Protecting Your Rights As A Medical Study Volunteer

You may be hesitant to volunteer for a medical study because you are not sure if the researcher from the medical research team can be trusted. To protect your rights, the National Research Act was passed in 1974. This act led to the establishment of Institutional Review Boards (IRBs). IRBs exist to protect the rights of trial participants. An IRB is a group that consists of people such as doctors, lawyers, community members, and members of the clergy.

In order to run a clinical trial at a hospital, clinic or private doctor’s office, the research investigator must submit an application to the IRB at that site or to a central IRB. The application contains detailed information about the clinical trial. The IRB reviews the application to make sure that the trial asks a worthwhile scientific question and that the trial design is ethical.

IRBs also review the safety monitoring of the trial. Researchers are required to submit regular reports about the progress of the trials and to inform the IRB about any side effects that trial participants experience.

The Purpose Of Clinical Trials

Though there are currently Food and Drug Administration (FDA) approved to treat patients with a broad spectrum of conditions, clinical trials are still extremely important. Researchers are working on providing patients with additional treatment options as well as developing medications with fewer side effects and easier treatment regimens. All of these experimental treatments must be tested for safety and effectiveness. Without participants in these trials, progress in understanding and treating diseases is impossible. Historically, study participants have been primarily white males. Women, people of various ethnicities and races, as well as other populations have been under-represented in clinical research. In order to better advance treatment, all populations must be represented in clinical trials.

In order for any medication to be approved by the FDA and placed on the market, it must be tested on humans in clinical trials. Clinical Trials show if a medication is effective in treating and/or reducing symptoms and if it is safe. There are different kinds of medication trials. Some examples are: testing a single experimental medication, evaluating different combinations of approved medications, and examining a combination of approved and experimental medications.

Possible Benefits Of Participating In A Clinical Trial

1) Access to the medications that are not FDA approved.

You may have already tried every available medication for your condition. The medication under investigation may be effective in treating the symptoms or condition you have, though there is no guarantee that you will benefit. If you are already on a medication that you like, it is probably not advisable to switch to a new medication. Discuss your decision to participate in a study with your family and doctor.

2) Increased Care

You may receive your regular care in a large clinic or see a health care provider with many patients. As a result, you may not have as much one-on-one time with your healthcare provider as you would like. When you get involved in a clinical trial, you develop a relationship with the research team (the investigator, study coordinators, therapists, and nurses running the trial.) You may benefit from having more health professionals involved in your care. The research team can be a great resource for questions about your diagnosis.

 

Clinical Trial Phases and Stages

When a new medication is developed, the process starts in a test tube and then progresses to animal studies. If the results of early studies look promising, clinical trials are conducted to test the medication. Medication trials are divided into phases. When phases I, II, and III are complete, the information from the trials are submitted to the FDA. The FDA reviews all the information, and they may approve, reject, or ask for additional new medication.

In order for any medication to be approved by the FDA and placed on the market, it must be tested on humans in clinical trials. Clinical Trials show if a medication is effective in treating and/or reducing symptoms and if it is safe. There are different kinds of medication trials. Some examples are: testing a single experimental medication, evaluating different combinations of approved medications, and examining a combination of approved and experimental medications.

There are many reasons to think about joining a clinical trial. When deciding whether or not a trial is right for you, consider some of the benefits and risks.

Questions To Ask Before Joining A Clinical Trial

Here is a list of questions you should ask before joining a clinical trial:

  • How often do I have to visit the study site and how long will each visit take?
  • What should I do If I miss an appointment?
  • What should I do if I get sick or experience side effects while participating in the study?
  • Does the informed consent form list all the risks and benefits?
  • Can I participate in therapy while I’m in the trial?
  • Will I get any compensation for participating in the trial?
  • Will I need to return to the site once the trial is over?
  • How can I find the results of the trial?
  • What alternative therapies are available?
  • Can I take nonprescription (over-the-counter) drugs or complementary therapies while I’m in this trial?
  • Can I use prescription drugs while I am participating in clinical trials?
  • Can I take other experimental drugs?
  • Will the lab tests cost me anything?
  • Will I get the results of these tests?
  • Will I get the study drug once the trials are over?
  • What should I do if I miss a dose of my drug?
  • What are the possible immediate and long-term side effects of this drug?

If you have any more questions about clinical trials, need answers to the questions listed above, or are interested in participating please contact Maria Cano at (305) 871-7010 or email her at columbusclinical@bellsouth.net.

 

Hispanics Participation In Medical Research In Miami

The Hispanic people participating in medical research in Miami and across the country is small in comparison to the rest of the population. Why are Hispanics and other minority groups under-represented in research studies on new medications? Patients who have the same language and cultural background as their physicians are more trusting and likely to participate in clinical trials. There are fewer Hispanic physicians and even less who conduct clinical trials. This results in fewer patients being offered the opportunity to participate in clinical trials.

Medical research in Miami, Florida can provide information on how a drug is metabolized in the body. The information will tell how effective the drug is and if there are any side effects in the Hispanics that would otherwise not be detected. It is important to include patients of all races and ethnic backgrounds in clinical trials in order to evaluate a drug’s effectiveness and safety. There is not a one-size-fits-all drug for patients which is why there are so many different drugs for the same disease.  More than 50 medications are available by prescription to treat high blood pressure (hypertension). Physicians must consider many factors before prescribing the right medication for a patient. There are hundreds of clinical trials being conducted in Miami hospitals, universities and community doctor’s offices. There are research centers such as Columbus Clinical Services where doctors focus entirely on conducting clinical trials on many new drugs for medical problems.

Patients who are taking responsibility for their health are searching the internet for information on treatments available for their medical problems. Patients who speak Spanish as their primary language adds a  layer of complexity. The research staff must be fluent in Spanish in order for the patient to fully understand what is involved in a clinical trial and be able to give fully informed consent. These and other issues impact the number of patients who are enrolled and retained in medical research studies. These issues must be addressed by patients and medical research teams in Miami, FL and other cities in the US. Implementing new plans may offer solutions to increasing the number of patients in Hispanic communities who participate in clinical trials.

Clinical Trials That Columbus Clinical Services Are Currently Enrolling

We are currently enrolling patients in a clinical trial for Chronic Constipation. What is constipation? People who have less that 3 bowel movements a week have constipation. If the constipation lasts 3 or more months, it is considered chronic. Most people have a bowel once a day, but is not abnormal if  skipped a day or two. Symptoms of constipation may be hard stools, causing straining to pass. Many people don’t consider chronic constipation serious and don’t seek treatment. It is not necessary to suffer from symptoms of constipation. A study on a new drug for chronic constipation is being conducted at Columbus Clinical Services. Patients who qualify will receive medical care and the study drug at no cost. Compensation for time and travel will be paid.

We are currently enrolling patients in a study for Asthma. What is asthma? It is a common disorder that causes inflammation and narrowing of the airways, causing shortening of breath, chest tightness, cough and wheezing. Although severe cases may result in death, most patients will respond well to treatment. Columbus Clinical Services is enrolling patients in a study comparing 2 marketed medications to evaluate any negative outcomes. Patients who qualify will receive medical care and medication at no cost and will receive compensation for time and travel.

Columbus Clinical Services will be enrolling patients in new studies on pain, ankle sprain, diabetes, HIV and Hepatitis C. Patients who sign up on the Columbus Clinical Services website, will be notified of enrolling and upcoming studies.

Columbus Clinical Services Attends ACRP Global Conference

Maria Cano, RN, Director of Clinical Operations attended the Association of Clinical Research Professionals Global Conference in Houston, Texas April 14-16, 2012. Attendees obtain the most current information on the clinical research industry as well as professional development with workshops on regulatory compliance and how to conduct a successful clinical trial. Maria said “Attending industry conferences keeps Columbus Clinical Services on the cutting-edge of clinical research.”

Columbus Clinical Services LLC

Welcome to our website! This is our first blog post so we would like to take this opportunity to thank you for visiting our website and hope that you will find it both helpful and enlightening. We designed the site to make it easier than ever to find information about clinical trials that is important to you, your family, and your friends.

You can use links on this site for a variety of purposes, from learning about clinical trials to finding one that that we are currently enrolling patients in. If you don’t find what you are looking for on our website, please contact us at columbusclinical@bellsouth.net  or call (305) 871-7010. Thank you for visiting our website.  I hope you like it and that you’ll return often.