Introduction

The clinical trials test investigational treatments to make sure they’re safe and effective before they’re available to everyone. Before an investigational treatment makes it to a clinical trial, it first goes through preclinical studies in drug development. This stage is where researchers test the investigational treatment option in a lab to see if it has potential.

If the outcome of the tests is positive, the investigational treatment may move into the phases of drug development, which is also classified as clinical trials. In these phases, the investigational treatment option is tested on people to ensure it’s safe and effective.

The Four Phases of Clinical Trials

Clinical trials follow a systematic and step-by-step process, ensuring that new drugs are both safe and effective before reaching the public. This process is divided into four key phases, each with a distinct purpose and methodology. Every phase is carefully designed to address specific scientific and medical questions about the investigational treatment, such as its safety profile, appropriate dosage, effectiveness in treating the targeted condition, and potential side effects. By progressing through these phases, researchers gather critical data that helps regulatory agencies determine whether the drug should be approved for widespread use.

• Phase 1 – Evaluates safety and determines the appropriate dosage in a small group.
• Phase 2 – Assesses effectiveness and identifies potential side effects.
• Phase 3 – Verifies benefits of the investigational treatment and compares it to existing options.
• Phase 4 – Conducts post-approval by the U.S. Food and Drug Administration (FDA) to track long-term effects.

The phases flow chart is a great way to see how investigational treatments go from testing to FDA-approval. Each clinical trial phase is designed to make sure an investigational treatment is safe and effective before it reaches the public. It’s a crucial process that helps bring investigational treatment options to patients.

What to Expect as a Participant

The trial moves through different clinical testing phases, with doctors carefully monitoring progress. In some cases, an adjudication clinical trial step is used to evaluate patient outcomes and ensure accurate results. It’s all about safety, transparency, and finding the best investigational treatments. You can discuss your interest in clinical trials with your doctor. They can provide personalized advice and may have information about local studies.

Here’s a breakdown of the journey from initial interest to active participation:

1. The clinical study process starts with informed consent, where you’ll receive details from the clinical trial site about a specific study. Before participating, you’ll go through an informed consent process where researchers will explain the study’s purpose, procedures, risks, and benefits. This ensures you’re fully informed before deciding to participate. This step, known as obtaining informed consent to participate in clinical research, ensures you fully understand everything before deciding to participate.

   Keep a record of the trials you’ve requested more information on and follow up as needed. Being proactive can help you find a suitable trial more efficiently. Utilizing our Comprehensive Guide to Choosing Clinical Trials and consulting with healthcare professionals can help you navigate the process with confidence.

2. Once you express interest, by filling out an online questionnaire, in AutoCruitment helping to match you with studies for which you may qualify, the AutoCruitment team will contact you through email, phone, or text to confirm your interest, ask additional questions about medical history, current medications, and lifestyle factors. This follow-up assists AutoCruitment with finding studies that you may qualify for and allows AutoCruitment to proceed with the next steps in referring you to a clinical trial site for further evaluation.
3. If you meet certain eligibility criteria, you will be referred to the clinical trial site for a more detailed assessment. Before joining the trial, you must go through the informed consent process, where researchers may explain the study’s purpose, procedures, duration, risks, benefits, and rights, and provide you with a written informed consent form (ICF) for review. Additionally, staff at the clinical trial site will answer any questions that you may have.
4. After signing the ICF, you may undergo a more detailed screening, which may include medical history review, physical exams and lab tests (blood work, imaging, etc.). These tests will confirm if you fully meet the study’s eligibility criteria. If eligible, the clinical trial site will determine if you can be enrolled in the study.
5. Once enrolled, you will begin the study, following the protocol (study plan) outlined by researchers. This may involve taking investigational medications or attending scheduled visits for health assessments. Medical professionals will take lead of your investigational treatment including keeping records of your symptoms, side effects, or lifestyle changes. They will closely monitor you to ensure your safety and track the investigational treatment’s effects.
6. After completing the investigational treatment phase, you may enter a follow-up period where researchers continue monitoring long-term effects, collect additional data on investigational treatment effectiveness, and provide next steps for continued care (if needed).
7. You may receive compensation for your time and travel. Once the study ends, you may be informed about results or given access to ongoing investigational treatment (if beneficial).

Interested in Learning more about clinical trials at AutoCruitment?

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Conclusion

By understanding the clinical trial process, knowing where to look, and addressing common concerns, you can take control of your healthcare journey with confidence.

Making an informed decision is key, and the right resources can make all the difference.