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Experimental Drug Trials - International Nurses Association



If it were not for drug trials, many of the lifesaving drugs we all use might not be available today.  Obviously, drug trials are important for the development of medicines, but anyone that is entering a trial needs to be well informed.  Never encourage anyone to enter a clinical trial for financial compensation only, as trials should be to benefit medicines and medical technology. 

What exactly is a Clinical Trial?

Clinical trials may also be referred to as clinical studies.  In a clinical trial, human volunteers agree to be tested using potential treatments to determine if they should be approved for use in the general population.  Treatments can consist of drugs, medical devices, vaccine, blood product, or gene therapy.  All treatments have prior studies in animals to learn of potential toxicity, and have been approved for human trial.  The FDA assures the public; they are protecting the participants in any trial, and provides all pertinent information to the participant.  Over the years there have been allegations against drug trial companies regarding the participants' safety, and there are currently petitions requesting the government regulate all drug trials.  Although many safety measures are put in place to protect volunteers, it is still a drug “trial” and all side effects are not known.  Anyone that chooses to participate in a drug trial should read all paperwork carefully, and weigh the possible risks to their own health. 

Why Volunteer for a Trial?

Most people participate in drug trials because it may offer hope for their medical condition.  For someone that has suffered from a condition for a prolonged period of time, with little or no relief, it's easy to understand why they would take their chances with a trial.  Others may participate for the good of a family member or loved one, in hopes of benefiting them with a medical condition affecting their life.  Then there are some people that sign up for drug trials for financial compensation.  All too often, people that sign up for financial reasons may not read all warnings regarding the trial.  This is generally when problems arise; a reasonably healthy person may now suffer from complications as a result of the drug trial.  Patients that enroll in drug trials for finances should be encouraged to carefully study all side effects and risks.  There is a need for clinical trials, and it is important to test medical products within the group of people they are intended to help. 


How do Clinical Trials Work?

All trials are orchestrated to answer certain questions.  Studies are most often blind, and a participant does not know if they are receiving the actual drug, or a placebo.  The FDA offers technical support to the researchers conducting the trial.  Clinical trial teams include doctors, nurses, and other needed health care professionals.  The team will monitor the health of every participant and closely track their progress with the medications administered.  Trials are conducted in phases, with phase 1, determining dosing, and to document how the drug is metabolized and tolerated.  Phase 2 trials are meant to include participants that have the medical condition, and to determine the drug's effectiveness on their condition.  If phase 2 participants do well with no significant side effects, the drug moves forward to phase3.  The phase 3 drug trials test more people and continue to monitor the effectiveness and side effects.  If phase 3 trials are acceptable the drug moves forward to phase 4.  This trial is conducted after the product is approved and on the market.  Phase 4 continues to monitor the drug for side effects and success in treating the medical condition.  This is also where long term side effects are noted, as well, as the long term success of the drug. 

There are guidelines that are followed in drug trials, no children unless special circumstances prevail.  As for each person receiving the same drug, that does not happen, some will receive a placebo.  Studies are very controlled, and there is no way for participants to know which drug they are receiving.  Side effects can be mild, moderate and even severe.  If severe side effects occur in multiple participants, the trial is stopped.  The risks depend on the drug, and the health of the individual in the trial.  There are regulations in place to protect participants, however many feel they are not strict enough. 

Locations of Clinical Trials

Clinical trials can take place in hospitals or in a specialized clinic.  For trials that involve overnight stays, patients are made to feel at home. The atmosphere is very relaxed and they have tv's, computers, recreational activities, all the comforts of home.  When the companies conducting the trial find someone that meets the criteria. They want to do all they can to keep them comfortable so they they remain for the duration of the study. 

Clinical drug trials have their place in society, and there is a need for them as well.  Without clinical trials, many drugs would be in limbo and not readily available for those who need and would benefit from them.  AIDS medications have saved countless lives, and it happens to be one of the more known drugs that advanced to phase 4 quickly, due to the trials and the number of participants.  Clinical trials are expected to grow in the future as new medical technology expands.  Participants should pay close attention and gather all information related to the trial.  After reading about all potential side effects a participant can then make an educated decision on participating in the trial, safety should always be the first concern. 

A special thank you and consideration is given to all of the people that have participated in clinical drug trials in order to expedite the approval of life saving drugs.  Today's testing may very well save life tomorrow, or make a life worth living.  Volunteering to participate in a clinical drug trial is certainly a way of contributing to society.  Volunteers should enter any study with a complete understanding of the drug trial, which will assure safety, as the drug being tested can move forward to benefit others. 


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