Chances are you’ve seen one of these ads in your local newspaper or on television: “Do you suffer from (insert common medical condition here)? Would you like to participate in a research study to evaluate a new treatment?” Many people are curious about such studies but hesitate to take the next step.
Nothing obligates you to join a study, but it’s an option worth examining. “If you participate in a study, you’ll be advancing scientific knowledge to help the next patient like you. In fact, you’ve already benefited from all the people who took part in earlier clinical research,” says Harvard professor Dr. Christopher Cannon, executive director of Cardiometabolic Trials at the Harvard Clinical Research Institute.
Types of studies
One of the most famous studies is the long-running Framingham Heart Study, which has yielded a wealth of information about the causes of heart disease and stroke. It’s an example of a cohort study, which follows a large group of people over a long period of time. Through questionnaires or interviews, researchers gather information on a wide range of things—diet, exercise, and medical and family history, for example. They may also measure different variables (such as blood pressure or cholesterol level) or do other testing to assess a person’s health status.
A clinical trial is type of study in which volunteers receive a new treatment, which may be a medication, a procedure, or a device. Most often, volunteers are randomly assigned to receive either the investigational treatment or the comparison, which may be a placebo (an inactive therapy) or a treatment that’s already available.
All clinical trials have very specific guidelines about who can participate. Some seek healthy participants, while others require people with a specific condition or illness. Researchers also use a variety of criteria—including age, blood test results, and other medical conditions—to include or exclude people from a trial. This helps protect the participants’ safety and ensures the investigators get the information they need.
Safeguards in place
Anyone who volunteers for a research study must undergo a process known as informed consent, which is designed to help them clearly understand what to expect as well as the risks and benefits of participating. An independent committee known as an Institutional Review Board ensures the study is performed in a way that protects the rights and welfare of the participants.
In addition, the FDA reviews proposed studies of new drugs or devices and approves only those for which they deem the potential benefit is greater than the possible risk, Dr. Cannon explains. Still, there can be unforeseen side effects from any experimental treatment, and they can be unpleasant, serious, or even life-threatening. Another possible downside is the inconvenience, as the study may require extra clinic visits and complex treatment regimens.
On the other hand, the extra medical attention—which is in addition to your usual care—may be helpful, because any changes in your health are more likely to be noticed. Another potential advantage is access to new therapies before they are widely available or affordable, although in any clinical trial, you won’t know if you get the new treatment or not, notes Dr. Cannon.
For more information
If you’re considering joining a clinical trial, your doctor may be able to steer you to a study appropriate for your condition. The National Library of Medicine maintains a current list of public and privately supported clinical trials at www.clinicaltrials.gov where you can search by condition, location, and other criteria.
Before signing up for a study, carefully read the informed consent form and be sure to get answers to these questions:
- Are there alternative treatments other than the one being tested in the trial?
- How will you monitor my safety during the trial?
- After the trial ends, can I opt to stay on (or switch to) the treatment being tested if it proves successful?
- What happens if I am harmed by the trial?
Related Information: Harvard Heart Letter
Below are spiritual recipe for health and wellness: Matthew E. McLaren
Whoever would foster love covers over an offense, but whoever repeats the matter separates close friends. Proverbs 17:9 NIV
Be kind and compassionate to one another, forgiving each other, just as in Christ God forgave you. Ephesians 4:32 NIV
For if you forgive other people when they sin against you, your heavenly Father will also forgive you. Matthew 6:14 NIV
Bear with each other and forgive one another if any of you has a grievance against someone. Forgive as the Lord forgave you. Colossians 3:13 NIV
If my people, who are called by my name, will humble themselves and pray and seek my face and turn from their wicked ways, then I will hear from heaven, and I will forgive their sin and will heal their land.
2 Chronicles 7:14 NIV
Do not judge, and you will not be judged. Do not condemn, and you will not be condemned. Forgive, and you will be forgiven. Luke 6:37 NIV
Who is a God like you, who pardons sin and forgives the transgression of the remnant of his inheritance?
You do not stay angry forever but delight to show mercy. Micah 7:18 NIV
You, Lord, are forgiving and good, abounding in love to all who call to you. Psalm 86:5 NIV
Therefore, my friends, I want you to know that through Jesus the forgiveness of sins is proclaimed to you. Through him everyone who believes is set free from every sin, a justification you were not able to obtain under the law of Moses. Acts 13:38-39 NIV
He is the atoning sacrifice for our sins, and not only for ours but also for the sins of the whole world.
1 John 2:2 NIV
Whoever conceals their sins does not prosper, but the one who confesses and renounces them finds mercy. Proverbs 28:13 NIV
In him we have redemption through his blood, the forgiveness of sins, in accordance with the riches of God’s grace. Ephesians 1:7 NIV
Rend your heart and not your garments. Return to the Lord your God, for he is gracious and compassionate, slow to anger and abounding in love, and he relents from sending calamity. Joel 2:13 NIV
Peter replied, “Repent and be baptized, every one of you, in the name of Jesus Christ for the forgiveness of your sins. And you will receive the gift of the Holy Spirit.” Acts 2:38 NIV
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