10 Things You Should Know Before Signing Up for a Clinical Trial
Over the past decade the variety and effectiveness of treatments for psoriasis has increased tremendously. We have gone from topicals that address the condition's symptoms to, for example, drugs such as biologics that target the cause. This means that opportunities for clinical trials have increased as well.
Still, there are many things to consider before signing up to take part in a study. Below, Clincial Researcher and Dermatologist Dr. Jonathan Weiss of Gwinnett Dermatology in Snellville, Georgia, weighs in on the pros and cons on being part of a clinical trial.
First: The Approval Process
The Food and Drug Administration advises that there are four phases for clinical trials before approval, including:
1.** A small group of patients are chosen to participate.** The purpose here is to study safety and dosage. This usually lasts a few months.
2. At least 100 people are chosen to participate. The purpose of this phase is to monitor efficiency and effectiveness of drug. This can last a few months to two years.
3. 300 to 3,000 patients are recruited. Here, researchers continue to monitor efficiency, but also record adverse effects.
4. Several thousand patients volunteer. Researchers continue to test for safety and efficiency.
Once a clinical trial is completed, the sponsor for the study must submit an Investigational Drug Application to the FDA, which requires data on a variety of aspects of the drug. The FDA then has 30 days to review material and decide on approval or rejection of the drug.
How are patients recruited?
Dr. Weiss notes that researchers often use traditional methods in order to find participants: “Advertising through mass media, the internet, television, radio, and newspapers," are common ways of locating potential patients. "There is also a company that has collected a database of names, and they can get us patients, as well.”
How can a patient find clinical trial opportunities?
Those interested in taking part in a clinical trial can reach out to a few different places:
- The sponsor for the study (usually a pharmaceutical company)
- A non-profit or advocacy group that caters to the disease, e.g., The National Psoriasis Foundation
How are participants selected?
Patients are chosen based on the state of their disease, by the symptoms they experience, or the severity of the condition. According to Dr. Weiss, criteria for the clinical trials are determined by the sponsoring pharmaceutical company and the FDA.
How long do clinical trials last? The length of a clinical trial varies and depends on the drug. According to Dr. Weiss, the initial trial for a drug lasts about 12 weeks, but could go longer depending on the study requirements.
“[Frequently] these days, researchers are conducting long-term, open-label extensions, especially on people who have psoriasis where not all people [in the study] are receiving an active drug. After 12 to 16 weeks the groups get re-randomized.” This means that the persons in the study may have their dose increased, decreased, or they'll taken off a placebo and given the actual drug.
How will clinical trials affect a patient's family?
Participating in a study is definitely something that involves the entire family. There are restrictions that people have to consider before participating. Women who are considering entering a study cannot get pregnant during this time and have to engage in birth control in order to ensure that pregnancy does not occur. “That’s to protect the fetus, not to discriminate against women,” Dr. Weiss observes. Due to possible restrictions that could affect a spouse or kids, participation in a study is something that should be discussed with immediate family members. ow often does a person have to have lab work done?** **
“This depends on the trial and the medication under study," says Dr. Weiss. For drugs that don’t usually involve significant risk, such as topicials (which are applied to the skin), lab work may be required a few times during the study. For more serious drugs such as biologics, weekly or monthly visits may be required. This is something to consider before signing up. Here are some questions to ask before committing to a trial:
How will this affect my job? (Will you have to leave work early each week?)
How will this affect my family? (Will you have to adjust family members' schedules?)
How will this affect my budget, e.g., transportation expenses to and from the doctor?
What are the pros of being part of a clinical trial?
- Having access to a highly effective drug before it reaches the general public. (Depending, of course, on whether or not the drug actually works.)
- Those without insurance or who can’t afford medicine have a great opportunity to try a drug at no cost with free medical supervision.
- Dr. Weiss advises that patients are more likely to use the medicine in the correct way, because they're being monitored so closely by doctors.
- Participants are paid for the study.
What are the cons of taking part in a clinical trial?
- An increased time commitment.
- Participant might receive a placebo, rather than active medicine, meaning the patient may not get better.
What happens when the clinical trial is over?
A concern for many patients is what will happen with their treatment after a clinical trial is over. A good clinical research team will make sure patients receive continued treatment in a few ways.
"We try to get the patient in the system for approval of the medication by their insurance company,” says Dr. Weiss. He also states that some companies will allow continued use at a very affordable cost for two years after the trial is over. Dr. Weiss also stresses that it’s important for a patient to have a solid relationship with his or her doctor, and the patient should take an initiative on following up about options for continued treatment. "It’s a cooperative relationship between the patient and the physician," Dr. Weiss says.
Alisha Bridges has battled with severe psoriasis for over 20 years and is the face behind _ Being Me in My Own Skin, a blog which highlights her life with psoriasis. Her goals are to create empathy and compassion for those who are least understood, through transparency of self, patient advocacy, and healthcare. She is currently a post-bach student at Georgia State University pursuing a career as a Physician's Assistance—her passions are dermatology and sexual health. Alisha also shares her passion as a Social Ambassador of the Psoriasis HealthCentral Facebook page where she shares timely tips, stories and insights on living with psoriasis. You can also find Alisha on Twitter._