RECRUITING METASTATIC PATIENTS INTO NON-SMALL CELL LUNG CANCER STUDIES (NSCLC)- LESSONS LEARNED FROM A NON-INTERVENTIONAL STUDY OF NSCLC PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) METASTASES (METS) AND NON-CNS METS.

Author(s)

Crane G¹, Khan N², Hipp J³, Gally S⁴, Pedrós M⁵, Surinach NL⁶, Gondos A⁷, Hammerschmidt S⁸
¹Roche (RWD), Welwyn Garden City, UK, ²QuintilesIMS, Mendham, NJ, USA, ³Roche Pharma AG, Grenzach-Wyhlen, Germany, ⁴Roche SAS, Boulogne-Billancourt, France, ⁵QuintilesIMS, Barcelona, Spain, ⁶IMS Health, Barcelona, Spain, ⁷QuintilesIMS, Frankfurt, Germany, ⁸Klinikum Chemnitz gGMBH, Chemnitz, Germany

Presentation Documents

PRS75--strong-u-crane-g-u-sup-1-sup-strong-khan-n-sup-2-sup-hipp-j-sup-3-sup-gally-s-sup-4-sup-pedros-m-sup-5-sup-surinach-nl-sup-6-sup-gondos-a-sup-7-sup-hammerschmidt-s-sup-8-sup-br-sup-1-sup-roche-rwd-welwyn-garden-city-uk-sup-2-sup-quin ...

OBJECTIVES: To describe challenges of recruiting CNS mets patients in a multi-center, prospective, observational study in France and Germany.

METHODS: To be included, patients were required to be ≥

RESULTS: Currently, 31 sites are enrolled in the study. The non-CNS mets cohort recruitment was closed in February 2017. Recruitment for CNS mets cohort is continuing and was 64 patients on June 19^{th
CONCLUSIONS: Major reasons for poor recruitment were patients’ performance status, refusal to participate in the study and the diagnosis window. This study provides valuable information that can help design future CNS mets observational studies. Recommendations are to oversample sites that see CNS mets patients, and find a balance between suitable I/E criteria and the reality of recruiting to represent real world population.}

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PRS75

Topic

Study Approaches

Topic Subcategory

Registries

Disease

Oncology

Presentation