Background Insight on Clinical Trials


The process of bringing a new drug to the consumer marketplace requires extensive clinical trials. Rather than just one singular process, clinical trials are actually a series of distinctive studies that seek to gain different levels of understanding on the efficacy and impact of new drugs developed to fight a range of diseases.

Exploring Clinical Trials

“Clinical trials” is actually a broad term used to describe any number of studies or research efforts designed to test the impact of new drugs. Types of clinical trials include, but are not limited to the following, according to the University of Utah:

  • Prevention: test new approaches using medications or supplements that doctors believe may lower the risk for cancer.
  • Diagnostic: study procedure that could be used to more accurately identify cancer.
  • Genetics: focusing on the genetic makeup and how it can impact detection, diagnosis, treatment of and the body’s response to cancer.
  • Treatment: evaluate the effectiveness of new drugs or new approaches to the use of current drugs/treatment programs.response

Phases of Clinical Trials

Each of these types of clinical trials goes through a number of phases, and these must be completed in order during the process of bringing a new drug or modified treatment to market. These steps include:

  • Phase I trials: these are first-time tests of new drugs or treatments on human patients. The focus is usually on developing a sense of the drug’s effectiveness, best dosage, and potential side effects.
  • Phase II trials: the second step can only be taken once the proper dosage has been identified in the previous step. This step focuses more intensely on the effectiveness of treating a particular disease.
  • Phase III trials: With dosage and effectiveness determined, it is now time to test the effectiveness of the new drug compared to standard treatments already available.
  • Phase IV trials: focuses on evaluating the long-term safety and effectiveness of the new treatment.

Drugs Currently in Clinical Trials

As noted by Fortune in October 2015, the United Kingdom is currently in the midst of the world’s largest clinical trial, and its focus is on an amazingly common drug used by billions of people each day. Some 11,000 people in the United Kingdom with early-stage cancer are participating in a clinical trial to see if a daily dosage of aspirin can actually prevent a recurrence of cancer in those who have already had cancer previously.

Meanwhile, CytoDyn Inc. is testing a new drug designed to fight off HIV in a Phase III clinical trial. The injections of PRO 140 can be given to the patient, by the patient, and the new antibody is showing early signs of success compared to other approved drugs in the market for HIV. The company is hoping to earn fast-track approval from the Food & Drug Administration (FDA) with a successful Phase III trial.

Trouble in Clinical Trials

Progress rarely comes without setbacks, and clinical trials are no exception to this rule. Zafgen Inc. is a Boston-based biotech company whose promising new drug candidate to treat obesity and metabolic disorders had a recent clinical trial rocked by controversy. A patient participating in the trial died during the course of the late-stage clinical trial. The individual’s cause of death remains unknown.

However, clinical trials are usually considered relatively safe because of the large amount of oversight from institutional review boards (IRBs) and government agencies.

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