Building a Research Core Road Map and Lessons Learned Scott A. LeMaire, MD Professor of Surgery and of Molecular Physiology and Biophysics Vice Chair for Research, Michael E. DeBakey Department of Surgery Director of Research, Division of Cardiothoracic Surgery Baylor College of Medicine Co-Editor-in-Chief, Journal of Surgical Research

180 full-time faculty Eleven divisions Abdominal Transplantation Cardiac Transplantation & Circulatory Support Cardiothoracic Surgery Congenital Heart Surgery General Surgery General Thoracic Surgery Pediatric Surgery Plastic Surgery Surgical Oncology Surgical Research Vascular Surgery & Endovascular Therapy Four hospitals

Why build a research core?

Problems with silos Redundancy High cost Lack of standardization Insufficient support for junior investigators

Todd K. Rosengart, MD Professor and DeBakey-Bard Chair

Todd K. Rosengart, MD Professor and DeBakey-Bard Chair Research Mission Conduct important research in surgical disease to improve treatment and quality of life for affected patients

Todd K. Rosengart, MD Professor and DeBakey-Bard Chair Research Mission Conduct important research in surgical disease to improve treatment and quality of life for affected patients Train future leaders in academic surgery

Todd K. Rosengart, MD Professor and DeBakey-Bard Chair 2013 Faculty Strategic Retreat

Todd K. Rosengart, MD Professor and DeBakey-Bard Chair 2013 Faculty Strategic Retreat #2 Develop support infrastructure for surgical research Priority

Mission To provide support, guidance, and education for successful research projects to members of the BCM Department of Surgery

Mission Funding strategy

100% 0% Time Proportion of Funding

Departmental sources 100% 0% Time Proportion of Funding

Departmental sources 100% 0% Time Proportion of Funding Grants and contracts

Departmental sources 100% 0% Time Grants and contracts Proportion of Funding Funding strategy Gain faculty buy-in Launch trials Submit grants Add personnel to grants and study contracts Establish fees for study activities Share revenue with investigators

Departmental sources 100% 0% Time Grants and contracts Proportion of Funding

Mission Funding strategy Building the team

Number of Research Core Team Members ½ 17

Building the team Director Responsibilities Overall direction Hiring Establishing roles & procedures Day-to-day operations Project oversight Prioritization

Building the team Director Barbara W. Trautner, MD, PhD Director of Clinical Research

Building the team Director Administrative support Responsibilities Communications Meeting management Scheduling Human resources Metrics

Building the team Director Administrative support Finance expert Responsibilities Overall core finances/budget Hiring logistics Research fund tracking and allocation Clinical trial invoicing

Building the team Director Administrative support Finance expert Grants & contracts specialists Responsibilities Pre-award grant development Grant submission Post-award account management Study budget creation and negotiation

Building the team Director Administrative support Finance expert Grants & contracts specialists Research coordinators Responsibilities Regulatory compliance Study start-up Protocol submission/revision Study enrollment Data collection Monitoring visits

Building the team Director Administrative support Finance expert Grants & contracts specialists Research coordinators Database specialist Responsibilities Database selection and development Data transfer Data compliance and security Database maintenance and troubleshooting

Building the team Director Administrative support Finance expert Grants & contracts specialists Research coordinators Database specialist Statistician Responsibilities Assisting investigators with study design Data analysis Statistics sections of grants and manuscripts Education

Building the team Director Administrative support Finance expert Grants & contracts specialists Research coordinators Database specialist Statistician Scientific editor Responsibilities Reviewing and editing grant applications and manuscripts Writing projects Communications Education

Building the team Director Administrative support Finance expert Grants & contracts specialists Research coordinators Database specialist Statistician Scientific editor Medical illustrator Responsibilities Creating figures for grant applications, presentations, and publications Graphic design and logistics for communications Education

Number of Research Core Team Members ½ 17

Number of Research Core Team Members ½ 17

EAMWOR T K THERE’S ENOUGH BLAME FOR THIS STUPID IDEA TO SPREAD AROUND TO EVERYONE.

Growth and adjustments Increasing faculty utilization 2013 – 52 faculty members assisted 2014 – 114 faculty members assisted

Growth and adjustments Increasing faculty utilization 2013 – 52 faculty members assisted 2014 – 114 faculty members assisted Increasing clinical trials activity 2014 – 4 active clinical trials 2015 – 18 active clinical trials 2015 – 12 trials in start-up phase

Growth and adjustments Increasing overall funding

Growth and adjustments NIH funding tripled since 2014

Growth and adjustments Meetings 2013 Weekly team meeting to discuss each project 2015 Cycle of three meetings Research core team meeting Grants meeting Clinical trials meeting

Growth and adjustments Meetings Policies and standardized procedures 2013 None 2015 Fee structure, budget development, protocol submission, invoicing, fund allocation, project prioritization…

Industry trials: Level 1 trials: 100% core supported Revenue shared with PI Level 2 trials: core does start up but not enrollment Core charges start up fee ($10,000) Level 3 trials: core is only the BCM point of contact Core charges initiation fee ($3,500) Investigator initiated trials Vary by core role and budget Core fees for clinical trials

Growth and adjustments Meetings Policies and standardized procedures Project management 2013 Excel spreadsheet 2015 Online Clinical Trial Management System

Growth and adjustments Meetings Policies and standardized procedures Project management Communications 2013 None 2015 Weekly research updates by Targeted grant and abstract deadline notices Updates at faculty meetings Annual reports

Thank you!