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Investigator Sponsored Studies

Areas of Interest

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Integrated Diagnostic Systems

Integrated Diagnostic Systems (IDS) is not accepting new submissions at this time. Please check back in October 2023.

Specimen Management

Comparative safety and performance studies of:

  • BD Vacutainer® Blood Collection Needles, Blood Collection Sets and Accessories:
    • Sample quality
    • Fill rates and fill volume
    • Pain perception
    • HCW Safety (NSIs)
    • Diagnostic accuracy
    • Efficiency
    • Total Cost of Ownership
    • Ease of use and first stick success in cases of difficult vein access (for UltraTouch)
  • BD Vacutainer® Blood Collection Tubes, including those intended for collection of serum, plasma and anticoagulated whole blood
    • Accuracy, reproducibility, sample stability and robustness for high sensitivity immunoassays or assays targeting analytes sensitive to cellular contamination
    • Impact of sample quality issues such as hemolysis, fibrin, underfill, gel artifacts etc. on laboratory practices and efficiencies
    • Total Cost of Ownership
  • BD Vacutainer® Urine Collection Solutions, including those intended for urinalysis and for culture and sensitivity testing
    • Impact on urinalysis sample contamination from using preservative vs. non-preservative tubes
    • Impact of using proper midstream/clean catch technique on sample contamination
    • Impact of using open vs. closed system collection on sample contamination
    • Workflow improvement/efficiencies and healthcare worker safety
  • PAXgene specimen collection products for nucleic acid stabilization including tubes, devices and purification kits
    • Liquid biopsy assay sensitivity for ccfDNA, methylated ccfDNA or multimodality assays in oncology patients and other populations, or paired with treatment outcomes
    • Impact of preanalytical errors on liquid biopsy lab practices and efficiencies
  • ABG syringes: Comparison of regular syringe flushed with bulk heparin solution to professional syringes (Addressing the topic through studies other than clinical studies)
  • ABG collection devices to BD ABG syringes with LiH anticoagulant for the assessment of the following metrics (ABG Collection Syringes: BD A-LineTM Arterial Blood Collection Syringes and BD PresetTM Arterial Blood Collection Syringes):
    • Workflow
    • Sample quality
    • Analyte performance
    • Impact on instrument maintenance / down time
    • Economic impact


Women’s Health & Molecular

  • Impact of patient awareness campaign for OBGYN settings for Vaginitis or Vaginosis and CT/GC screening rates using molecular tests
  • Comparative performance of HPV+ triage in cervical cancer screening – extended genotyping versus dual stain cytology and methylation
  • HEOR analysis of the extended genotyping colposcopy referral in real world settings – impact on long-term patient care and outcomes
  • HEOR analysis of self-sampling in national screening programs – long-term follow-up and cost effectiveness as an adjunct to current standard of care
  • Anal Paps and HPV testing in the management of anal cancer (screening and treatment in the post-ANCHOR study era)
  • Meta-analysis of SurePath, ThinPrep and conventional cytology for the diagnosis of cervical disease.
  • Use of serial extended genotyping for patient management (modeling study -can extended genotyping and persistence monitoring replace current standard of care triage strategies?).  Strategies for both developed and developing screening programs (e.g., top tier risk immediately referred for VIA/treatment in LMICs)
  • Development of cloud-based cell phone results reporting systems for self-collection in LMICs (test kit ordering, centralized results reporting and transmission to individual cell phone users for management and recall)
  • Viral load in the management of HPV+ patients
  • The utility of extended genotyping for the management of head and neck cancers
  • Preference of women for self-collection – urine versus vaginal swab collection
  • Health economics and outcomes research (cost, patient outcomes, reimbursement, etc.): Enteric targeted panels (BD MAX™ EBP, xEBP, EVP, EPP) vs. broad panels (i.e., BioFire® FilmArray® GI Panel or Luminex xTAG® GPP)
  • Geographic stewardship of enteric assays: Geographical distribution of enteric organisms
  • BD MAX® Suite of Enteric Assays (EBP, xEBP, EVP, EPP) compared to traditional culture methods: Performance, patient outcomes, outcomes to assess measure: time to admission/transfer; impact of additional diagnostic tests to ascertain cause of infection time to confirmation of antibiotic therapy; impact on antibiotic consumption
  • Workflow analysis of enteric screening with BD MAX® Suite of Enteric Assays (EBP, xEBP, EVP, EPP) using the BD FecalSwab™ and reflex testing to traditional culture on automated specimen processing systems (i.e., BD Kiestra™)
  • Benefits of using molecular as first screening vs. culture: BD MAX™ MRSA-XT and/or Cdiff MAX
  • Geographical stewardship of BD MAX™ CPO assay as a screening assay: Geographical distribution and prevalence of CPO in the United States
  • Patient management and outcome differences with BD Vaginal Panel compared to other molecular VP assays
  • Advantages of Candida spp. differentiation with BD Vaginal Panel
  • Workflow studies with BD CTGCTV2 and BD Vaginal Panel with BD Molecular Swab (with or without comparator molecular method)


Clinical Microbiology

  • Impact of adoption of automation of microbiology for ID/AST, especially for patients with CRO/CPO/resistant bugs coupled with strong AMS teams- endpoints rate of time to therapy change, rate of therapy change, average time from ID/AST results to therapy change, correlated patient outcomes by subgroup and controlling for underlying comorbidities, by major bug type
  • Chart review, identifying, quantifying and measuring the clinical impact of false negatives in blood culture for suspected blood stream infections (BSI)
  • Economic impact and quality error reduction through implementation of training programs offered by industry (BD Service teams, PAQC, BSI, etc.)
  • Impact of automation and AI (imaging) on sample TAT, quality and efficiency KPI
  • Use of MBT Sepsityper™ in Molecular workflow of positive blood culture bottles: i.e., using MBT Sepsityper™ prior to testing positive blood culture bottles on molecular assays to first screen for available targets (increase the pre-test probability of the molecular assay). Address overall time savings, cost savings, actionable results when organism are identified on MALDI that are not targets on the molecular assay


Point of Care

  • Prospective value realization of adoption of point-of-care testing in retail pharmacies (plus care models for triage and patient management especially with telehealth) – Endpoints around workflow, patient access, billing realization, and patient and provider/pharmacist satisfaction/convenience/usability
    • Ideally starting with acute infections, longer term registrations that follow downstream outcomes of patients via claims tracing for routine testing and monitoring of common comorbidities vs total metabolic panel would be great too
    • Could extend this to at home testing space as well 
Biosciences

Biosciences is not accepting new submissions at this time.

Emerging Clinical Applications in Flow Cytometry

  • Novel clinical flow cytometry assay and evidence development in emerging areas. Proposals will be considered in fields such as autoimmunity, allergy, oncology (including heme and solid tumors), transplant, neurology, cardiology, infectious disease, and others, where development of novel flow cytometry assays may yield unique insights and benefits that address unmet needs in clinical settings.
  • Extending established clinical flow cytometry assays with new biomarkers and/or indications.  Proposals will build on existing clinical flow cytometry assays, particularly existing IVD and/or CE-IVD kits from BD (including Cytognos), as-is or with the option for modest additions or changes in some markers, to develop evidence for new applications and indications.
  • Flow cytometry biomarkers and Companion Diagnostics. Proposals will develop flow cytometry assays and evidence for new or improved predictive or monitoring biomarkers for existing and/or investigational therapeutics.

 

Competitive proposals should include evidence development using relevant clinical samples and/or a clinical study.


Single Cell Multiomics

  • Immune repertoire profiling via single cell sequencing
  • Advances and/or novel research in protein profiling via single cell CITE-Seq
  • Single cell multiomic studies that leverage multiple modalities from a single sequencing read out, such as combined transcriptomics + proteomics, transcriptomics + epigenetics, or other combined omics
  • Deep cellular subset interrogation through flow cytometry enrichment followed by single cell sequencing
  • Evaluations of different single cell CITE-Seq methods and their applicability to different cell types or biological investigations
  • Translational research via single cell sequencing that leads to potential future clinical solutions
  • The use of single cell sequencing for research in infectious diseases
  • Evaluation of rare cell populations using single cell methods


Competitive proposals should include elements highlighting unique and/or differentiating aspects of scM technologies. These may include areas such as cell recovery across cell types, CITESeq signal to noise, QC metrics, reproducibility and repeatability, unique applications in single cell Multiomics, etc.

Medication Delivery Solutions

Vascular Access Devices:

  • Strategies to reduce variation in practice and enable proper device selection and placement
  • Strategies to reduce unnecessary PIV restarts and multiple insertion attempts
  • Solutions to ensure the right catheter for the right patient at the right time
  • Use of guidance technologies including ultrasound guidance, tip location systems and tip confirmation systems improve clinicians’ ability to locate and access veins
  • Health economics and clinical evidence related to difficult venous access patients in peripheral IV catheters


Catheter Care and Medication Delivery:

  • Strategies to reduce vascular access complications and improve patient and economic outcomes
  • Use of appropriate vascular access practices and devices to care for and maintain intravenous lines for the duration of each patient’s treatment
  • Strategies to ensure proper care and maintenance of catheters
  • Best practices to enable safer and more effective vascular access management


Infusion Preparation and Delivery:

  • Strategies to protect healthcare workers from hazardous drug exposure
  • Best practices in the detection of hazardous drug surface contamination
  • Evaluation of the delivery of safe, efficient IV administration solutions
Medication Management Solutions
  • Enterprise-wide inventory optimization
  • Best practices in end-to-end medication safety
  • Strategies and technologies to prevent opioid diversion
  • Medication management in non-acute care settings/ care continuum
  • Best infusion practices to deliver specialty therapies and/or treat special patient populations
Peripheral Intervention

Key ESKD Research Priorities

  • Utilization of a large registry or data base to study outcome data on the following: ​
    • Use of novel hemodialysis catheters 
    • >18 month clinical, economic, and safety outcomes utilizing WavelinQ™ endoAVF, Lutonix™ DCB Catheter, or Covera™​ Vascular Covered Stent
    • U.S. patient data utilizing WavelinQ™ endoAVF; inclusion of underserved patient population​s in analysis
    • Global utilization of WavelinQ™ endoAVF with vessel access obtained via the radial or ulnar arteries​
  • Utilization of Patient Reported Outcomes for cosmesis of arteriovenous access 


Key Oncology Research Priorities

  • Clinical outcomes, QoL and budget impact of Caterpillar™ and Caterpillar-Micro™ arterial embolization device
  • Patient experience, procedural outcomes and economic assessment of Powered Bone and Bone Marrow Biopsy System (Trek™) vs alternative therapies
  •  Optimization of clinical, QoL and economical outcomes in the breast biopsy procedures with the use of EleVation™ (Vacuum Assisted Biopsy) and breast tissue markers in patients with breast lesions
  • Analysis of the clinical, QoL and budget impact of Vacuum Assisted Excision (VAE) versus open excision in benign breast lesions
  • Patient experience, QoL, clinical outcomes and economic impact Brachytherapy in patients with prostate cancer
  • Evaluation of clinical, QoL and economic impact of pleural or peritoneal drainage systems on non-malignant pleural or peritoneal effusions
  • Analysis of the clinical and budget impact of the selection of a vascular access device in patients receiving chemotherapy and other long term intermittent intravenous therapies


Key Venous Research Priorities

  • Utilization of a large registry or data base to study outcome data on the following:
    • Venclose™ System or Maven™ Catheter
    • Venovo™ Venous Stent System


Key Peripheral Artery Disease Research Priorities

  • Utilization of a large registry or data base to study outcome data on the following:
    • Long term outcomes of the Lutonix™ DCB Catheter in peripheral arteries
    • Rotarex™ Rotational Excisional Atherectomy System

 

Urology and Critical Care

Targeted Temperature Management (TTM)

  • Accumulating scientific evidence related to targeted temperature management in adults, neonates or pediatrics
  • The impact of targeted fever control in the ICU
  • The impact of targeted fever control in sepsis
  • The impact of targeted fever control in COVID
  • Quality improvement projects related to bedside implementation of advanced TTM in critical care in a health care system
  • New applications for TTM
  • Utilization of large data bases assessing guideline adherence and outcomes
  • The impact of TTM on healthcare economics


Urology

  • Utilization of a large database or registry to assess the impact of incontinence solutions
  • Use of external catheter solutions to assess efficacy, safety, QOL, use in the home setting, and/or clinical benefits
  • Use of new or current technology to improve Kidney stone management and related outcomes
  • Utilization of a large database or registry to assess the impact of automated urine output (AUO) monitoring on AKI detection
  • Early detection of AKI and the role of automated urine output (AUO) monitoring
  • Quality improvement projects to reduce incidence of catheter associated urinary tract infection (CAUTI)
  • The impact of technologies to improve the management of kidney stones
  • Advancing patient care and furthering clinical guidelines on Incontinence, Urine Output Measurement, and Kidney Stone Disease

 

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