Much of the news recently has been about clinical trials, I have had many people ask me what clinical trials are and what does all of this mean. I thought it was time to put together a brief overview about clinical trials.

WHAT IS A CLINICAL TRIAL?

A clinical study uses people, human volunteers (also called participants) to do research on.

There are three main types of clinical studies: the first is called a clinical trials. This is a prospective study meaning it goes forward in time. It can also be called an interventional study. The second kind of trial is an observational trial (or study) and the third is a retrospective study. Let’s discuss the differences among these different types of studies.

In an interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions could be medical devices; procedures; drugs or changes to your behavior. Some examples to each of these are a new type of heart valve, a new method to administer a drug, a new drug to treat hypertension (high blood pressure) or a new technique to lose weight which could be a dietary modification behavior chance study.  In an interventional study (or a clinical trial), we usually compare this new medical approach to a STANDARD one that is already available, OR to a PLACEBO, or to another intervention. This comparison is what allows us to determine if this new method is more (or less) effective than what is currently available.

In an observational study, Investigators JUST observe certain characteristics of people usually for a very long time to measure the outcomes on certain populations. For example, There Is a classic observational study titled the Framingham heart study designed to understand cardiac disease development in a specific populations.

In a retrospective study, we look back in time. This is usually just a collection of data that has been previously collected by an academic institution, or a hospital, of a government agency. We DO NOT know who the people are and that means the data is “de-identified”. Information from this kind of study helps the research community to see “trends” in peoples’ health and develop research ideas from that.

WHY DO WE DO CLINICAL TRIALS?

The textbook definition is that we want to add to our medical body of knowledge. But what does that mean to you the person who is volunteering to be in in that clinical trial? More details

You see, the more we learn about diseases and conditions and how drugs, devices, even behavior changes help or don’t help that condition we learn something, and we keep refining this learning process so we can manage peoples’ health better.

WHO CONDUCTS CLINICAL TRIALS?

Every clinical trial has a principal investigator which is typically a medical doctor.

And a trial is sponsored by someone or some organization which is often a pharmaceutical company, a medical device company even volunteer groups foundations the federal government.

WHERE DO WE DO CLINICAL TRIALS?

Clinical studies can take place in many locations, including hospitals, universities, doctors’ offices, and community clinics. They can be local, or a state-wide trial, regionally, nationally, and absolutely internationally. This all depends upon the hypothesis (also known as the objectives) of a particular study.

HOW LONG DO CLINICAL TRIALS LAST?

The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll. Some typical reasons to determine the length are:

  • How many interventions are being studies – another way of saying this how many different drugs, or therapies are being studied?
  • Is the study about prevention or recurrence of a disease or condition.
  • Are we trying to identify or diagnosing a particular disease or condition
  • Searching for risk factors for that condition
  • An important one is measuring ways to improve the comfort and quality of life.

WHAT IS A PROTOCOL?

IN THE SIMPLEST SENSE…….IT’S A RECIPE

A clinical study is conducted according to a research plan known as the protocol, THE RECIPE. And the protocol is designed to answer specific research questions and safeguard the health of participants. Another example may be if a new high blood pressure drug works better and is safe when compared to what is currently being prescribed.

WHAT GOES IN A PROTOCOL? A protocol is very detailed and some of the key components are:

  • The reason for conducting the study
  • Who may participate in the study (the eligibility criteria)
  • The number of participants needed
  • The schedule of tests, procedures, or drugs and their dosages (which is how much of the drug you are to get)
  • The length of the study
  • What information will be gathered about the participants

HOW AM I PROTECTED?

This question should always be asked because a clinical trial does have risks associated with it. And it is important for you to know these risks. The informed consent document is intended to protect you, and it should provide enough information for you to understand the risks of, potential benefits of, and alternatives to the study.

IN addition to the INFORMED CONSENT every clinical trial is approved by an INSTITUTIONAL REVIEW BOARD. It is often referred to as an IRB. An IRB is a group of people, made up of doctors, researchers, and members of the community. They review the informed consent document making sure that the study is ethical and that the rights and welfare of participants are protected.

WHO CAN BE IN OR PARTICIPATE IN A CLINICAL TRIAL?

Clinical trials are open to volunteers, however there are very specific restrictions prohibit certain populations from being studied. To determine who can participate in a clinical trial the protocol will list very SPECIFIC illnesses or conditions that will be studied. An example of this may be that a high blood pressure clinical trial is looking for people that have a Systolic blood pressure between 140-149 mm/Hg Some clinical trials do ask for healthy participants too.

There is an extensive Eligibility criteria for each study and it is listed in the protocol. This eligibility criteria is further categorized into INCLUSION and EXCLUSION CRITERIA.

HOW DO I BECOME INVOLVED IN A CLINICAL TRIAL?

The way that you determine if you are eligible for a study is that you go through a screening process after and only after you sign an informed consent.

There are certain exclusion criteria that could keep you from being eligible. This is all dependent upon what we are trying to study.

WHAT ABOUT MY REGULAR DOCTOR?

You should always continue to see your usual health care providers while enrolled in a clinical study because a clinical trial does not provide extended or complete health care. Also, you want to be sure that your physician is aware of the clinical trial so he/she can determine that there are no conflicts with any of your other medications or treatments that you may be receiving.

HOW DO I CONSENT?

Before you begin the clinical trial process you must sign an informed consent document. This is to show that you were given the information on the risks, potential benefits, and alternatives and that you understand this. By signing the document and providing consent it is not a contract and you may withdraw from a study at any time, even if the study is not over.

WHAT ARE THE BENEFITS?

This is a personal decision. You should consider discussing your participation on a clinical trial with your loved ones, particularly if you will need their assistance during the clinical trial. You should also discuss this with your doctor. In the end, it is your personal right and decision. Take your time to read the informed consent and think about it. Ask questions. Be sure you understand your role fully. There are Pros and Cons to everything we do, and this is no different for a clinical trial.

By breaking it down – a PRO may be that your participation can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. And a CON may be that most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. Remember 1 thing

This is your decision.

~Brains Matter

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