Dataset Information

Feasibility, safety, and adequacy of research biopsies for cancer clinical trials at an academic medical center.

ABSTRACT:

Objective

Research biopsies are an essential component of cancer clinical trials for studying drug efficacy and identifying biomarkers. Site-level clinical investigators, however, do not have access to results on the adequacy of research biopsies for histological or molecular assays, because samples are sent to central labs and the test results are seldom reported back to site-level investigators unless requested. We evaluated the feasibility, safety, and adequacy of research biopsies performed at an academic medical center.

Materials and methods

We retrospectively reviewed the data on 122 research biopsy sessions conducted in 99 patients via percutaneous core needle biopsy for 39 clinical trials from January 2017 to February 2018 at a single institute. We asked the sponsors of each clinical trial for the adequacy of the biopsy samples for histological or molecular assays.

Results

The biopsy success rate was 93.4% (113/122), with nine samples categorized as inadequate for obtaining pathologic diagnosis. Post-biopsy complications occurred in 9.8% (12/122) of biopsies, all of which were mild and completely recovered by the day after the biopsy. The sponsors of clinical trials provided feedbacks on the adequacy of 76 biopsy samples, and noted that a total of 8 biopsy samples from 7 patients were inadequate for analysis, resulting in an adequacy rate of 89.5% (68/76): the reasons for inadequacy were insufficient tumor content for immunohistochemistry (n = 3) and low RNA yield for sequencing (n = 5).

Conclusion

Research biopsies performed at an experienced, multidisciplinary center had acceptable safety for patients as well as practicality in terms of obtaining adequate tissue samples for molecular studies.

SUBMITTER: Lee K

PROVIDER: S-EPMC6690517 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Feasibility, safety, and adequacy of research biopsies for cancer clinical trials at an academic medical center.

Lee Kyoungmin K Lee So Jung SJ Yoon Shinkyo S Ryoo Baek-Yeol BY Kim Sang-We SW Choi Sang Hyun SH Lee Sang Min SM Chae Eun Jin EJ Park Yangsoon Y Jang Se-Jin SJ Park Soo-Yeon SY Yoon Young-Kwang YK Park Seong Ho SH Kim Tae Won TW

PloS one 20190812 8

<h4>Objective</h4>Research biopsies are an essential component of cancer clinical trials for studying drug efficacy and identifying biomarkers. Site-level clinical investigators, however, do not have access to results on the adequacy of research biopsies for histological or molecular assays, because samples are sent to central labs and the test results are seldom reported back to site-level investigators unless requested. We evaluated the feasibility, safety, and adequacy of research biopsies pe ...[more]

PMID: 31404103

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Project description:BackgroundOne of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied. We conducted a survey of investigators performing human subjects research in a single large academic pediatric hospital to better understand characteristics of studies with successful recruitment.MethodsWe conducted a web-based survey from September 2011 to December 2011 of all principal investigators with an Institutional Review Board approved human subjects protocol at Boston Children's Hospital, a pediatric Academic Medical Center. The survey captured various characteristics of the protocols including study design, staffing, resources, and investigator experience and training as well as respondents' perceived barriers and facilitators to recruitment. We used chi square tests and Mantel-Haenszel test for linear trend to examine the relationship between selected predictor variables and the binary outcome of successful vs. unsuccessful recruitment and multivariable logistic regression analyses to examine the simultaneous influence of potential predictors on each outcome.ResultsAmong the 349 eligible investigators, 52% responded to the survey, and 181 with valid data were included in the analyses. Two-thirds of the 87 protocols closed to enrollment reached 80% or more of their target enrollment, whereas, only one-third of the 94 protocols actively recruiting were meeting 80% of their target. Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols. Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods. Other potentially modifiable factors such as number of study visits, study duration and investigator experience were suggestive of being meaningfully related to recruitment.ConclusionRecruiting in person may promote reaching an acceptable target enrollment in pediatric as well as adult clinical research. Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.

Project description:BACKGROUND:Electronic medical records (EMRs) contain a wealth of information that can support data-driven decision making in health care policy design and service planning. Although research using EMRs has become increasingly prevalent, challenges such as coding inconsistency, data validity, and lack of suitable measures in important domains still hinder the progress. OBJECTIVE:The objective of this study was to design a structured way to process records in administrative EMR systems for health services research and assess validity in selected areas. METHODS:On the basis of a local hospital EMR system in Singapore, we developed a structured framework for EMR data processing, including standardization and phenotyping of diagnosis codes, construction of cohort with multilevel views, and generation of variables and proxy measures to supplement primary data. Disease complexity was estimated by Charlson Comorbidity Index (CCI) and Polypharmacy Score (PPS), whereas socioeconomic status (SES) was estimated by housing type. Validity of modified diagnosis codes and derived measures were investigated. RESULTS:Visit-level (N=7,778,761) and patient-level records (n=549,109) were generated. The International Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) codes were standardized to the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) with a mapping rate of 87.1%. In all, 97.4% of the ICD-9-CM codes were phenotyped successfully using Clinical Classification Software by Agency for Healthcare Research and Quality. Diagnosis codes that underwent modification (truncation or zero addition) in standardization and phenotyping procedures had the modification validated by physicians, with validity rates of more than 90%. Disease complexity measures (CCI and PPS) and SES were found to be valid and robust after a correlation analysis and a multivariate regression analysis. CCI and PPS were correlated with each other and positively correlated with health care utilization measures. Larger housing type was associated with lower government subsidies received, suggesting association with higher SES. Profile of constructed cohorts showed differences in disease prevalence, disease complexity, and health care utilization in those aged above 65 years and those aged 65 years or younger. CONCLUSIONS:The framework proposed in this study would be useful for other researchers working with EMR data for health services research. Further analyses would be needed to better understand differences observed in the cohorts.

Dataset Information

Feasibility, safety, and adequacy of research biopsies for cancer clinical trials at an academic medical center.

Objective

Materials and methods

Results

Conclusion

Publications

Feasibility, safety, and adequacy of research biopsies for cancer clinical trials at an academic medical center.

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