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PS1-11: Specimen Collection Within the Cancer Research Network: A Critical Appraisal.

ABSTRACT: Background and Aims: The Genomics Working Group (of the Cancer Research Network (CRN) Pharmacovigilance Project) explored single-site experiences with genomic studies to understand challenges and opportunities for collecting and using biological specimens. Its specific aims were to:Methods: We distributed a survey on existing biospecimen availability to principal investigators at all CRN Pharmacovigilance sites. Information collected included the number of specimens, storage methods, and type of specimens available. Investigators were also asked to identify past and current studies at their institutions in order to collect information on successful specimen collection strategies. A literature review was conducted both to identify potential barriers to participation and to understand the feasibility of various recruitment procedures. Benefits and limitations of ?opt-out? and ?opt-in? specimen collection methods were examined. Lastly, we developed study documents, including recruitment letters and informed consent forms, for future saliva and blood specimen collection efforts.Results: Two of the CRN HMOs currently have large-scale banked blood or saliva specimens (>20,000) within existing repositories. One site has two large-scale studies (>20,000 participants each) with banked specimens able to provide DNA for future research. Whole blood or blood components are the most commonly collected specimen types, and multiple CRN sites have access to banked tumor blocks. There were 33 past or current studies that included biospecimen collection. There was a trade-off between intensive data collection requirements and recruitment yield, cost, and participation burden.Conclusions: There is great potential for collection, storage, and use of biospecimen samples for research within the CRN. For future collection efforts, ?opt-out? models allow fast sample accrual, but impact data de-identification requirements. ?Opt-in? models allow for broad data collection, but are resource and time intensive. Pathology time and support may be a barrier to future use of stored samples.

SUBMITTER: Hemmes M

PROVIDER: S-EPMC3006521 | biostudies-other | 2010 Dec

REPOSITORIES: biostudies-other

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Project description:Systematic collection of fresh tissues for research at the time of diagnostic image-guided breast biopsy has the potential to fuel a wide variety of innovative studies. Here we report the initial experience, including safety, feasibility and laboratory proof-of-principle, with the collection and analysis of research specimens obtained via breast core needle biopsy immediately following routine clinical biopsy at a single institution over a 14-month period. Study eligibility criteria consisted of patients age 18 or older who were undergoing a clinical breast needle biopsy. Patients providing informed consent underwent one or two additional core biopsies following collection of all necessary clinical specimens. In total, 395 patients were approached and 270 consented to the research study, yielding a 68.4% consent rate. Among consenting patients, 238 lesions were biopsied for research, resulting in 446 research specimens collected. No immediate complications were observed. During the same period, zero complications were reported among the non-research procedures (1622 breast biopsy procedures). Representative research core specimens showed high diagnostic concordance with clinical core biopsies. Flow cytometry demonstrated consistent recovery of hundreds to thousands of viable cells per research core. Among a group of HER2+ tumor research specimens, HER2 assessment by flow cytometry correlated highly with immunohistochemistry (IHC) staining, and in addition revealed extensive inter- and intra-tumoral variation in HER2 levels of potential clinical relevance. Suitability for single-cell transcriptomic analysis was demonstrated for a triple-negative tumor core biopsy, revealing substantial cellular diversity in the tumor immune microenvironment, including a prognostically relevant T cell subpopulation. Thus, collection of fresh tissues for research purposes at the time of diagnostic breast biopsy is safe, feasible and efficient, and may provide a high-yield mechanism to generate a rich tissue repository for a wide variety of cross-disciplinary research.

Project description:BackgroundSince the start of the COVID-19 outbreak, a large number of COVID-19-related papers have been published. However, concerns about the risk of expedited science have been raised. We aimed at reviewing and categorizing COVID-19-related medical research and to critically appraise peer-reviewed original articles.MethodsThe data sources were Pubmed, Cochrane COVID-19 register study, arXiv, medRxiv and bioRxiv, from 01/11/2019 to 01/05/2020. Peer-reviewed and preprints publications related to COVID-19 were included, written in English or Chinese. No limitations were placed on study design. Reviewers screened and categorized studies according to i) publication type, ii) country of publication, and iii) topics covered. Original articles were critically appraised using validated quality assessment tools.ResultsAmong the 11,452 publications identified, 10,516 met the inclusion criteria, among which 7468 (71.0%) were peer-reviewed articles. Among these, 4190 publications (56.1%) did not include any data or analytics (comprising expert opinion pieces). Overall, the most represented topics were infectious disease (n = 2326, 22.1%), epidemiology (n = 1802, 17.1%), and global health (n = 1602, 15.2%). The top five publishing countries were China (25.8%), United States (22.3%), United Kingdom (8.8%), Italy (8.1%) and India (3.4%). The dynamic of publication showed that the exponential growth of COVID-19 peer-reviewed articles was mainly driven by publications without original data (mean 261.5 articles ± 51.1 per week) as compared with original articles (mean of 69.3 ± 22.3 articles per week). Original articles including patient data accounted for 713 (9.5%) of peer-reviewed studies. A total of 576 original articles (80.8%) showed intermediate to high risk of bias. Last, except for simulation studies that mainly used large-scale open data, the median number of patients enrolled was of 102 (IQR = 37-337).ConclusionsSince the beginning of the COVID-19 pandemic, the majority of research is composed by publications without original data. Peer-reviewed original articles with data showed a high risk of bias and included a limited number of patients. Together, these findings underscore the urgent need to strike a balance between the velocity and quality of research, and to cautiously consider medical information and clinical applicability in a pressing, pandemic context. SYSTEMATIC REVIEW REGISTRATION: https://osf.io/5zjyx/.

Project description:BackgroundMedical research is a central part of any residency training. In view of the new Saudi orthopedic committee promotion regulation that mandates each resident to participate in a research project, the challenges that stand in the way of completion of substantial research within surgical residency must be investigated. The aim of this study was to assess the practice, attitudes, perception, and limitations associated with research among residents in the Saudi orthopedic program in the central region.MethodsA cross-sectional study was conducted between June and July 2020 using an online-based survey. The total number of study participants was 128 orthopedic residents out of the 191 residents enrolled in the central region program. Data were analyzed, and descriptive statistics in the form of frequency and percentage were determined, analytical tests were performed with P < 0.05 being statistically significant.ResultsMost residents (95 %) participated in a research project during residency. Most projects (53.10 %) were case reports followed by retrospective studies (48.40 %). The majority (79.70 %) did not attend a research methods course during residency. Experience in research differed significantly (P < 0.05) by age, residency year, and center. The mean involvement score was significantly higher among males at 3 (± 1) than among females at 2 (± 0) (P < 0.001). Only 40.60 % have access to orthopedic journals, and the same percentage (40.60 %) knew how to Critique original articles. There was a statistically significant difference in the accessibility score according to the training center. Lack of faculty support and mentorship were the main barriers to medical research at 62.50 and 39.10 %, respectively. A total of 68.80 % reported that funding was not available through their institutes.ConclusionsIn Saudi Arabia, the level of meaningful clinical research and publications by orthopedic residents is still low. The results of this study should be taken into consideration before the implementation of the new promotion criteria in the centers under the umbrella of Saudi orthopedic committee.

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PS1-11: Specimen Collection Within the Cancer Research Network: A Critical Appraisal.

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