4. Accuracy and Safety in Clinical Trials Click to return to the Clinical Trial main page Clinical trials undergo additional steps to ensure the data is as good as possible. Randomisation of participants Placebo treatments Blind trials Randomised Clinical Trials Randomisation ensures that the participants receiving the drug or placebo are balanced. Researchers enter the details of everyone taking part in the trial into a computer. The computer randomly assigns each person to a treatment group, considering details like disease severity, risk factors, age, and gender to balance the groups. This means participants with similar ages, genders, and medical conditions will be spread out throughout all groups and will not end up in one. What is randomisation? Randomisation in clinical trials is the process of assigning participants to different treatment groups randomly to ensure that each group is balanced and comparable, taking into account factors such as disease severity, risk factors, age, and gender. Why are trials randomised? Randomisation makes the trials fairer and the data more realistic. Most Phase 2 and 3 trials are randomised to avoid results distortion because of any conscious or unconscious bias. Randomising means that if one group does better than the other, it's because of the different treatments and not because of general participants' differences. Placebo-Controlled Clinical Trials Some trials compare a new treatment with a placebo. What is a Placebo? A placebo is a "dummy" drug that looks identical to the treatment. It has no active ingredient, so comparing it to a trial medicine can prove whether it works. Why are researchers using a placebo? The point of giving some participants a placebo is to prevent people from recording side effects or potential perceived benefits that aren't there. Using a placebo also helps to determine if any reported side effects are related to the trial medication. Giving a placebo to a group of people who need treatment for a specific disease isn't ethical. An ethics committee must permit a placebo in the trial to ensure people are not unfairly disadvantaged. Blind Clinical Trials What are blind trials? Blinded trials are conducted by assigning code numbers to participants. These participants receive treatment labelled with these codes, ensuring neither they nor their doctors know if it's the new treatment, standard treatment, or placebo. What are Double-Blind Trials: It is when neither the researchers nor the participants know what they are getting. The list of participants and their code numbers are kept secret until the end of the trial. In an emergency, researchers could determine which trial group a participant was in to ensure that the trial medicine didn't cause the emergency. After the study, participants can inquire whether they were administered a placebo. Navigate to other pages about clinical studies: 1. Clinical Trials Explained: Learn the basics 2. Clinical Trials Process: Start to Finish 3. Types of Clinical Trials 4. Accuracy and Safety in Clinical Trials 5. Phases Of Clinical Trials 6. Clinical Trial: Key Participant Information 7. Clinical Trials Community Questions Manage Cookie Preferences