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What are Clinical Trials?

Clinical Research

What are Clinical Trials?

clinical trials1. The definition of clinical trials

When a medical company needs to evaluate a treatment they use a clinical trial. Clinical trials use volunteers to participate in research, so as to get detailed answers to health matters.

Clinical trials are the best method to find ways to prevent disease, and have proven to be the most suitable way to quickly, and harmlessly find therapies for many different medical conditions.

Different types of clinical trials are used for different studies. Four of the most popular are:

  • finding potential uses for treatments already in use or examining the feasibility of new treatments
  • possibilities for prevention of illness
  • for those with critical health disorders, finding ways to enhance their life experience
  • innovative diagnostic and screening procedures

The protocol for carrying out clinical trials defines the parameters by which the study may be executed. All aspects of the trial are outlined, such as: who will participate, the agenda for procedures and tests, medication and amounts, how long the trial will last and the results that will be calculated. Anyone considered for the study must accept the terms.

2. The reason for conducting clinical trials

There are several reasons why clinical trials are done. The first one that usually comes to mind is the testing of a new drug. This is a very popular reason to do a clinical study. All new drugs and medical devices used to treat human beings have to be checked and passed before they can be released to the general public.

Often, a clinical trial is done to compare one or more treatments already being used to see if there is a difference in their success.

Also, a clinical trial may be done on a standard treatment to see if it can become easier to use or more effective. If a drug has severe side effects, a clinical study may help find a way to reduce discomfort.

Another way clinical trials are used is to test an existing treatment on a different group than for whom it was originally created.

The Food and Drug Administration over sees clinical trials to ensure the safety of all participants. Professional scientists conducting clinical trials will adhere to the guidelines set out by the FDA.

3. Where to look for clinical trials

The US government has a website at clinicaltrials.gov, which is offered by the National Library of Medicine. You can find both private and federally funded clinical studies available for volunteers. It is kept up to date on a regular basis. Everything you need to know about the study is posted on this website, like the reason for the study, and who can apply to participate. There are also contact numbers if you want more information.

4. Available clinical trials

The different available clinical trials include:

  • Prevention trials focus on precluding disease in those never exposed to a particular disease or the possibility of preventing one from returning to someone who has recovered from it. Drugs, alterations in lifestyle, vaccination, vitamins or minerals are all possibilities in these trials.
  • Quality of Life trials (or Supportive Care trials), are used for investigating and assessing different methods of increasingrelief and the quality of life for people with chronic illness.
  • Diagnostic trials are used to uncover improved methods of assessing and identifying a specific illness or disorder
  • Innovative therapies and the possibility of combining medicines or different radiation therapy or surgery practices.
  • Screening trials offer new approaches to finding conditions and diseases.

The most common use of clinical trials is to compare an existing treatment with a newly developed one, to see which treats or inhibits a disease or condition more effectively. There are trials called “blind studies” where each person is given either an accepted treatment or the test product. There are also trials where some participants receive placebos. Because a placebo has no therapeutic value, it is only given in cases where there is no possible danger to those participating, by withholding medication. If a placebo is going to be used the volunteers are told ahead of time. The reason for using placebos is for the immediate observation of the effect of a new treatment.

5. The best candidates for clinical trials

The benefits of clinical trials are numerous. Before a drug or treatment can be released to the public, several tests are conducted. To be sure the product is appropriate for everyone; the FDA warrants a diverse group must be tested. As many age, race, ethnic and gender populations as possible, are included.

When an accepted or standard medical treatment does not function optimally, a patient may decide to participate in a clinical trial. Exposure to the new treatment may offer relief where the standard treatment was unsuccessful. Also, anyone wanting to contribute to the improvement of medicine may volunteer to join a clinical trial.

There are several criteria used to discern who is eligible for a clinical trial. Scientists directing the study will define the study group according to gender, age, disease development and may include previous treatment and any other health issues. Controlling the study group ensures the least amount of variation in the results.

Not all applicants are suitable for every study and will therefore, not be allowed to participate. An applicant may not meet the conditions or the study may only need a defined number of volunteers to meet their requirements.

6. Location of clinical trials

Usually, the sponsor of the study dictates its location. Depending on whom the study is for, i.e. federal agency, private physician, other health care provider or pharmaceutical company, the trial may be held at a clinic, hospital, federal research site, university or other location which can be monitored according to study protocol.

7. Clinical trial safety

Every effort is made to safeguard participants in clinical trials. The FDA has strict regulations and guidelines available here, for the protection of volunteers who choose to join a clinical trial.

Do to the nature of clinical trials there may be unknown risks. Testing a new medical treatment holds a certain amount of risk; however, the government requires that every participant is made aware of all the probabilitiesand the possibility of any unknown results. The role of the FDA is to ensure the participants can make an informed decision as to whether or not they should take part.

Researchers are required to inform potential study subjects about what will happen during the trial. This must contain all the facts as they are known to the researcher. Signing an informed consent, states that the participant fully understands the risks of the study. Also the participant may leave the study at any time. The consent form indicates that there may be unknown results as a consequence of taking part in this medical treatment trial. This information is designed to help the volunteer decide whether or not to participate in a study which may have adverse effects.

8. Things to consider before joining a clinical trial

Before joining a clinical trial you should take a few things into account. Be sure to investigate the study thoroughly. Get in touch with those conducting the trial and speak to the health care team directly so you can address any concerns you have. Find out what the costs will be, if any. And what kind of patient monitoring there is during the study.

Consider the risks and benefits of being a volunteer for clinical trials before you join.

Benefits

Being a participant in a properly designed and executed clinical trial is an effective way for those eligible to:

  • have otherwise unavailable access to specialized medical treatment for the disorder being studied, as researchers are usually experts in the disease area they are studying
  • become an active participant in their own health care
  • contribute to the health care of others by participating in medical research
  • have the ability to try new treatments

Risks

With every clinical trial there are known and unknown risks including:

  • the possibility of no positive effect for the participant
  • some trials are very complex and require extended time commitments, hospital stays, involved dosing procedures and numerous visits to the testing site
  • the possibility of extremely uncomfortable, severe, or life-threatening side effects from using the treatment

Some other things to consider:

Remuneration:

It is not unusual for volunteers to receive payment for contributing their time for a clinical trial. This is called a recruitment incentive. If there is an invasive aspect to the study, or if the participant will receive little or no health benefit from the study, then an incentive is offered. The amount on the incentive may depend on the amount of discomfort and time required to dedicate to the study.
All financial arrangements are discussed and agreed up on at the signing of the informed consent.

Any Conflicts of Interest:

If a healthcare worker or anyone associated with the trial recruits a volunteer and receives payment, this may be seen as a conflict of interest. This information is not usually disclosed, unless the participant asks. It is okay to question the recruiters about their motive for asking you to volunteer, or any other possible conflicts of interest.

Continuing Treatment:

Some researchers will continue treatment, at the conclusion of the study, for those who benefited from the trial. Some discontinue treatment. It will be disclosed at the informed consent signing which is the case.

9. The FDA’s role in new drug and medical treatment approval

FDA staff members will review the data to be studied, the protocol, procedures and the site where the trial is to be held. It is the FDA’s responsibility to ensure the safety of participants involved in clinical trials. The FDA does not conduct clinical trials nor develop new medical treatments.

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