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What are clinical trials?

ΚA clinical trial is a form of scientific research that aims to evaluate new diagnostic or treatment methods. These methods may relate to new drugs or treatments, new dosage or a combination of different treatments, such as, for example, simultaneous administration of chemotherapy and radiotherapy.

 

In cancer, the aim of the clinical trials is to substantiate the introduction of more effective treatments, with the least possible side effects, as well as improve quality of life, compared to existing treatments. Only volunteers may participate in these trials.

 

Who monitors the conduct of these trials?

In Cyprus, clinical trials on drugs for human use are conducted only upon approval of the Cyprus National Bioethics Committee (established in 2005 under the Bioethics Law 150(I)/2001) and the Pharmaceutical Services of the Ministry of Health.

 

These mechanisms aim to:

 

  • Protect the individuals participating in the trials (respect of the worth of the individual)
  • Supervise and monitor the trials in order to ensure compliance with Good Clinical Practice (from the Nuremberg Code to the more recently revised Declaration of Helsinki).
  • Safeguard the particularly sensitive personal data of the individuals.

     

Moreover, regular onsite checks are carried out by the Sponsor (Pharmaceutical Company or International Research Organisation), which is responsible for supervising all the work conducted in the context of the trial, to ensure its reliability.

 

What is informed consent?

Patients participate of their own free will and only after they have been provided with written and oral information do they give their consent. No patient can be admitted in a clinical trial without signing a “consent form”. When presenting and explaining this form, the doctor, or a researcher, explains to the patient the purpose of the trial, the procedures, the possible risks and the benefits. Patients are also assured of the confidentiality of the information supplied and the right to refuse to participate or interrupt their participation at any moment should they decide to do so. All information is set out in a consent form drafted in Greek and/or in English.

 

What are the admission criteria?

The trials are subject to criteria based on which the doctor will select the patients who can take part. These criteria mainly relate to age, gender, the type and stage of the disease, blood and biochemical tests, as well as previous treatment and disease history.

 

The decision to participate in a clinical trial is entirely up to the patient and does not affect the patient’s management. 

 

Are there clinical trials currently under way at the Oncology Centre?

The success of the clinical trials depends on the voluntary participation of patients. In Cyprus patients are actively involved in the decisions concerning their health and have the possibility to receive a treatment before it is widely available (clinical trial).

 

Clinical trials currently under way at the Oncology Centre: Clinical_Trials_at_BOCOC_Feb_2020.pdf

 

Patients can consult their doctors regarding the conduct of clinical trials in which they can take part, provided they meet the selection criteria.

 

Clinical Trials Coordinator

Dr. Elisavet Papageorgiou

elisavet.papageorgiou@bococ.org.cy

 

Clinical trials nursing staff

Stylianou Ioannis                                    Loukia Georgiou

ioannis.stylianou@bococ.org.cy             loukia.georgiou@bococ.org.cy