What are Clinical Trials?

Summary

A clinical trial is a planned scientific research experiment that involves volunteers and researchers testing a new medical treatment. It is a necessary step to better healthcare for diseases that have no cure. By trialling treatments, researchers can learn about their safety and effectiveness.

Governments around the world require all medical treatments to be proven safe before they are allowed to be prescribed. New drugs must be significantly more effective than current drugs, or they aren’t worth the investment. Clinical trials are therefore highly regulated and monitored by independent review every step of the way.  

Since the 1960’s medical science has made incredible progress. Countless lives have been saved and many have been freed of the burden of chronic illness. Conditions such as heart attack & stroke, diabetes, HIV/AIDS, cancers, polio, and leukaemia, are all conditions that doctors can now treat because of clinical trials.

How do trials work?

From the perspective of a volunteer a clinical trial involves three separate phases.

Screening

During screening the volunteer meets with the research team to go over their health status. Each trial has inclusion and exclusion criteria for safety and research purposes.
This is usually just one appointment

Treatment

The treatment period involves scheduled visits to:

Receive the study drug, or placebo.
Provide blood samples.
Answer questions about symptoms and side-effects.

Follow-up

After the volunteers stop receiving the drug they attend a few more clinic visits to provide samples and answer questions. This helps researchers learn how the drug leaves the body and how long it continues to work.

The frequency of visits and tests required vary by study, but the process is always the same. Some trials have long-term extensions that enable participants to keep using the drug for a longer period of time.

How are participants kept safe?

Trial volunteers have the right to be kept safe from undue harm, and to be made aware of any risks participating might entail. To ensure the safety of volunteers clinical research is structured to have multiple layers of protection.

In addition to the protections outlined below, drugs that are tested in humans must first undergo animal testing for toxicity. Once they pass animal testing, they enter a Phase 1 trial in a small selection of healthy volunteers. These volunteers know that they are the first to try, and the trial is specifically designed to discover drug interaction in the body.

International and National Guidelines

These provide the foundation for how trials should be conducted safely and ethically.

• Declaration of Helsinki – sets ethical principles for medical research involving humans.

• Good Clinical Practice (GCP) – an international standard for designing, conducting, recording, and reporting clinical trials.

• National Regulations – each country has its own laws that enforce participant safety and trial quality. (e.g., FDA regulations in the U.S., EMA in Europe, Health Canada in Canada)

Trial Protocol Design

Before a trial begins, researchers must write a protocol—a detailed plan explaining:

• What the trial is studying

• Who can participate

• What treatments or interventions will be used

• How safety and progress will be monitored

This protocol must be reviewed and approved before any participants are enrolled.

Ethics Committees / Institutional Review Boards (IRBs)

Independent groups of experts and community members who review the trial protocol to ensure:

• Risks are minimized

• Participants are informed and give informed consent

• The trial is ethically justified

They monitor the trial as it progresses to ensure ongoing safety.

Informed Consent Process

Participants must be given clear, understandable information about:

• The purpose of the study

• Possible risks and benefits

• Their rights (like the right to withdraw at any time)

Only after giving voluntary consent can someone join a trial.

Data and Safety Monitoring

Trials often have a Data and Safety Monitoring Board (DSMB)—an independent group that reviews safety data during the trial.

They can pause or stop the trial if safety concerns arise or if clear harm is shown.

Regulatory Authority Oversight

Agencies like the FDA (U.S.) or MHRA (UK):

• Review applications before a trial starts

• May inspect sites

• Evaluate results before approving any new treatment for public use

Ongoing Monitoring & Audits

Sponsors and regulators conduct audits and inspections to ensure:

• The trial is being run properly

• Data is accurate and complete

• Participant rights and safety are protected

Summary: How Are Participants Kept Safe?

• Trials must follow laws and ethical standards

• Protocols are reviewed before starting

• Participants give informed consent

• Independent oversight continues during the trial

• Regulatory agencies enforce rules and conduct inspections

What happens after the trial is finished?

When a clinical trial ends, the information collected is carefully analyzed to understand the effects of the treatment or intervention.

Researchers study the data to determine if the treatment was safe and effective. This includes reviewing side effects, benefits, and how the treatment performed compared to current standards.

Results are often published in scientific journals, presented at conferences, or submitted to regulatory agencies. If a treatment is successful, this is the first step toward it becoming available to more people.

Depending on the results, a new trial phase might begin, or researchers may move forward with applying for approval of the treatment.

Participating in a clinical trial means contributing to knowledge that could help many others. That contribution continues to matter even after the study ends.

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