BCCC Newsletter December 2012

DIVISION OF BIOSTATISTICS Biostatistics Collaboration & Consulting Core Bccc NEWSLETTER

DECEMBER 2012

Message from the Director Shari Messinger, M.E., Ph.D. Biostatistics support to clinical and translational researchers through the Research Design and Biostatistics Component of the Miami CTSI is now being offered by BCCC. Emphasis is being placed in the area of culturalized health research, in line with the theme of the Miami CTSI, supporting interdisciplinary clinical and translational research that focuses on health problems highly prevalent in ethnic-/racial-minority and medically underserved communities.

The mission of the Research Design and Biostatistics Component of the Miami CTSI is to lead, advise, educate, and train the next generation of clinical/ translational (C/T) researchers in the design and analysis of their studies. The allocation of the Miami CTSI resources has guidelines in which the consideration for each study is taken. Priority is given to junior investigators preparing NIH grants, senior investigators focusing on new approaches and investigators with NIH and intramurally funded studies that require supplements to achieve major interdisciplinary breakthroughs. See page 3 of this newsletter for more detailed information regarding prioritization for CTSI resources.

Educational opportunities such as biostatistics clinics and roundtables will continue to be offered.

These will be announced as they become available. Initial Meetings for investigators seeking to obtain support for research will continue to be available by appointment as well as office hours for quick walk-in consultation. The forms for these requests can be found on our website www.biostat.med.miami.edu/core.

It is strongly encouraged that investigators requesting biostatistical support in developing NIH grant submissions for the approaching January deadline, contact our office as soon as possible, in order to allow adequate time for quality support. See page 5 for a description of appropriate timelines for requesting biostatistical supporl.

If you are interested in obtaining BCCC support funded by the Miami CTSI, or to learn more about the available biostatistics support and corresponding procedures and policies, please contact Maria Jimenez-Rodriguez at mjrodriguez@biostat.med.miami.edu. Please indicate on your message the nature of your research and if it falls into the prioritized areas mentioned above.

You may also visit our website at www.biostat.med.miami.edu/core for forms and additional information. We would be happy to meet with you to learn about your specific research needs.

HOW CAN WE SUPPORT YOUR RESEARCH? We are located in the Clinical Research Building 1120 N.W. 14th Street, 10th Floor (R‐669) Miami, FL 33136

Biostat Clinics January 14, 2013 Speaker: Dr. Hua Li

February 18, 2013 Speaker: Kaming Lo, M.P.H.

March 18, 2013 Speaker: Dr. Kris Arheart

April 15, 2013 Speaker: Dr. Jennifer Clarke

May 13, 2013 Speaker: TBA

LEADERSHIP and PERSONNEL

Shari Messinger Cayetano, M.E., Ph.D. Associate Professor, and Director of BCCC, Robert Duncan Ph.D. Professor, and Biostatistician Hua Li, M.D., Ph.D., M.S. Assistant Scientist, and Biostatistician Kaming Lo, M.P.H. Biostatistician

Biostat Roundtable

Maria Jimenez-Rodriguez, M.A.L.S. Sr. Administrative Assistant, BCCC Administrator, and Editor of BCCC Newsletter All collaboration and consulting activities involve MS and Ph.D. level BCCC staff statisticians.

The members of the BCCC cover a wide range of interests and statistical expertise and have consulting experience in a variety of subject matter areas.

12/20/12—Sample Size 1/3/13—Sample Size 1/17/13—Experimental Design 1/31/13— Experimental Design 2/14/13— Sample Size 2/28/13— Sample Size 3/14/13— Hypothesis Testing 3/28/13—Hypothesis Testing

What topic of interest would you like to discuss?

Visit our website: www.biostat.med. miami.edu/core

Mission Statement To ensure that the appropriate statistical methodology is incorporated into research.

December 2012

FEES Fees for all support activities is based on the University approved hourly rate FY 2012: $105, for UM affiliates $152, for Non-UM affiliates.

All fees are based on UM policy B020 for Recharge, or Cost Centers.

BCCC Newsletter

SUPPORT OPTIONS Short Term Support Activities

Statistical support on a short term, per hour basis. Short term consultations work best when investigators have well defined questions with relatively small datasets.

Fees are determined based on the estimated number of hours required for the specific support activities requested.

Ongoing Collaboration Plan Dedicated support to a group engaging in a collaboration plan. Statistical support under this structure is designed to ensure available support to an investigator or department/center that makes this agreement.

Grants: Grant development can be as a short term activity or as part of a collaboration plan.

Biostatisticians in the BCCC are available to participate in grant development in various ways including: -Assisting with the formation and operation of a proposal development team; -Assisting the investigators in refining study questions and measurement methods; -Developing study and experimental designs; -Writing statistical analysis plans; -Computing precision, power, and sample sizes necessary to achieve a given precision of estimation or a desired power.

-Provide ongoing support to funded research as line- itemother support, on grant budget.

2

More Information on CTSI Prioritization All research proposals and requests for these CTSI services and resources should incorporate ideas and approaches from multiple disciplines and/or propose innovative research initiatives that have the potential to translate into improved health.

CTSI research priorities: 1. K-awardees 2. Institutionally-funded pilot studies Priority among the above Investigators will be given to those whose proposed studies, in order of preference: 1. Address health disparities/minority health/medically underserved communities or elucidate/tease effects of racial/ethnic minority status 2. Propose the creation of new fields of study at the intersection between existing fields 3. Are translational, and interdisciplinary (e.g. co-investigators) from at least two schools/disciplines 4. Are collaborative (e.g. co-investigators) from different scientific/clinical fields/subspecialties 5. Are multifaceted in research support demands, e.g. requires use of more than one CTSI component’s services/resources or resources from another NIH-funded program grant (e.g. P-awards, U-awards, R-awards, T-awards, etc.)

Within the above schema, applications are encouraged in the following scientific foci: 1. Obesity-related issues, substance abuse, sexually transmitted diseases, or low-birth weight babies (priorities established by the CTSI Community Advisory Board) 2. Therapeutic development If supported with CTSI funds: Work supported under the Miami CTSI should include the following acknowledgment: This work was conducted with support from the Miami Clinical and Translational Sciences Institute (National Center for Advancing Translational Science (GRANT # 1UL1TR000460)). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Miami CTSI, the University of Miami, and its affiliated academic health care centers, or the National Institutes of Health.

December 2012

BCCC Newsletter

3

BIOSTATISTICS ROUNDTABLES

MANUSCRIPT and GRANT REVIEW

The BCCC conducts roundtables on various topics available to the UM research community.

The BCCC is available to review your manuscript or grant proposal with focus on the statistical considerations of the research.

For example, topics of interest may include sample size and power calculations, hypothesis testing, pilot studies, experimental design, and others.

These roundtable sessions begin with a presentation, and then opens for discussion among participants where the attendees can ask any other specific questions of the statisticians.

If you are interested in attending these roundtables they will be announced in the Clinical and Research listservs, e-Update, and e-Veritas communications.

Tentative dates and topics can be found on page 2 of this newsletter.

Any suggestions as to specific topics of interest you would like to see offered, please email them to Maria Jimenez-Rodriguez at mjrodriguez@biostat.med.miami.edu.

The intent of this support activity is to carefully review the documents and provide feedback and suggestions to the authors/investigative team regarding any statistical issues that may be of a concern.

The fee for this support is based on 5 hours of dedicated BCCC time.

If you are interested in this support, or have any further questions please email them to mjrodriguez@biostat.med.miami.edu.

SUPPORT ACTIVITIES 1. Study Design 2. Randomization Schemes 3. Statistical Analysis Plan (SAP) 4. Sample Size Estimation or Power Analysis 5. Statistical Analysis 6. Manuscript Review 7. Abstract/Manuscript Preparation 8. Grant Preparation 9. Survey/Questionnaire Design 10.Protocol Review 11.Safety Committee 12.Grant Review 13. Other

BCCC DECEMBER 2012 Schedule The offices of the Biostatistics Collaboration and Consulting Core (BCCC) will be closed from December 24, 2012 through New Year’s Day, Tuesday, January 1st , 2013, and re-opening on Wednesday, January 2nd, 2013.

There will be on-call support available in case of any emergency that cannot wait until January 2nd , 2012.

For any request of urgent nature, please e-mail Maria Jimenez-Rodriguez at mjrodriguez@biostat.med.miami.edu, type 'URGENT' in the subject line, and someone from the Biostat Core will contact you.

We are respectfully requesting that all anticipated requests for support be received by BCCC no later than December 14th, 2012, in order that we have time to accommodate the request(s) before the holidays.

December2012

BCCC Newsletter

4

When to start incorporating statistical considerations into research?

An investigator should include statistical considerations into his/her research during the design phase. Statistical considerations for a study involve defining the hypothese in testable form, selecting the most efficient study design, defining the outcomes and other variables, considering sample size issues, and determining the statistical analyses that specifically address each hypothesis.

Quality of proposal/manuscript

A statistician who might not have expertise in a specific research area will also need extra time in getting familiar with the subject matter of the investigation. For grant submissions, it is recommended that statisticians should be involved in the study far away enough from the submission deadline in order to allow adequate time to ensure proper incorporation of statistical science to research and quality support.

Most high quality researches take early statistical considerations!

1 month

2 months

Time before deadline when biostatisticians start to involve

Timelines Advance contact is necessary to allow sufficient time to address your needs before deadline . Below are minimum times required: Proposal Development/Grant application – two months. It is most advantageous that biostatistical expertise be obtained as early as possible in the proposal development.

At least six weeks. If it is a first submission and we don't have enough time, our contribution will demonstrate statistical involvement but will likely be criticized for being incomplete. If it is a re-submission, we may at least two months to provide quality input.

Proposal Development Review (completed) – 2 weeks. We may find statistical issues, and if it is desired the BCCC support the protocol from that point, more time will be required.

Statistical analysis – 3 weeks, depending on the type of analysis and study design.

Abstracts – 1 month, depending on statistical analysis.

At least one month. If it is less than a month before the deadline, we may be able to help you with some simple summary statistics. There may not be enough time to do anything more complex.

Manuscript preparation-3-4weeks, after statistical analysis is complete.

As the deadline approaches, the likelihood that we can provide helpful statistical support diminishes.

On a case by case basis, we may be able to accommodate requests that are closer to the dead lines than described in the timelines above. In order to provide anything of real quality, appropriate planning for adequate time is essential.

December 2012

BCCC Newsletter

5