Who can join our clinical trials?

Every clinical trial has unique requirements for participating. The requirements are known as eligibility criteria. Some of the considerations for you to join a clinical trial include:

• Your age and gender
• Type of Disease
• Stage of the disease
• Your treatment history
• General Health
• If you have more than one disease or other medical conditions

 

Our team takes you through a prescreening process if you are interested in joining any of our clinical trials. The prescreening process will have you answer some questions about your health, and medical history, and filling a study questionnaire either at our Clinical Research Unit in Eldoret or over the phone.

 

Once our team determines that you are a good candidate, you will be taken through the next steps which include consenting and screening.

 

Screening

 

Screening in clinical trials is a process of checking whether you meet the eligibility criteria for the study. The process may involve:

• Going over your medical history
• Medical examination and review
• Blood tests
• Additional tests relevant to the study

 

Once the clinical trials determine you meet the criteria for the study, you’ll be given all the information about the study and let you decide whether to take part in the study.

 

If you don’t take part in the study, you’ll continue with the standard treatment for your disease.

 

Informed Consent

 

Clinical trials are voluntary. Every patient taking part in a clinical trial has a right to information and can ask questions before participating in the study. One of our doctors or assistants will take you through the entire study information including eligibility criteria, study risks, and benefits. If you decide to take part in the study, you will sign an informed consent.

 

An informed consent form shows you understand the study details and risks and benefits of the study. A study assistant, nurse, or doctor will take you through the informed consent document and help understand every section before signing.

 

Our study doctors, nurses, or assistants will always communicate new information about the study at every stage of the trial. You are free to continue or leave the study at any stage without fear and you will continue to receive your standard treatment without any problems.

 

What to expect during clinical trials?

 

Clinical trials are not like normal cancer or other disease treatments. You will be monitored closely with regular visits and tests. Your doctors will ask you how you feel and may give you a questionnaire or diary to help keep track of your symptoms and condition.

In addition, the clinical trials team will try to find out as many side effects and symptoms you may have after taking the study drugs. Moreover, they’ll try to find out your quality of life after taking the drugs with a diary or questionnaire.

 

Some clinical trials study the cost implications of treatment and care. Some of these implications include:

• How often you need to visit a doctor
• Whether you can work during treatment
• Whether you can travel
• etc.

 

Your privacy and safety during the study

 

Clinical trials are highly regulated to protect patients and caregivers. At ICI, our clinical trials go through several Institutional Review Boards to ensure the safety and privacy of our patients. We also follow all national and drug approval agency laws and regulations governing research and medical data with regular reviews to keep up with all requirements for a safe clinical trial.

 

All of our clinical trials staff receive special training and certification before, during, and after a study such as the Good Clinical Practice (GCP) certification. GCP is an international ethical and scientific quality standard for designing and conducting clinical trials.

 

Internally, we also have policies and standard operating procedures (SOPs) that staff adhere to at all times, not to mention the national laws and regulations.