Grant Development and Collaboration

Grant proposals may include statistical support provided by the BCCC in the grant budget as a percentage of effort for the biostatistician. Statistical support under this structure will be designed to ensure available support to an investigator or department/center that makes this agreement (Grant Submission agreement form with the BCCC. Once funded, a collaborative arrangement between the BCCC and Principal Investigator is created for the duration of the grant. Funding for BCCC support included in the grant proposal budget will need to be agreed upon by the Core Director, and based on the estimated workload for BCCC support per year of the grant. For guidance on effort estimation go to the section below called Guidance to Departments for Effort Estimation of Collaborative Biostatisticians.

Grants that include biostatistical collaboration provided by the Core will need to have funding built into the proposal budget for Core support, as percentage of effort of BCCC statisticians. Any changes to the budget at any time involving the Biostatistical Core support on grants must be approved by the Core Director. In the event that the overall budget is reduced, budget cuts to BCCC must not exceed the percentage that the grant budget is reduced. An Agreement of Support must be signed between the PI and the Core Director concerning the support activities and Core Funding described in the grant proposal, and will go into effect upon award of funding.

The strongest grants are those that have biostatistical collaboration from the beginning of the design process. Generally, grants are more likely to be funded when there are biostatisticians participating in the development of the proposal.

The research design must be developed to accommodate scientific questions of interest. The design must be as efficient as possible in order to improve power and increase efficiency (and potentially save money). Each hypothesis proposed under each aim of the investigation must have a thought out and described plan for analysis in order to appropriately assess them.

In writing a grant proposal, you are essentially asking a funding agency for money. You must demonstrate that scientifically appropriate methods are in place for analyzing the data collected with the funds provided. Adequate statistical power needs to be demonstrated in order to detect the primary questions of interest. Statistical power can be described with an analogy to a microscope. You have a given amount of power in your lens and with that there is a limit to how small of an object you can see. In order to see smaller objects, you can increase the power of your lens. Statistical power is like that, but the “object” you want to see are the answers to the question of interest in the investigation. It may be an effect of a treatment, or a difference between groups. The smaller it is, the more power you need to see it. There are many approaches to increasing power. One is to increase the sample size or amount of information we use to estimate the effect. Another is to have a more efficient study design that minimizes variability, or other noise, in the data and allows you to see the effect clearly. A third is to use statistical methods of data analysis that are more efficient, and more precisely estimate the effect of interest.

Statistical collaboration is essential for providing support in these critical areas of grant development. Since the likelihood of funding increases, with adequate statistical considerations, it is a worthwhile investment. More importantly, it increases the quality of research. It is very disappointing to spend many years invested in research only to find out that it had a biased design or was not appropriately powered.

Additionally, provision of statistical support throughout the study duration is also critical in demonstrating the availability of resources to carry out the described investigation and corresponding analysis, and making statistical inference about the populations of interest.

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 given power.

In our experience, it is not uncommon for statisticians to uncover design issues that must be addressed, prior to conducting analyses. For example, a study design may need to be improved prior to estimating power. We reserve the right to require these types of remediation before the analyses are done.

The BCCC will collaborate in proposal development and will charge for this support activity as a short-term activity, although some funding may be funded under the Miami CTSI. If the proposal development is with a Dept./Center/Research team that is engaged in an ongoing collaboration plan with the BCCC, time for grant development will be provided under collaboration plan, but funding for BCCC support, as a percentage effort for a biostatistician, within the grant budget for the funded investigation for the years of the grant supported research, will be expected. The initial pre-award work will be billed depending on the estimated workload needed for proposal development. For a specific proposal development, an initial meeting will be scheduled, and there will be no cost incurred. After the meeting, the workload will be estimated to determine budgetary considerations.

Common Intake Form

Grant proposals require intellectual contribution from teams with unique areas of expertise, biostatistics being one of them. It is optimal that biostatistical expertise be included as early as possible in the proposal development. The BCCC should be contacted at least two months before a grant submission deadline in order to provide assistance with proposals. If not, the BCCC will provide support only if we have resources available.

Departments frequently ask for guidance in estimating biostatistics effort on grants, and sometimes when we are not asked, insufficient effort is budgeted. To accurately estimate the effort needed to perform duties for a grant, biostatisticians take into consideration many different aspects of the project. Many of these considerations are outlined on the UC Davis website. These guidelines were referenced to create the table below that explains the overall effort needed for projects of various sizes and complexities.

While the UC Davis document and the table below provide substantial information to help understand a potential range of effort that could be required for a biostatistician to collaborate on a project, the actual budget depends greatly on:

• the particular skillset of the collaborative biostatistician,
• the biostatistician’s salary,
• the effort availability of the biostatistician during the span of the grant/project work.

Therefore, these guidelines should not be used as a replacement for appropriate effort estimation by a biostatistician. We recommend that these documents are used in conjunction with direct interaction with your biostatistics collaborator to estimate project effort.

In an ideal setting, we advise that a collaborative biostatistician should have at least two months’ notice to collaborate on the development of a grant. With less time to learn about the project needs, the effort estimation may be less accurate. Therefore, we recommend addressing effort estimation at the start of formulating your proposal.