Clinical Trials Unit

About the Clinical Trials Unit
The Clinical Trials Unit (CTU) at KHCC manages and supports all clinical trials at the Center in compliance with institutional, local, and international regulations governing the conduct of clinical trials.
 
The CTU:
  • Works closely with all departments to investigate the feasibility of each clinical trial and its importance to KHCC patients.
  • Works to develop, implement, and improve policies and procedures related to the conduct and management of clinical trials at KHCC in compliance with Good Clinical Practice (GCP) guidelines.
  • Facilitates interdepartmental communication between members of the trial team.
  • Supports communication with the sponsor, local regulatory bodies, and IRB.
  • Oversees audits and inspections on ongoing clinical trials.
 
Clinical Research Coordinators (CRCs)
Clinical Research Coordinators at KHCC are responsible for:
  • Organizing and coordinating the implementation of clinical trial protocols through:
    • supporting patient accrual and follow-up visits
    • patient education and support
    • management of investigational products (shipment, storage, dispensing, retention, return, or destruction)
    • collection and shipment of study-related samples
    • data management activities (extraction, collection, entry, verification and retention)
    • retention of data
    • handling of trial samples and products
    • maintenance of trial master file, archiving, and reporting including adverse events.
They are engaged in continuous education programs at KHCC and are required to sit for the Association of Clinical Research Professionals certification exam after two years of work at KHCC to become certified clinical research coordinators. 
 
Examples of ongoing clinical trials at KHCC:
 

ID

Indication Area

Sponsor

Phase

Principal Investigator

IRB #

Status

1

Colon Cancer

Sanofi-Aventis

Registry

Sameer Yasser

06 KHCC E08

Running

2

Gastroenteropancreatic Neuroendocrine Tumor

Novartis

Registry

Salah Abbasi

09 KHCC 69

Running

3

Metastatic Recurrent and/or Unresectable Renal Cell Carcinoma

Novartis

II

Faisal Al-Badaineh

09 KHCC 58

Running

4

Colorectal Cancer

Sanofi-Aventis

Registry

Yasser Yamin

09 KHCC 59

Running

5

Herpes Zoster

MSD

III

Lina Marei

11 KHCC 05

Pending Start

6

Venous Thromboembolism

Sanofi-Aventis

Epidemiological

Hikmat Abdel-Razeq

11 KHCC 47

Running

7

Non-Squamous

Non-Small Cell Lung Cancer (NSCLC)

Roche

Epidemiological

Salah Abbasi

11 KHCC 49

Running

8

Venous Thromboembolism

Investigator-initiated

Registry

Hikmat Abdel-Razeq

11 KHCC 67

Running