The Clinical Coordinating Center (CCC) for Pediatric Multicenter Studies provides principal investigators (PIs) at Johns Hopkins All Children’s Hospital with the infrastructure to successfully lead and conduct multicenter pediatric studies. This is accomplished by leveraging the existing resources within the Johns Hopkins All Children’s Institute for Clinical and Translational Research (ICTR) and All Children’s Research Institute (ACRI) and applying them to the overall management and organization of a multicenter study. 
 
Led by a team of project managers (PMs), the CCC manages the project through each phase of the study lifecycle from start-up through close out and manuscript publication. 

• In collaboration with the PI, PMs develop and revise all study documents including the protocol, consent and operations manuals.

• PMs assist the PI in selecting highly reliable sites with a proven track-record of accrual and compliance. 

• PMs maintain CCC IRB approvals (local, single or central) as well as on an ongoing basis the study’s overall Trial Master File (TMF) of regulatory documents. 

• PMs provide training to site staff at initiation as well as ongoing through monthly conference calls and webinars as well as annual investigator meetings.

• In collaboration with the PI and study biostatistician, the PM develops and tests Case Report Forms (CRFs).

• In collaboration with the ICTR Regulatory Affairs/Quality Assurance Unit, PMs perform remote monitoring of a participating site’s regulatory documentation and study data to ensure data accuracy, completeness and integrity. 

For those clinical trials using an investigational drug/device, the CCC interfaces and coordinates with:

• The Johns Hopkins All Children’s ICTR Investigational New Drug/Investigational Device Exemptions (IND/IDE) Unit, to prepare and submit the initial application for IND/IDE to the Food and Drug Administration as well as all amendments and annual reports. 

• The Investigational Drug Services (IDS) Unit, to provide centralized IDS, shipping Investigational Product (IP) to participating sites and maintaining overall IP accountability.

For those studies collecting biological samples, the CCC interfaces and coordinates with the Johns Hopkins All Children’s Pediatric Biorepository to design, prepare and ship kits for sample collection, receipt, and to coordinate return shipment, receipt and storage of biological samples, with accompanying sample tracking information. 
 
The CCC interfaces and coordinates with the Johns Hopkins All Children’s Department of Research & Grants Administration to facilitate all contracting with participating sites and site reimbursement for study activities and milestones.
 
The CCC provides Independent Trial Committee (e.g., Steering, Clinical Endpoint Adjudication, and Data and Safety Monitoring) set-up and management services, depending upon scope and Sponsor mechanism.

Current Studies Supported:

Kids-DOTT

Johns Hopkins All Children’s Hospital is the Clinical Coordinating Center for the Kids-DOTT trial, a definitive multicenter randomized clinical trial to establish the duration of anticoagulation for venous thrombosis in children.

The study will also investigate the use of certain blood thinners in children. The study includes Central Investigational Pharmacy and Central Biorepository roles.

CoVAC-TP Study

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as in-hospital venous thromboembolism (VTE) prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19) including COVID-19 multisystem inflammatory syndrome (CMIS).

PREDICT

Understanding why some children stay healthy throughout their lives, while others develop serious illnesses or learning problems is essential in developing prevention programs to help keep all children healthy.

The PREDICT research study works with children and families to track and evaluate their health and development over time. Understanding what protects children from developing certain conditions and illnesses will help develop future treatment and prevention programs. 

Vorinostat Dose-Escalation Post-Transplant Study

To evaluate the maximum tolerated (MTD) of vorinostat used in combination with low-dose azacitidine after allogeneic hematopoietic cell transplantation (alloHCT) for childhood myeloid malignancies.