽

Rima Ghamrawi ◽

Wasim Haidari ◽

Steven R. Feldman

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Plaque Psoriasis ◽

Data Extraction ◽

Severity Index ◽

Phase Iii ◽

Cochrane Library ◽

Severe Plaque Psoriasis ◽

Phase Iii Clinical Trials ◽

Interleukin 23

Objective: Risankizumab (Skyrizi), an interleukin-23 (IL-23) antagonist, was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in April 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this drug. Data Sources: A systematic literature review was performed using the terms “psoriasis AND risankizumab” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles written in English between January 2000 and October 2019 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary end point at week 16 in phase III trials, more patients achieved Psoriasis Area and Severity Index 90 receiving 150 mg risankizumab (72%-75%) compared with placebo (2.0%-4.9%, P < 0.001), 45 or 90 mg ustekinumab (42.0%-48%, P < 0.0001), and 40 mg adalimumab (47%, P < 0.0001). More patients achieved a static Physician’s Global Assessment score of 0 or 1 receiving 150 mg risankizumab (84%-88%) compared with placebo (5.1%-7.8%, P < 0.001), 45 or 90 mg ustekinumab (62%-63%, P < 0.0001), and 40 mg adalimumab (60%, P < 0.0001). Risankizumab was well tolerated across all studies. Conclusion: Risankizumab is a newly FDA-approved IL-23 inhibitor that shows particular promise in the treatment of plaque psoriasis. Based on this review, it is an effective and safe addition to the armamentarium of biologics that are currently available.

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Reducing patient eligibility criteria in cancer clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.4.1364 ◽

1996 ◽

Vol 14 (4) ◽

pp. 1364-1370 ◽

Cited By ~ 89

Author(s):

S L George

Keyword(s):

Clinical Trials ◽

Sample Size ◽

Acute Lymphocytic Leukemia ◽

Lymphocytic Leukemia ◽

Phase Iii ◽

Eligibility Criterion ◽

Cancer Clinical Trials ◽

Recent Trial ◽

Eligibility Criteria ◽

Eligibility Requirements

PURPOSE To discuss patient eligibility criteria in phase III cancer clinical trials in the larger setting of the complexity of these trials, to review the various reasons for imposing restrictive eligibility requirements, to discuss the problems caused by these requirements, to argue that these requirements should be greatly relaxed in most cancer clinical trials, to provide some guiding principles and practical suggestions to facilitate such a relaxation, and to give an example of how eligibility requirements were reduced in a recent clinical trial in acute lymphocytic leukemia. METHODS Implicit and explicit reasons for including eligibility criteria in clinical trials are reviewed. Safety concerns and sample size issues receive special attention. The types of problems restrictive eligibility criteria cause with respect to scientific interpretation, medical applicability, complexity, costs, and patient accrual are described. RESULTS A list of three items that each eligibility criterion should meet in order to be included is proposed and applied to a recent trial in acute lymphocytic leukemia. CONCLUSION Phase III clinical trials in cancer should have much broader eligibility criteria than the traditionally restrictive criteria commonly used. Adoption of less restrictive eligibility criteria for most studies would allow broader generalizations, better mimic medical practice, reduce complexity and costs, and permit more rapid accrual without compromising patient safety or requiring major increases in sample size.

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Recruitment of Infants with Sickle Cell Anemia to a Phase III Trial:Data from the BABY HUG Study.

Blood ◽

10.1182/blood.v112.11.1429.1429 ◽

2008 ◽

Vol 112 (11) ◽

pp. 1429-1429 ◽

Cited By ~ 3

Author(s):

Lynn W Wynn ◽

Lane Faughnan ◽

Daner Li ◽

Winfred Wang ◽

Brenda Martin ◽

...

Keyword(s):

Decision Making ◽

Clinical Trials ◽

Clinical Care ◽

Phase Iii ◽

Screening Tests ◽

Investigational Drug ◽

Eligibility Criteria ◽

Double Blind ◽

Screening Process ◽

Factors Influencing

Abstract Background: Factors influencing participation in clinical trials have been reported, but few studies analyze the combination of issues which affect overall patient accrual. When designing clinical trials, investigators are aware that some potential subjects may not be candidates for research participation and other subjects will decline. Total sample size is further affected by protocol-defined eligibility. BABY HUG (NCT00006400) is a randomized, double-blind, placebo-controlled Phase III clinical trial of hydroxyurea (HU), which had an enrollment goal of 200 infants, age 9–17 mo, with Hb SS or Sβ0-thalassemia. A number of screening tests (spleen scan, 99mTc-DTPA renal clearance, abdominal sonogram, transcranial Doppler ultrasound, neuropsychological testing, blood analyses) were required prior to study entry and at exit, with at least monthly follow-up visits during the 2-year study period. To enhance recruitment, an anonymized registry of potential subjects was created to identify factors affecting enrollment. Methods: BABY HUG study coordinators considered all infants with an FS/SS diagnosis on newborn screening who were less than age 17 mo. The coordinators developed an IRB-approved spreadsheet to record the number of potentially eligible subjects; whether parents were approached and, if not, why not; and reasons of those approached for participating or declining. Most of these reasons could be categorized into one of several common themes. Results: Of 1107 potential participants (23–132/center) identified between October 2003 and June 2007, 239 (22%) entered the screening process and 193 (17%) were randomized. More than 25% were not approached for various reasons, including poor adherence to standard clinical care or failing to meet eligibility criteria. Factors influencing enrollment decisions are shown in the figure. The willingness to contribute to medical knowledge, the hope of being randomized to receive the investigational drug (HU), and the desire for closer clinical care were the most common reasons for participating in BABY HUG. Conversely, fear of research, transportation problems, parental work schedules and the demanding nature of the study (with frequent blood samples and clinic visits) were the primary reasons for parents declining. Disease severity had less impact on decision-making, perhaps reflecting the often asymptomatic history of potential subjects. Conclusion: The time and effort required by multiple screening tests and frequent visits impact the willingness of eligible subjects to participate in a study. Similar trials may require a larger pool of potential participants than expected to meet accrual goals. Factors that influence subject availability and the decision-making process of participating families must be considered for successful recruitment. Figure Figure

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Ineligibility of prostate cancer patients in the VA Connecticut Healthcare System (VACHS) to participate in clinical trials due to comorbidities

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.5169 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 5169-5169

Author(s):

T. M. Mayer ◽

W. K. Kelly ◽

J. Concato ◽

H. Chao

Keyword(s):

Prostate Cancer ◽

Clinical Trials ◽

Cancer Patients ◽

Healthcare System ◽

Patient Population ◽

Performance Status ◽

Phase Iii ◽

Medical Conditions ◽

Eligibility Criteria ◽

Major Phase

5169 Background: A large proportion of prostate cancer patients receive their care within the VA Healthcare System. As this is a population affected by complex comorbidities, they may be underrepresented in oncology clinical trials. Our objective was to quantify the frequency with which castrate resistant prostate cancer (CRPC) patients in VACHS would be excluded from major phase III randomized controlled trials. Methods: We reviewed records of all prostate cancer patients at the VACHS between 2004–2007 and identified patients with CRPC. We reviewed eligibility criteria of 24 major phase III clinical trials, from 2006 onwards, studying investigational drugs for CRPC and created a “master list” (ML) of the most pertinent criteria. We analyzed our patient population according to both the ML criteria and to the TAX327 study criteria. Results: We identified 106 patients with CRPC, excluded 7 patients with insufficient medical records, and analyzed 99 patients. Performance status and life expectancy could not be accurately assessed from most charts and were excluded as specific criteria (though reflected in other serious medical condition). Major reasons for exclusion according to ML/TAX327 criteria include: 10/10 other malignancy within 5 years; 11/14 abnormal laboratory parameters; 27/30 other serious medical conditions; 3/4 abnormal cardiac function. ML list only exclusions: 5 active angina; 1 unstable DM; 1 major GI surgery; 1 contraindication to steroids. Serious medical conditions included: active cardiac disease, dementia, serious neurologic, psychiatric, vascular, pulmonary or hematologic disease, and poor performance status or compliance. Overall, 45% (45/99) of patients were excluded when using both the ML and TAX327 criteria. Conclusions: Approximately half of CRPC patients in the VACHS between 2004–2007 did not meet eligibility criteria for major therapeutic trials for CRPC. This retrospective review demonstrates that VA patients are underrepresented in randomized clinical trials for CRPC and are a special population due to their complex comorbidities. These findings underscore the importance of designing better clinical trials for CRPC with less barriers for this underrepresented but common patient population. No significant financial relationships to disclose.

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Carbon dioxide versus air insufflation enteroscopy: a systematic review and meta-analysis based on randomized controlled trials

Endoscopy International Open ◽

10.1055/a-0574-2357 ◽

2018 ◽

Vol 06 (06) ◽

pp. E637-E645 ◽

Cited By ~ 3

Author(s):

Julio Aquino ◽

Wanderley Bernardo ◽

Diogo de Moura ◽

Flávio Morita ◽

Rodrigo Rocha ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Data Extraction ◽

Meta Analysis ◽

Ambient Air ◽

Quality Analysis ◽

Cochrane Library ◽

Eligibility Criteria ◽

Co2 Insufflation ◽

Significant Difference

Abstract Objectives To compare the insufflation of CO2 and ambient air in enteroscopy. Search sources The investigators researched the electronic databases MedLine, Cochrane Library, Central, LILACS, BVS, Scopus and Cinahl. The grey search was conducted in the base of theses of the University of São Paulo, books of digestive endoscopy and references of selected articles and in previous systematic revisions. Study eligibility criteria The evaluation of eligibility was performed independently, in a non-blind manner, by two reviewers, firstly by title and abstract, followed by complete text. Disagreements between the reviewers were resolved by consensus. Data collection and analysis method Through the spreadsheet of data extraction, where one author extracted the data and a second author checked the extraction. Disagreements were resolved by debate between the two reviewers. The quality analysis of the studies was performed using the Jadad score. The software RevMan 5 version 5.3 was used for the meta-analysis. Results Four randomized clinical trials were identified, totaling 473 patients submitted to enteroscopy and comparing insufflation of CO2 and ambient air. There was no statistical difference in the intubation depth between the two groups. When CO2 insufflation was reduced, there was a significant difference in pain levels 1 hour after the procedure (95 % IC, –2.49 [–4.72, –0.26], P: 0.03, I2: 20%) and 3 hours after the procedure (95% IC, –3.05 [–5.92, –0.18], P: 0.04, I2: 0 %). There was a usage of lower propofol dosage in the CO2 insufflation group, with significant difference (95 % IC, –67.68 [–115.53, –19.84], P: 0.006, I2: 0 %). There was no significant difference between the groups in relation to the use of pethidine and to the oxygen saturation. Limitations Restricted number of randomized clinical trials and nonuniformity of data were limitations to the analysis of the outcomes. Conclusion The use of CO2 as insufflation gas in enteroscopy reduces the pain levels 1 hour and 3 hours after the procedure, in addition to the reduction of the sedation (propofol) dosage used.

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EPID-25. HOW MANY PATIENTS IN A REAL WORLD GLIOBLASTOMA POPULATION MEET ELIGIBILITY CRITERIA IN CLINICAL TRIALS?

Neuro-Oncology ◽

10.1093/neuonc/noz175.325 ◽

2019 ◽

Vol 21 (Supplement_6) ◽

pp. vi80-vi80

Author(s):

Erlend Skaga ◽

Marthe Andrea Skretteberg ◽

Tom Børge Johannesen ◽

Petter Brandal ◽

Einar Osland Vik-Mo ◽

...

Keyword(s):

Clinical Trials ◽

Median Survival ◽

Real World ◽

Performance Status ◽

Geographical Area ◽

University Hospital ◽

Study Patient ◽

Eligibility Criteria ◽

Oncological Treatment ◽

Severe Comorbidity

Abstract In population series of glioblastoma (GBM) the median survival is < 1 year. For patients eligible for combined oncological treatment (surgery, radiotherapy (RT) and temozolomide (TMZ)) the median survival raises to 15 months. These patients are younger, have higher performance status and less comorbidity compared to the total GBM population. The extent of selection bias of GBM patients enrolled in clinical trials is, however, unclear. Using the Cancer Registry of Norway and the Brain Tumor Database of Oslo University Hospital, all patients diagnosed with GBM between 2012 and 2016 within a defined geographical area that received all oncological treatment at Oslo University Hospital were identified. Their hospital charts were retrospectively investigated and all patients were evaluated for the possibility to be included in clinical trials according to standard criteria from recent published phase 3 studies. We defined three time points for possible enrollment in trials: before-, halfway through-, and after concomitant RT/TMZ. We identified 424 patients of whom 26 (6.1%) did not undergo surgery. The median survival in the population was 11.7 months. Of the patients that underwent surgery (biopsy or resection), the median survival progressively increased with additional oncological treatment; no RT/TMZ 1.1 months, only RT 7.9 months, RT/TMZ 13.9 months. A potential study patient group≥18 years undergoing surgery for a supratentorial GBM with ECOG ≤2, with normal bone marrow, hepatic and renal function and no severe comorbidity or oncological disease constituted 54% of the population before start of RT/TMZ. Patients adhering to RT/TMZ-treatment and without tumor progression represented 46% and 43% of the population halfway through- and after concomitant RT/TMZ, respectively. The survival of patients that could be included in clinical trials was significantly higher (p< 0.001) than patients not fulfilling standard criteria. Our data suggest a significant patient selection in clinical trials from a real-world GBM population.

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P166 Multimorbidity in SLE, a barrier to clinical trial eligibility: results from the BILAG-BR

Rheumatology ◽

10.1093/rheumatology/keab247.162 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Sarah Dyball ◽

Sophie Collinson ◽

Emily Sutton ◽

Eoghan McCarthy ◽

Ben Parker ◽

...

Keyword(s):

Clinical Trials ◽

Real World ◽

Phase Iii ◽

Research Support ◽

Exclusion Criteria ◽

Eligibility Criteria ◽

Chi Squared ◽

The Mean ◽

Double Blinded ◽

Age And Sex

Abstract Background/Aims Stringent inclusion and exclusion criteria are employed in SLE clinical trials. Organ dysfunction and co-morbidities are common exclusion criteria which may affect how representative trials are of real-world SLE populations. We aimed to apply published trial eligibility criteria to patients with SLE in a large national register. Methods A literature review of all major published double-blinded randomised phase III trials in non-renal SLE was performed. Common inclusion and exclusion criteria were applied to all patients recruited to the BILAG-Biologics Register (BILAG-BR), a large UK-wide register of SLE patients. Data on comorbidities for all patients registered was collected. The mean (SD) number of co-morbidities was calculated. Patients were then classified as being eligible or ineligible. Groups were compared initially using a chi-squared or Wilcoxon rank-sum test and logistic regression model was used to test the age and sex adjusted association between trial eligibility and comorbidities. Results Common inclusion and exclusion criteria were identified from 12 published trials. When applied to the 837 patients recruited to BILAG-BR, 562 (67%) patients would not be eligible for inclusion in these trials. Ineligible patients had a shorter disease duration (2.9 vs. 5.1 years, p < 0.01), but were similar in age (P = 1.0), sex (P = 0.7) and ethnicity (p = 0.5) to those who were eligible. Of eligible patients, 128 (53%) had 1 or more comorbidities compared with 340 (60%) who were ineligible (p = 0.05). The mean (SD) number of comorbidities was 0.9 (1.2) vs 1.2 (1.3) for eligible and ineligible patients respectively. After adjusting for age and sex, inclusion in clinical trials was associated with fewer comorbidities (OR 0.81, 95% CI 0.70, 0.94, p < 0.01). Conclusion Patients with multi-morbidity are more likely to be ineligible for SLE clinical trials. Evidence from real world studies and registers are therefore needed to fully understand the safety and effectiveness of new therapies. Our data also underscores the need to develop more pragmatic eligibility criteria for clinical trials. Disclosure S. Dyball: None. S. Collinson: None. E. Sutton: None. E. McCarthy: None. B. Parker: Consultancies; GSK, AstraZenica, UCB, Abbvie, Pfizer, BMS, Celltrion. Grants/research support; GSK, Sanofi Genzyme. I. Bruce: Consultancies; GSK, Medimmune, AstraZenica, Eli Lilly, Merck Serono, UCB, ILTOO. Member of speakers’ bureau; AstraZeneca, Medimmune, GSK, UCB. Grants/research support; GSK, Genzyme Sanofi, UCB.

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