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Phase I Clinical Research Unit

New Hope for Patients

 

Phase I trials are the cornerstone for advancement of new therapies. A Phase I trial represents the clinical starting point for all new drugs undergoing clinical evaluation in patients. It is a critical step in medications that ultimately receive approval and often represents the first time a drug or compound is being tested in humans.

 

A Phase I study is designed to understand many aspects of an anticancer compound that has shown promising results in the laboratory. For researchers, the goal is to evaluate the compound’s overall safety, determine a safe dosage range, and identify side effects. It also allows researchers to study how the drug will act in the body and whether or not it gives benefit to patients.

 

For patients, participating in a Phase I clinical trial gives them access to some of the latest cancer treatments. Patients who go on these studies are true pioneers as their participation may lead to groundbreaking data that can ultimately lead to newer and better drugs for patients with advanced cancer.

 

At Ankara Oncology Research and Training Hospital Phase I Research Clinic, we provide quality data through timely enrollment of study participants. The Phase I Clinic staff is comprised of a variety of specialized team members including Registered Nurses, Licensed Vocational Nurses, Research Nurses, Study Coordinators, Clinical Research Assistants, and Medical Records Technicians all dedicated entirely to the Phase I program. Staff members are trained in Good Clinical Practices (GCP) and are also highly experienced in the field of oncology. Certifications held within the department include Oncology Certified Nurse (OCN), Advanced Cardiac Life Support (ACLS) and Certified Clinical Research Coordinator (CCRC).

 

Bed capacity

Phase I Research Clinic includes 4 hospital beds for our clinical trial participants. Using state-of the-art technology and a physician data capture system, our highly trained physicians are able to assess patients at bedside to document, grade, attribute adverse events, and enter the data digitally into our electronic medical record (EMR). This permits accurate assessment at point of contact.

 

Treatment

Phase I Research Clinic has a research dedicated treatment room for clinical trial patients. This area includes 2 treatment chairs and 4 bed areas. The treatment staff consists of Registered Nurses who provide direct patient care and include OCN and ACLS certified RNs. They provide IV infusions and oral medications as well as obtain pharmacokinetic, pharmacodynamic and other specimens required during treatment and observation periods.

 

Research Nurses / Study Coordinators

The Research Staff consists of Research Nurses and Study Coordinators who are responsible for protocol management, communication with study sponsors, and patient care. Our research staff is responsive to both patient and study sponsor needs. Each study is assigned a research team member to ensure continuity of care for study patients as well as the needs of the study sponsor. The research staff is closely involved with patient screening, enrollment, education, and patient follow up. They maintain constant communication with study sponsors, physicians, clinical staff, and patients.

 

Data Management

Our data management team consists of experienced Clinical Research Assistants (CRAs) that are responsible for paper and electronic case report form (CRF) completion, and query resolution. The team is highly knowledgeable with electronic data capture (EDC) systems. The CRAs are also responsible for coordinating all aspects of monitoring visits. The team is held to the upmost internal standards to ensure a quality and timely product for the study sponsors. Our data management team undergoes quality and timeliness assessment with the study sponsor at every exit interview to ensure quality standards are maintained.

 

Address : Mehmet Akif Ersoy Mahallesi 13. Cadde No: 56 Yenimahalle / Ankara

Phone : +(90)312 336 09 09

Fax : +(90)312 334 03 52

Web :  http//www.onkoloji.gov.tr

E-Mail : onkolojiresearch@gmail.com