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Welcome to Clinical Research

At Ascada, we're focused on performing high quality research in all fields of human disease. 


What does that mean for you?

A frictionless and gratifying way to participate in clinical research with the peace of mind that you have a team of professionals standing behind you. Let us contribute to medical knowledge while you receive more attention and oversight to your care.

"Why should I do a Clinical Study?"

Pass on the gift of health. Everyday the medical landscape continues to change, and our best tool to tackle it? Each other.


Clinical studies lead the way to better, more effective medication and treatments. Medication such as Tylenol, Advil, and all other medications you see on the shelf today underwent a series of clinical trials to see whether they were safe and effective for you. And these trials are how life-saving treatments are created for patients with previously incurable disease. 


The breakthroughs of today are the treatments that will benefit tomorrow. Take the first step and contribute to research now to protect the health of yourself and others in the future.

A clinical research trial is a necessary step when pharmaceutical companies want to evaluate a new medication, device, or procedure. In order for new medications or medical devices to be approved by the Food and Drug Administration (FDA) for use amongst the public, they must be tested thoroughly. This testing is done through a clinical trial in which volunteers and researchers work to study the safety and effectiveness of a product, under the strict guidelines of the FDA.


Each study follows a strict protocol that outlines who can participate, how much medication will be given, and how the effects will be measured. Every clinical trial is also overseen by a Principal Investigator- a medical doctor trained in clinical research.


At Ascada, our investigators are all Board Certified and work with patients in their own practices. 

"What are clinical trials?"

Different Phases of a Clinical Trial

Learn about how clinical trials progress

Is the treatment safe?

Phase I trials are usually the first trials that involve people. They typically have a small number of participants, who are often healthy, and the primary goal is to determine what dosages are safe and the side effects of the treatment.


The first few people in the study get a very low dose of the treatment and are observed and monitored very closely by medical staff. This allows researchers to see what the drug does to the body, and what the body does with the drug. Safety is always the main concern. 

Does the treatment work?

After a new treatment is found to be safe in phase I clinical trials, a phase II trial is done to see if it works against the disease it is meant to help treat. The trial invovles a larger group of participants, usually around 25-100 people, all with the disease of interest.


Within phase II trials, participants are often randomly assigned to different treatment groups: either the group receiving the medication of interest or a placebo group. The use of a placebo helps researchers determine whether any patients getting better are improving due to the treatment itself, or due to expectations and biases. 

Are results consistent?

Once the treatment has been shown to help the disease of interest, it moves onto phase III trials where the medication continues to be studied to verify it's effectiveness and safety. 


Phase III trials employ thousands of participants to continue evaluation of the overall risks and benefits of the treatment, as well as confirming what was learned in the previous Phase I and Phase II trials.


After Phase III trials are complete, the treatment in question is usually submitted for FDA approval. 

Keeping an eye on it

After the treatment is approved by the FDA, it continues to be monitored for a long period of time in phase IV studies. 


Even after testing a new treatment on thousands of people, all the long-term effects of taking it may not be known. Therefore phase IV trials exist to continue to observe the drug's efficacy and safety in thousands of participants.

FAQ

  • What is Clinical Research?

    A clinical research trial is a necessary step when pharmaceutical companies want to evaluate a new medication, device, or procedure. In order for new medications or medical devices to be approved by the Food and Drug Administration (FDA) for use amongst the public, they must be tested thoroughly.  This testing is done through a clinical trial in which volunteers and researchers work to study the safety and effectiveness of a product, under the strict guidelines of the FDA.


    Each study follows a strict protocol that outlines who can participate, how much medication will be given, and how the effects will be measured. Every clinical trial is also overseen by a Principal Investigator- a medical doctor trained in clinical research.


    At Ascada, our investigators are all Board Certified and work with patients in their own practices. 

  • Do I qualify for a clinical trial?

    Each clinical trial has a set of criteria all participants must meet in order to join. These criteria are created by the sponsor of the study and are meant to ensure that every participant  has the characteristics that the study is interested in.


    To determine if you qualify, please visit our "Join a Study" page and view the qualifications displayed under each study listing, or give our office a call at (657)-214-3679 for us to pre-screen you over the phone. 

  • What is Informed Consent?

    Informed consent is the process in which a designated research staff member educates you about the risks, benefits, and alternatives of a given clinical trial. This must occur before any study procedures start, and is usually documented through signing an informed consent form.  The consent form details what you should expect from participation, any risks or benefits involved, what the main objective of the study is, details about the drug or device, emergency contact information, and more.

     

    Each participant must be competent to make a voluntary decision about whether to undergo participation in a trial, and understand the information being given in the consent form. Participation is always voluntary and consent can be withdrawn at any point of the study process.  

  • Why should I participate in research?

    Clinical studies lead the way to better, more effective medication and treatments. Medication such as Tylenol, Advil, and all other medications you see on the shelf today underwent a series of clinical trials to see whether they were safe and effective for you before being publicly available. And these trials are how life-saving treatments are created for patients with previously incurable disease.  


    The reasons to participate are many: Healthy volunteers do it to help pass on the gift of health to others. And many individuals with disease or illness participate not only to help research, but to possibly receive the latest treatments for their condition as well as close medical oversight from the study doctors. Participation can be as involved as taken new medication, or as casual as donating a urine, blood, or nasal swab sample. 


    The breakthroughs of today are the treatments that will benefit tomorrow. Take the first step and contribute to research now to protect the health of yourself and others in the future.

  • How is my information being protected

    All clinical trials are overseen by the FDA who ensure that they are being run according to federal law and good clinical practice (GCP) regulations. 


    This includes following the prinicipal of HIPAA privacy guidelines which protects the privacy of individually identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct vital research. Therefore any information shared between the site and the sponsor for research purposes will not contain any personal identifying information unless prior authorized by you. This means that information such as your name, date of birth, address, phone number, etc. is not provided to the sponsor or any other entity unless authorization is obtained. 


    During participation, you might be given a 'Medical Information Use and Disclosure Authorization' form that allows a covered entity to use or disclose your protected health information for the purpose(s) and to the recipient(s) stated in the Authorization. When an Authorization is obtained for research purposes, the Privacy Rule requires that it pertain only to a specific research study, not to future, unspecified projects. If an Authorization for research is obtained, a covered entity's uses and disclosures must be consistent with what is stated in the Authorization.