Future Progress Report on the Design, Biostatistics, and Clinical Research Ethics (DRCRE) Program


1.Improve research quality and rigor by broadly implementing and making available a wide range of supportive resources for new and experienced investigators, through the entire research progression:
  • Implement Studios – a centrally managed series of structured, dynamic sessions bringing together relevant research experts in a particular methodology to focus on a specific stage of research – for full scale, comprehensive support in research hypothesis generation, design, implementation, analysis, and translation in conjunction with other VICTR programs.
  • Provide mechanisms for frequent proactive biostatistical input to minimize bias, improve study designs, record appropriate data and confounding factors, avoid common research obstacles, ensure appropriate sample size, produce sound and safe study design, and apply advanced methods of reproducible statistical analysis and reproducible reporting.
  • Provide mechanisms for proactive ethical input for those research studies that could benefit from a thorough ethical review and input.
  • Support the Scientific Review Committee review process.

2.Develop and incorporate innovative study design methods to improve efficiency, ethics, and impact. a.Expand novel methods of interaction with industry and other external collaborators and partners.

3.Improve biostatistical, methodological, and ethics-related training. Expand innovative methods of teaching modern biostatistics; develop feedback mechanisms to update the curricula and course material with the VICTR experience. Implement an innovative MS and PhD biostatistics program.

4.Research the research process to strengthen the infrastructure by supporting the VICTR Program Evaluator (Dr. Bickman) in analyzing outcomes data generated by VICTR as an experiment to assess research efficiency, collaborative facilitation, promotion of efficient translational research, and identification of best research practices that could be translated to other institutions.

5.The bioethics component of the CTSA DBRE program will leverage the success of the Biostatistics program previously associated with the Vanderbilt General Clinical Research Center and currently also part of the CTSA DBRE program. The biostatistics model has been successful in early review, assessment and, where needed, intervention to facilitate quality translational research.

Component Characteristics - Biostatistics

  • Process:Four biostatisticians and four ethicists provide support, consultation, review, and training for VICTR research.
  • Progress:Personnel recruited, regular meetings arranged, Scientific Review Committee process modified.
  • Selected Projects from 2008:

Component Characteristics - Ethics

  • Process:Lead by Larry Churchill, Ph.D. Assistant Director of the CTSA DBRE and Co-Director of the Center for Biomedical Ethics and Society (CBMES) at Vanderbilt University the Bioethics component consist of Ellen Wright Clayton, M.D., J.D. (Co-Director CBMES), Elizabeth Heitman, Ph.D., and Kirk B. Lane, Ph.D. These parties have dedicated time associated with the DBRE. Additionally, the CBMES consist of additional faculty available for consultation in diverse areas of expertise under the “studio” system as required. To facilitate the ethical reviews and consultation several regulatory mechanism exist that act as first line early review. These include IRB review and approval as well as institutional conflict of interest committees. The VICTR scientific review committee (SRC) may also request ethics consultation if a protocol is judged to benefit from this additional review. Administrative support, facilities and equipment have been described elsewhere.
  • Progress
  • Projects

Major Accomplishments

Major Accomplishments - Statistical Methodological Development

CTSA Consortium, Activities and Contributions

Plans for Coming Year:

  • Continue to support and evaluate the Studio process.
  • Improve and expand the biostatistical input for VICTR research.
  • Incorporate the ethics input into the review process.
  • Support the scientific review process.
  • Look for opportunities to apply innovative study design methods.
  • Expand and improve the teaching of biostatistics and ethics.
  • Create a REDCap database of protocol follow-up to assess outcomes.
  • Recruit another experienced biostatistician to join the CTSA.
  • Define, collect, and analyze metrics to assess VICTR progress.
  • Build an innovative MS and PhD biostatistics training program.
Topic revision: r3 - 26 Apr 2013, JohnBock

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