Boston Children's Research Biostatistics and Research Design Center (BARD)

The mission of the Biostatistics and Research Design (BARD) Center is to promote excellence in the design and analysis of research studies through biostatistical and methodological expertise, scientific leadership, and collaborative relationships with investigators.  

Our group includes PhD- and masters-level staff with expertise across a wide range of methodologies, including experimental designs, observational studies, biomarker-driven designs, and phase I-III clinical trials.  We also have extensive experience collaborating with investigators from many medical disciplines (e.g., emergency medicine, gastroenterology, hematology and oncology, neurology, psychiatry, pulmonary and others), in both adult and pediatric populations.  

Our team offers both brief consultations and long-term collaborative project support, tailored to your study and resources.  We offer guidance and collaboration from the study planning stage (methodological design of studies and protocols, grant preparation, power and sample size estimates), through data collection (interim analyses, data quality checks), and on to analytical (data management and biostatistical analysis) and dissemination phases (abstract, poster, and manuscript preparation, including revisions). 

The BARD Center also provides educational offerings (seminars and tutorials) in a variety of topics related to research methodology and biostatistics. Below, we provide more information about BARD Center services, external database resources, education, frequently asked questions as well as staff profiles. 

We welcome the opportunity to work with investigators inside and outside BCH, academic and non-academic alike.

BARD Center services include:

• Full biostatistical project support, tailored to your study and resources
• Long-term collaborations with our faculty researchers
• Study design and grant preparation
• Short term consultations with our staff

For further information, please contact:

Dr. Edie Weller, Center Director
Dr. Michael Monuteaux, Center Assistant Director
Dr. Suzanne Dahlberg, Assistant Director of Clinical Trial Biostatistics & Data Management

The BARD Center faculty and staff can collaborate with investigators on: 

Protocol development/grant preparation

We can ensure that the study objectives, specific aims, and endpoints are well defined, measurable and feasible and advise on appropriate design and methods.  Members can write sections related to research aims, data collection and data management methods, registration and randomization, sample size and power, statistical analysis methods and interim monitoring.

Study design and planning

We provide advice on the most efficient, valid, and feasible study design (eg., cohort, case control, prospective, retrospective, cross sectional, randomized clinical trial, etc.) as well as advice on:

• Appropriate selection of the sample from the target population
• Choice of control group(s)
• Strategies for recruitment and retention
• Data collection methods
• Database design

In addition, we provide guidance on design issues that are unique to the following methodologies:

• Qualitative studies (use of focus groups, semi-structured or cognitive interviews)
• Survey research, including instrument creation/validation and sampling and data collection methods (e.g., in-person or telephone interviews, mail surveys, web surveys)

Randomization

We generate randomization schemes and assignments for single- and double-blind studies. Members work in conjunction with the Research Pharmacy for the implementation of investigator-initiated randomized trials.

Data analysis

We analyze study data, provide interpretation of statistical analysis results, including interpretation of previously published results as well as results of ongoing analyses. This includes guidance on and development of:

• Statistical graphics and tabular displays of data
• Interim or final data analyses
• Data and safety monitoring board reports

In addition, we provide support for analysis issues that are unique to:

• Qualitative studies (advice on how to analyze qualitative data including transcribing and coding of focus groups and interviews)
• Survey research (data analysis from complex survey design, including the use of post-survey adjustments and post-stratification weights)

Manuscript preparation

We can contribute to the writing of manuscripts for submission to peer-reviewed scientific journals and prepare abstracts and presentations for scientific meetings.

The external database resource was developed by the Biostatistics and Research Design (BARD) Center with the goal of informing BCH investigators about external data resources available to conduct their research. It provides valuable information about the data included in each database or repository, and how to access and the cost of access. This resource includes information on databases such as the Ambulatory Health Care Data National Health Interview Study, Healthcare Cost & Utilization Project, Youth Risk Behavior Surveillance System, and the WHO Mortality Database.

Boston Children's Hospital employees can go to the BCH internal website to view the external database resource information. Further detailed information on each resource is provided after the overview table. This includes information on the respondents (age and classification), data type (diagnoses, administrative, billing, survey), years that the data are collected, the purpose and scope and potential challenges/limitations as well as information on database/repository redesign.

The Biostatistics and Research Design (BARD) Center offers educational opportunities for Boston Children's researchers on statistical design and analysis considerations for research studies. We also offer workshops on the use of statistical packages for data management and reporting. The objective of the BARD Educational Program is to impart a practical, conceptual understanding of the content we teach. Specifically, in each course we strive to achieve the following learning objectives:

• An understanding of the purpose/intent of the method
• An understanding of when/under what circumstances the method is applicable
• An ability to interpret the method’s results, in context
• An ability to critically evaluate the scientific literature where the method is used
• An ability to use the method with guidance from a biostatistician, when appropriate 

Educational program offerings

The following table provides a description of the BARD Educational Offerings. BCH employees can register for a course or view our video educational library on the BCH internal website. We also encourage researchers to explore the Harvard Catalyst educational opportunities. Contact BCH.CR.Operations@childrens.harvard.edu with questions.

Who can request help?

Any faculty or trainee at BCH is eligible to request our help.  Clinical, preclinical, or translation research studies are all eligible.

When should I consult with a biostatistician?

As early in the planning stages of your study as possible!

How can I access services?

Use the following flow chart to determine how to access services or fill out an online support request.

How does 'funded support' work?

• "Funded support" is required if the investigator needs more help than a one-hour consult can provide.
• A BARD Center team member and Investigator determine the number of hours/effort needed.
• Budget and scope of work are created and approved by BARD and Investigator.

Please note:

• Rates vary according to expertise and experience.
• Funding is not required if the work is for an extramural grant application that budgets support for the BARD staff member (as co-investigator, or key personnel).
• Trainees (e.g. residents and fellows) with research scholarship requirements can receive 20 hours of support for a discounted rate if BARD Center Members have availability.

How to do I prepare for a consult with a BARD Center member?

• Have your study aims/hypotheses finalized.
• If possible, explore funding resources in case you require additional support beyond the consult.
• Consider whether the degree of collaboration you require with the BARD Center member may entail authorship on the resulting academic product.

How soon after I submit a request can I expect a response?

Someone from the BARD Center will contact you within 10 business days to discuss your request.