Everything to Know Before Participating in Human Medicine Testing

Mar 9, 2015 by

Research and development of medicinal drugs are costly but essential for mankind. Human testing of the new drugs is required in order to prove them safe and effective for the general population. When somebody decides to volunteer for the human medical testing, he or she doesn’t only make a contribution for the greater good of the community, but also gets compensated for the time and effort that invested. Although volunteering for human medical testing is a noble cause, still it is important that a volunteer understands everything about the process, and what to be expected from the testing and trials.


Image: flickr.com/photos/proimos

What Is Human Medicine Testing

Human medicine testing is a method of research where volunteers are given medicinal drugs under the close supervision of research professionals and Food and Drug Administration or FDA. Pharmaceutical and biotechnology companies select investigators, who then develop new medicines and conduct testing of the medicine on humans in order to find out the advantages of the drugs under investigation. Human medical testing is generally conducted in four phases. The numbers of volunteers required for each of the phases increases as the research moves from one phase to the next.

Different Phases of Human Medicine Testing

Phase 1: This initial phase of testing assesses the safety of drug. In this phase, a study is made to determine the effects and the side effects of the drug on the human body. The test is done on a small number of volunteers who are paid to undergo the clinical trials. About 70% of experimental drugs pass this phase of testing. The study determines the effects of the drug on patients, including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that may result from the varying dosage levels.

Phase 2: Once the dose or range of doses is determined, the next step is to evaluate the efficacy of a drug or device. This phase of testing may last from several months to two years, and involves several hundred patients. Sometimes the development process for a new drug fails. This usually occurs during Phase 2 trials when the drug does not work according to expectations or has a toxic effect. This phase of study generally involves two groups. One group of patients receives the experimental drug, while a second control group receives a standard treatment or placebo. This allows the researchers to come up with comparative information about the relative safety and effectiveness of the new drugs.

Phase 3: The studies around this phase are used to establish the value of the drug in clinical phases. This phase requires the involvement of several hundred to several thousands of patients to perform large scale testing. One of the most common practices is to continue the Phase 3 testing even when regulatory submission is pending at the appropriate regulatory agency. About 70-90% of drugs that enter the Phase 3 are likely to be successful. It is only after this phase that the pharmaceutical company can request FDA approval for marketing the drug. This step is useful in obtaining additional safety data and support information to make a claim for the drug use.

Phase 4: A Phase 4 study, popularly known as Post Marketing Surveillance Trials, is conducted after the drug has been approved for consumer sale. The study involved in this phase mainly concentrates on comparing the drug with other drugs that are already available in the market, and marking their effectiveness against similar products. The entire process during this phase may take up to several years to complete, often costing millions of dollars. If any harmful effects are being inferred at this stage, the drug may be taken out of the market or may be sold with restrictions of use.

Who Can Participate in Human Medicine Testing

Not everybody can qualify for participating as a test subject in the research of a particular type of medicine. Listed under the “inclusion criteria” there are several factors that determine the types of volunteers required for the trial. There is also a separate list called “exclusion criteria” that has the list of factors that can disallow a volunteer’s participation. Some of common criteria include:

  • Age
  • Gender
  • Type of a disease
  • Stage of that disease
  • Medical history
  • Treatment history
  • Any other medical condition

What Happens in Human Medicine Testing?

Generally, during the study volunteers are divided into two groups. One study group gets the new medicine, for which the test is being done. Another group receives a placebo, a kind of inactive drug or a drug that is already being used. Nobody among the participants, physician or the research staff, knows which volunteer has received a placebo and which has got the actual medicine. All the methods and medical care that these volunteers get are same. Physician and research staff then objectively study the volunteers.

What Questions to Ask Before Participating

Here is a list of some of the basic questions, a volunteer should ask before making a decision to participate in the human medicine test.

  • What is the duration of the test
  • What is the location of the trial
  • What kind of medicines will a participant get
  • What are the objectives and goals of the test
  • What are the risks involved in the study
  • What are the safety parameters that would be observed
  • What are the advantages of the study
  • Details of the alternative medicines that might be used along with the medicine being researched
  • If there is any option available to be on the medicines, even when the test is done
  • Who are the sponsors of the medicinal test that will be carried out
  • What compensation one can expect from participating in the trials
  • If harmed, what steps would be taken

What to Expect as a Volunteer

Generally volunteers get a physical examination before the testing. The physician or a research staff might also review their medical histories. The health and safety of the volunteer are monitored during and even after the human testing of the medicine is done. Specific instructions are generally printed in the consent forms along with the other information.

Quintilesclinicaltrials.co.uk is one place where volunteers can expect to participate in human medicine testing in a safe and healthy environment while being paid for their time and any inconvenience caused to them.

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