Study Design

Any successful study is a product of solid design. Our team has more than 20 years experience in this area. We provide high quality consultation and training to guide you through the process of designing your study.

Statistical Planning

Proper statistical planning for your study is critical. We can assist with several key activities in this area including:

  1. Generating a testable hypothesis.
  2. Estimating appropriate sample sizes.
  3. Identifying predictor and outcome variables.

Protocol Development

In addition to statistical planning, developing a solid clinical research protocol is extremely important. We can assist with:

  1. Understanding and implementing regulatory requirements in protocol development.
  2. Defining adverse events for your a protocol.
  3. Defining the primary and secondary endpoints of the protocol.
  4. Determining enrollment and withdrawal requirements.

Data Collection Development

Successful research studies are based on consistently collected, reliable data. We can assist investigators with creating appropriate data collection instruments and case report forms (CRFs) for capturing clinical data including, but not limited to, subject demographics, physical examination results, medical history, laboratory results, radiological results, and microbiological results. In addition we can help the investigator develop a corresponding data dictionary with variable identification to facilate building the study database and performing statistical analysis.

Database Development

While the primary data collection tool for a study is often a set of paper case report forms, for proper statistical analysis, the data must be converted to an appropriate electronic format that lends itself to searching and sorting the dataset as well as selecting data subsets. Our team has extensive experience building data collection systems using either the REDCap System developed by Vanderbilty University or from ground up using a tiered client-server or cloud-based design.

Biostatistical Support

Appropriate statistical analysis is key to arriving at the appropriate conclusions of the study. Our group has doctoral level statisticians with extensive experience in practical application of various statistical methods.

Statistical Analysis

Members of the CTRSU are experts in a number of specialized areas of biostatistics, bioinformatics, and epidemiology including the following:

  • Sample size estimation
  • Multivariable modeling
  • Machine learning
  • Propensity score analysis
  • Instrumental variables analysis
  • Survival analysis
  • Geospatial analysis

Our team primarily uses the R statistical environment (http://cran.r-project.org) but we each have expertise with a number of different software packages such as SAS, SPSS, Minitab, MedCalc, Python, and ArcGIS.

We offer training on biostatistical methods annually as well as on a case-by-case basis. This includes basic biostatistical methods such as sample size estimation, assessing correlation and association, evaluation of confounding, medical diagnostic accuracy statistics, as well as using statistical programming languages.

We offer free statistical consulting by appointment and we offer fee-for-service or work effort reimbursement for analytical assistance. Please call Kim Buckner at (502) 852-1770 or e-mail us ctrsu@louisville.edu for more information on our fee structure as it varies on a case-by-case basis.

Study Execution

Running a clinical research study can be a challenge depending on the scope of the study and the complexity of the protocol. Our group can assist in several areas for executing your study.

Clinical Study Coordination

Conducting clinical studies can be a laborious process. Having experienced clinical study coordinators can ensure a successful protocol population-based. Our group has numerous study coordinators certified by the Association of Clinical Research Professionals that can help investigators screen potential subjects, consent subjects for enrollment in a study and collect quality enrollment and follow-up data.

Data Quality and Validation

Reliable data collection is one issue in producing a quality study. Another critical issue is ensuring the quality and validity of the data. Transcriptions errors from original source documents or from the paper CRF to the electronic system, missing data points, invalid data points (e.g. outside of valid ranges) and inappropriate variable typing cause major problems during the analysis phase. Our team can assist investigators and clinical study coordinators with developing procedures and protocols to verify the validity of the data collected for the study to ensure it will analyzable.

Standard Operating Procedures Documentation

A clinical trial often involves writing one or more standard operating procedures (SOPs) for accomplishing various activities. Our group can assist you with writing your SOPs so they adhere to the protocol and regulatory requirements.

Biorepository Development and Maintenance

The Respiratory Biorepository Program is an IRB-approved program that has been established by the Division of Infectious Diseases to collect and store biological specimens linked to patient clinical data. This will allow researchers to identify undiscovered respiratory pathogens or biomarkers in support of improving diagnosis, prognosis, and response to therapy in the management of respiratory infectious diseases patients. Biological specimens in the biorepository include, but are not limited to, nasal-pharyngeal swabs, oro-pharyngeal swabs, serum, urine, and bronchioalveolar lavage.

The Clinical and Translational Research Support Unit (CTRSC) oversees data processing and data management for this program. Clinical data are stored in REDCap (Research Electronic Data Capture), a software toolset and workflow methodology for electronic collection and management of research and clinical trial data.

Services

  • Store biological specimens collected through IRB-approved studies. Sample submission form
  • Release biological specimens to investigators with de-identified data such as diagnosis, etiology, treatment, laboratory data, and date of diagnosis or outcomes. Sample release form

Location

Respiratory Biorepository Program
Division of Infectious Diseases
Department of Medicine
505 South Hancock St
Kosair Charities Clinical Translational Research Building, Room 527
Louisville, KY 40202

Contact

Mawadda Alnaeeli, Ph.D. (mawadda.alnaeeli@louisville.edu)

Grant Preparation and Submission

In the academic setting, grant writing is critical to maintaining a constant and consistent funding stream. However, medical students, residents, fellows and doctoral students are often not formally trained in preparing grant proposals. Our service provides one-on-one consultations and short training sessions to assist faculty and students in the University of Louisville with preparing grant proposals.

Specifically our service assists clients with:

  1. Identifying appropriate sources of federal, state, local and private funding sources.
  2. Understanding typical grant requirements.
  3. Building a grant writing toolbox to reduce the time it takes to write a grant.
  4. Writing a grant proposal.
  5. Submitting the proposal and monitoring its progress in the review process.

Publication

Abstract / Poster Development and Submission

The first step in disseminating the results of any research project often includes submission of an abstract for poster presentation at a local, national or international conference. Our group has many years of experience developing and submitting abstracts to conferences around the world. We can assist investigators with a systematic approach to developing high quality abstracts and/or posters which can increase the likelihood of acceptance.

Poster Printing

In addition to assisting investigators with developing posters for conferences, we can print them for a nominal fee. Consult our Poster Printing Service Page for more information.

Manuscript Preparation

Publishing your study results in high quality peer-reviewed scientific journal is a critical step in clinical and translational research. This mechanism of information dissemination is the most efficient way of communicating research to other investigators. Our group has published extensively in numerous high quality journals such as The Lancet Infectious Diseases, Clinical Infectious Disease, European Respiratory Journal, Public Health Reports, Journal of Emergency Management, American Journal of Orthopedics and the American Journal of Respiratory and Critical Care Medicine. We have a well-established methodology for writing and preparing manuscripts for publication that includes rigorous internal team reviews and collaborative writing sessions.

Dedicated to improving the quality and efficiency of clinical and translational research at the University of Louisville.

MedCenter One
Suite 140-B
501 East Broadway
Louisville, Kentucky 40202
(502) 852-1148
 ctrsu@louisville.edu