A clinical trial is a research study conducted to find out if medical treatments can improve people’s health. A medical treatment can be a drug, medical device, medical procedure, or a change in a person’s behaviour such as diet or exercise.   

Clinical Research is essential to aid the development of new treatments for medical conditions.  

All trials are approved by applicable regulatory authorities such as FDA (Food & Drug Administration) in the United States and MHRA (Medicines and Healthcare Products Regulatory Agency) in the UK to ensure that risk is as low as possible and is worth any potential benefits.  

You can be assured that each trial is ethical, and your rights are fully protected. In addition to regulatory approval, each trial must receive research ethics approval. This further ensures the rights, safety, dignity, and well-being of research participants is protected.  

Each trial once approved by the Ethics Committees and Regulatory authorities follows a carefully constructed plan known as “protocol”. You will know full details of the protocol before the study begins. 

You may gain access to new drugs and other treatments sometimes years before they are widely available. 

• You will be monitored closely for any side effects. 
• You will have the chance to take an active role in your own healthcare. 
• You will be making a valuable contribution to clinical research 

A clinical trial can sometimes require more time and medical attention than normal care. This can include doctor visits, phone calls, more treatments, or a more complicated treatment regimen. (Ask your doctor for information about the trial you are considering.) 

• The treatment might not work. 
• The treatment might cause serious side effects. 
• Even if a new approach helps some patients, it might not help you. 

Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits and information on the privacy of your medical records. 

If you want to participate you will sign a consent form that details all the information that has been discussed with the research team. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form you still have the right to leave the study at any time and for any reason. 

Informed consent continues throughout the trial. This will give the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.

• What is the purpose of this clinical trial? 
• What phase is this clinical trial and what does that mean? 
• Why do researchers believe this new treatment might be effective? 
• Has this treatment been tested before? 
• Have there been other trials like this one? If yes, what were the results? 
• What kinds of patients will be in the clinical trial? 
• How many patients are needed for the clinical trial? 
• How long will the trial take?   
• Will I find out about the results of the clinical trial? 
• Eligibility Requirements 
• Why is this clinical trial a good fit for me? 
• What are my treatment options if I don’t join this trial? 
• Are there other clinical trials that might help me? 
• Potential Benefits and Risks 
• How could this clinical trial help me if I join? 
• What are the possible risks? 
• How will I know if the treatment is working? 
• Practical Concerns 
• What will I have to do if I join? 
• Will I have to change my daily activities or my diet? 
• Who will oversee my care? 
• What type of long-term follow-up care is part of this study? 
• Who will pay for treatment? 
• If I have questions about the trial, whom can I contact? 

Yes, you can withdraw from the trial at any stage of the trail for any personal reason.