Every drug prescribed in the United States goes through a strictly regulated process and starts as a 'Investigational New Drug' (IND).
It goes through various early stages of testing to determine if there is valuable pharmacological activity and that it is reasonably safe for use in humans. After animal testing, if it is determined to have viable potential for further development, there will be clinical protocols designed and submitted to the FDA. The FDA reviews these protocols before any clinical trials are undertaken with humans to help assure there isn't unnecessary risk for subjects. 
If the IND makes it through this part of the process there will be a series of clinical research trials involving humans--referred to as Phase I, II and III trials. For INDs that make it through the Phase III trial process, there will be a submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval to market the new medication and allow dispensing by doctors.
Myths about the risks of clinical trials frequently prevent prospective patients from participating in these trials and potentially finding relief from their illnesses.
Here are 4 myths and facts about clinical drug trials:
1. MYTH: Clinical trials are dangerous because the drugs are 'untested'.
FACT: All drugs are tested, and start out as investigational--which means investigators are learning throughout the whole process . The further along in the process a drug is, the more it has been tested and the more evidence there is that it may do what researchers say it can — which is called “efficacy.”
There are four phases for all clinical trials:
- Phase I: Researchers test a new drug or device in a small group of healthy volunteers for the first time to evaluate its safety, determine a safe dosage range, and to check for efficacy.
- Phase II: The drug or device is given to a larger group of people to assess efficacy and safety. This phase determines whether a drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever.
- Phase III: The drug or device is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. This phase determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect.
- Phase IV: Studies are done after the drug or device has been marketed to gather information on the drug's effect in various populations and on any side effects associated with long-term use. [Source: National Library of Medicine]. This phase is also known as post-marketing surveillance trials. Phase IV trials may be required by the regulatory authorities for safety surveillance or by the sponsoring company to find a new market for the drug.
Some clinical trials simply help the pharmaceutical companies and FDA decide if a drug is as good as, or better than, other drugs. Many of the investigational drugs that are in clinical trials here in the US may have already been approved in other countries. They just need additional testing before being approved for use in the United States.
2. MYTH: I might get really sick if I get a placebo.
FACT: Placebos are inactive substances that have absolutely no physical effect on the patient. Their power is only in the patient’s belief, or fear, about the pill or product they’re taking. Some of the investigational drug and product research is comparing placebos against the true medication.
3. MYTH: My body might react badly to the test drug.
FACT: It can be frightening to take a drug that isn’t already on the market, however, you are taking the medication because you have a medical problem that you would like to improve.
In your decision to participate in a clinical trial, you need to assess the potential benefits with the risks of that trial. It is a personal decision for each person to assess the benefits and risks after reading the trial's Informed Consent Form ("ICF") which outlines what is known about the investigational medication.
Nevertheless, there are many different safeguards to reduce the potential for you to get sick. While participating in a clinical trial, there is a chance your condition is being more closely scrutinized than it would be under regular medical care.
In a clinical trial:
- You are closely monitored for side effects throughout the trial.
- If you have issues or feel something different or uncomfortable, clinical trial doctors and staff are available and will respond 24/7 to your concerns.
- “Rescue medications” are often allowed. For instance, if you have asthma and are participating in an asthma trial, there are typically rescue medication inhalers available for you to use at part of the trial.
- All potential patients are highly screened before being accepted into a trial to ensure they are a good candidate for the trial.
- The clinical research staff are monitoring and following the patient very closely to watch for side effects with the participating patient.
If the clinical trial doctor reviews the patients results, (ie: daily or weekly reports, blood tests, EKG readings) and feels that the investigation drug or device is not benefiting the patient, it will be at his/her discretion to remove the patient from the trial, if medically appropriate. The patient safety and welfare is first and foremost in a clinical trial.
4. MYTH: If the study drug helps me, I won't get to keep taking it once the trial is over.
FACT: With some clinical trials, the sponsor may opt to have an open label extension study for that trial. While the investigational drug is submitted for a NDA with the FDA, this open-label extension will allow the subjects who have completed the core trial to continue on the investigational drug if they meet all the inclusion and exclusion criteria while awaiting FDA approval. During the open label extension, all subjects will be exposed to the trial product even if they were assigned to the placebo arm in the core trial. If an open label extension trial is available for that trial, the subject would be informed at the beginning of the core trial.
Clinical Trials
At Chase Medical Research, we are enrolling in clinical trials for a variety of conditions and medications. If you're interested in participating in a clinical trial or are curious if a clinical trial is right for you, don't hesitate to contact us. 
