Researchers conduct ophthalmology clinical trials according to a protocol, a detailed plan that explains how the trial will work, what will be done during the trial, and why.
All ophthalmology clinical trials have guidelines about who can join. These guidelines ensure that research results are reliable and help reduce risk to study participants.
A potential drug must go through three phases of testing to prove it is safe and effective before it can receive approval from the US Food and Drug Administration (FDA). After the drug is approved, further studies will continue to monitor safety and effectiveness.
What is a study protocol?
A protocol is a plan that explains how the exam will work, what will be done during the exam, and why. The trial sponsor, often the pharmaceutical company developing the therapy or drug, designs the protocol for the ophthalmology clinical trials. When designing a protocol, sponsors often work with the foundation to get feedback from research experts and people with CF.
Key information in the log includes:
- How many people will attend
- Who can participate
- What tests will the participants take and how often
- What type of data will be collected
How long will the study last?
What medications and dosages participants will receive, if appropriate.
A protocol must go through many layers of review before a study can begin. Once the protocol is approved, the principal investigators will be selected by the sponsor to conduct the study. Each investigator follows the same protocol to ensure that the study is conducted in the same way at each participating center.
Ensuring impartiality of examinations
Bias refers to human choices or other factors (non-protocol related) that may affect the results of the study. For example, if doctors could choose which people to put into comparison groups in a study, some might assign sick people to the treatment group and healthier people to the placebo group. Doctors may not even realize they are doing this, and it could affect test results.
Researchers can avoid bias by designing a study in certain ways:
Randomization helps ensure that researchers do not introduce bias into the study. In many ophthalmology clinical trials that test the effectiveness of a drug, half of the participants receive the drug in question. The other half receive a placebo that contains no medication. Randomization involves assigning participants to these comparison groups by chance rather than selection.
Blinding can also help avoid bias. In a blinded study, researchers won’t know which participants are getting the treatment and which are getting a placebo.
Who can participate?
All ophthalmology clinical trials have guidelines about who can join, known as inclusion and exclusion criteria. These criteria exist to ensure that the results of the trial are accurate and useful, as well as to protect the safety of the participants.
The criteria are based on factors such as:
- Age
- CFTR mutation
- Current health status
- Previous treatment history
- Other medical conditions
The criteria depends on the type of exam. For example, if researchers are testing how well a particular antibiotic works against Pseudomonas aeruginosa, then the study would have inclusion criteria specifying that only people with CF who are infected with the bacteria can participate in the study. Those who do not have this bacterial infection would be excluded from the study.
Also read:- 5 Signs You May Need to See Ophthalmology CRO
Another example is the age requirement for the exam. Drugs work differently in children than they do in adults. In order to reduce the risk to younger children with CF participating in the study, the drugs must first be shown to be safe and effective in adults with CF. Ophthalmology clinical trials of a new drug usually begin in adults aged 18 and older before moving to younger age groups.
The four phases of clinical research
For any new drug to gain approval from the Vial Food and Drug Administration (FDA) and become available to the public, it must go through three phases of interventional ophthalmology clinical trials to demonstrate that it is safe and effective in treating a disease. If the FDA approves the drug, researchers will continue to monitor safety and effectiveness in what is known as a phase 4 study.
The infographic below shows a breakdown of the questions researchers are trying to answer, the number of participants needed, and the length of participation in each phase of the research.
Please note that the time refers to the time required to participate in the exam. Not the entire length of the phase. It takes more time to enroll participants and process and analyze the results of each phase. Lastly, it usually takes 10 to 14 years from the time a drug is discovered. In the lab to its possible FDA approval for people with CF.
