The clinical trials approval process can take months or years. Clinical trials are a vital part of the drug development process. They allow researchers to test potential new therapies or treatments on people to see if they work. But getting a trial approved can be difficult and expensive for a clinical trial company.

In this post, we’ll explain the steps to approval and how clinical trials help in the approval of medicines.

8 Major Steps for Clinical Trial Approval

The approval process for clinical trials involves these steps:

  • Step 1: A sponsor company files an IND (Investigational New Drug) application with the FDA. This is usually done several years before a trial begins, but sometimes it’s done right before.
  • Step 2: The FDA reviews the IND and may ask for more information or details about the trial. The sponsor company also must provide a report on any trials they have already completed. If the FDA is satisfied, they may approve the IND and allow the clinical trial to move forward.
  • Step 3: The sponsor company may ask the FDA to waive informed consent. This is a legal protection that allows for human research without patients knowing about it and giving consent.
  • Step 4: The first test subjects are recruited, often through advertisements or conferences where health care professionals gather. The clinical trial team explains the procedures and risks of the trial and asks the patient to sign a consent form.
  • Step 5: During this phase, the clinical trial team monitors each test subject for severe or adverse events (harmful side-effects that are unexpected). The sponsor company will also analyse any data collected from these patients during the trial. The FDA may send an inspection team to make sure the trial is being conducted properly.
  • Step 6: The sponsor company asks for more patients to join the trial, based on the data collected in Step 4. The FDA also can ask for a patient review committee to review reports and decide whether to continue or modify the trial. If they choose to continue, they might require more information.
  • Step 7: The sponsor company may ask for a ‘centralised IRB’ review. This is when an independent committee reviews the trial data and examines patient issues, such as informed consent and safety, before approving the continuation of the trial. They will make a final decision to continue or end the clinical trial.
  • Step 8: The trial is over, but the sponsor company will continue analysing data and submitting new reports for several years. They also may start on Phase IV trials which involve post-approval studies.


The Importance of Clinical Trials in the Approval of Medicines

1. The Trials Enables Drug Developers to Understand the Medicines

For a new compound or drug to be approved, it needs to go through several rounds of testing in humans on safety and efficacy. The final stage in this process is often a large randomised clinical trial performed with thousands of patients. This gives the researchers an insight into how the drug works and its therapeutic benefit and helps them assess the drug’s safety in people.

2. It Helps To Prevent Unnecessary Deaths

A clinical trial may require a patient who has already tried all available treatments for their illness but hasn’t responded to them or even died due to it. In these exceptional circumstances, participants in a clinical trial can permit the use of experimental treatments.

3. It Helps To Improve Treatments In The Future

Research from your clinical trial may help doctors develop new drugs or treatments for people with similar conditions in the future. It might also lead to better ways of diagnosing diseases so that they can be treated sooner and avoid serious complications. And it can provide valuable information about the long-term effects of treatments, which is particularly important in the case of children and teenagers who are unable to give their consent.

4. The Trials Give You Access to New Treatments

Clinical trials may be your only hope for getting access to a promising new treatment for your condition. At the moment, only a small number of treatments are available for specific conditions. Research from clinical trials is helping researchers to develop new medicines and treatments for diseases like cancer, cardiovascular disease and diabetes, which could help millions of people around the world, lead healthier lives.

5. They Prolong Life

Clinical trials take place all over the world, and so can be very convenient for patients. They also involve more advanced treatment than conventional treatments, so maybe an option if your condition has not responded to other forms of drugs or therapies. Many of these patients will have only a short time to live, but by taking part in a clinical trial, you may get access to treatments that could prolong your life.

Wrap Up

Clinical trials are essential in the drug development process; without them, no medicines would be approved for public use. These types of trials are designed by researchers who want to test out new potential therapies or drugs on people to see the effects and whether they are safe and effective when used on humans. The trials are an actionable base for medicine approval. The clinical trials approval process ensures that a trial is safe to conduct and that participants are safe.