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An Overview of Clinical Trials

May 2, 2019

While clinical trials are extremely important to study all types of medicine, clinical trials for oncology are particularly important as they help researchers advance new treatment options.

During a clinical trial, participants volunteer to try new drugs or treatments so that investigators can measure their effectiveness and safety.

Every cancer treatment that enters the market must go through a clinical trial before being approved by the Food and Drug Administration (FDA). The public doesn’t typically hear much about these trials unless either something goes wrong or a major breakthrough is made. But it’s thanks to millions of participants in these clinical trials that advancements have been made in treating many forms of cancer.

 

Phases of Clinical Trials

Clinical trials are all about research. The goal of a clinical trial is to gather additional data regarding a potential cancer drug or treatment to see if it’s valid to enter into the market. Because of this, the process of even beginning a clinical trial — let alone having a drug approved for sale — is rigorous and extensive.

 

Pre-Clinical

The process begins in the pre-clinical phase, which is laboratory research. These typically begin with cell studies, which are tests conducted in test tubes or Petri dishes on either human or animal cancer cells. If the results from cell studies appear to be favorable, researchers will move on to testing the treatment in live animals to see how the treatment impacts a living being. This process can take many months or even years to complete.

If the treatment looks favorable, the researchers — referred to as clinical investigators — begin the process of submitting paperwork to the FDA for approval to begin a clinical trial. This paperwork includes all results from the Pre-Clinical testing as well as:

 

Manufacturing Information

This is information about how the treatment is made and who is responsible for manufacturing. The American Cancer Society explains that the FDA uses this information to determine “whether the company can make batches of the drug that will always be exactly the same.”

 

Study Protocols & Clinical Investigators Evaluation

This is the information that explains the details of the desired clinical trial. Think of the study protocols as a proposal for research. It includes how the clinical trial would be run in extensive detail, including any risks to potential participants. The clinical investigators are also evaluated at this point to determine whether or not they are qualified and capable of the proposed research.

Next, the investigative team must agree to acquire informed consent of all participants in the clinical trial. Informed consent is not just a signature on a form; researchers must display that they have given as much information as possible to potential participants, including offering time for questions and assisting in understanding.

And finally, the team must agree to have the completed clinical trial reviewed by an institutional review board (IRB). It is only after all of these steps are completed that a clinical trial may begin.

 

Phase I Clinical Trial

If the clinical trial is approved, the first phase is intended to determine several things about a treatment’s safety:

  • The safety of the drug/treatment and proper dosage
  • The most appropriate way to take the drug (orally, intravenously, etc.)
  • The reaction of the human body to the drug, including side effects  
  • The treatment’s effectiveness in fighting cancer

This phase of the trial typically involves a small number of participants; some use as few as 15 while others use around 100. It can take several months to complete this phase of the trial. Approximately 70 percent of treatments that go through Phase I of a clinical trial advance to Phase II.

 

Phase II Clinical Trial

In the second phase of the trial, the effectiveness of the treatment is tested. In many cases, this involves the randomized introduction of a placebo through a blinded study, in which neither the investigators nor the participants know which patients have received the drug being tested.

This phase can potentially involve anywhere from 100 to several hundred patients, depending on the desired depth of research. It can take up to two years to complete.

Phase II is a rigorous test as to whether a drug is potentially safe and effective enough to go to market; only 33 percent of drugs that complete a Phase II clinical trial are recommended for Phase III.

 

A Note on Progress in Early Phase Clinical Trials:

Historically, early phase clinical trials (Phase I and Phase II) have been completed in an academic hospital setting and drugs were virtually never approved during this Phase. In recent years, however, we have seen a dramatic improvement in the efficacy of these early phase clinical trials. Drugs are being approved from Phase I and II trials because they are proving to be more effective and/or safer than the current standard treatment. Now we have to opportunity to bring these trials out of the academic/research setting and into our physician-run practices–providing better patient care and treatment options in a community setting.

 

Phase III Clinical Trial

The purpose of the third (and final) phase is to compare the treatment to others already existing in the market. It involves as many as several thousand participants in randomized and blinded studies to gain a more in-depth understanding of the effect of the drug on a broader population.

This phase is extensive and can take several years to complete. However, drugs and treatments that are recommended for Phase III testing are likely to be approved by the FDA: typically 70-90 percent of drugs that complete Phase III are approved for consumer use.

 

Phase IV Clinical Trial (Post-Approval)

Even after a treatment is approved by the FDA and made available for use, the clinical trial may continue. The goal of this post-approval phase is to compare the drug’s long-term effectiveness and cost-effectiveness to other treatments already in the market. It is possible for a drug to be taken off the market or have additional restrictions added to its use at this point.

 

Clinical Trials: Not Just For Drugs

While we tend to think of clinical trials as being used for new drugs, they can also be done for other types of treatments, including surgeries, radiation, or other alternative treatments. They can also be completed on previously approved drugs to see how they work in combination with other forms of treatment, or to see how an existing drug works on treating a different form of cancer.

And that’s really just the beginning. Clinical investigators are continuing to propose clinical trials to advance cancer treatment in hopes of finding a cure.

 

How To Find a Clinical Trial?

Verdi Oncology is a physician practice and clinical trials management company that solely focuses on partnerships with oncology practices. We connect the expertise and knowledge of physicians with the needs and objectives of patients. Using modern medical science in conjunction with advanced care models, we handle the operational aspects of oncology practice management so our physicians can focus on helping their patients. We bring the promise and science of early-stage clinical trials to where patients live. Contact one of our partner practices today to participate in a clinical trial.

 

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