Frequently Asked Questions
What is a clinical trial?
A clinical trial is a medical research study that involves volunteers to help the medical field better understand and develop new ways to prevent, diagnose, and potentially treat diseases. This is the primary way that researchers find out if a new treatment like a new drug or medical device is safe and effective.
What types of clinical trials are there?
There are many different types of clinical trials.
In a typical clinical trial, one group of volunteers receives the drug being studied and another group of volunteers receives a placebo (aka a “sugar pill” which looks or acts like the study treatment, but has no therapeutic action) to compare the two groups.
In other trials, every volunteer may receive the drug/treatment being studied, with no placebo involved.
Some studies involve investigational drugs, while other studies involve already FDA approved treatments.
Some clinical trials take place in an office setting, while others require volunteers to sleep overnight for monitoring.
Every protocol is different and Pillar Clinical Research is happy to explain and guide you through any potential studies you are interested in.
Why do some clinical trials involve a placebo?
Comparing a study drug or treatment to a placebo often times is the surest and most effective way to demonstrate the effectiveness of potential new treatments.
Have you heard of the placebo effect? It’s become a known fact that even volunteers who receive a placebo in a research study can get better! Thus, clinical trials try to collect information to determine if the study treatment is actually more effective than the power of placebo itself.
Interested volunteers are informed before they enter a trial whether placebos are going to be used in the study and the risks and benefits of the study medication(s).
Why should I participate in a clinical trial?
Pillar Clinical Research sees it as a privilege to collaborate and work with research study volunteers. In our work together we hope that your participation will help us better understand how the study drug or device works in different people.
Some reasons to consider participating in a clinical trial:
- Access to new drugs or devices that may not be available on the market.
- Access to study medication or devices at no financial cost.
- Satisfaction in potentially helping advance medical research.
- Collaboration with your outpatient treatment team (with your consent).
- Potential compensation for participating in a clinical trial.
Am I eligible for a clinical trial?
Each clinical trial has its own specific set of criteria regarding who is or isn’t eligible to participate. For example. some of the criteria may be based off age, weight, what medications you are currently taking, how long you’ve had your illness, etc. Thus, not everyone who applies for a clinical trial will be eligible.
Once you contact Pillar Clinical Research. You will be contacted to set up a brief phone call screening call to obtain some basic information. From there, we will set up a no-cost “Pre-Screening” interview. Transportation to this no-cost office interview can be provided. This in person interview will help us determine whether or not you potentially qualify for a study. If you are a potential candidate we will set up an official “Screening” visit.
What is the Informed Consent document?
If you are a potentially eligible to enroll in a clinical trial, a “Screening” appointment will be scheduled. Once you arrive to the research site, you will be provided with an “Informed Consent” document that provides a description of the research study, the potential risks & benefits, your rights as a study participant, any agreed upon compensation related to study participation and emergency contact information. You will be given ample time to review this on your own in addition to having this reviewed with you by a designated research staff member. We will answer your questions and address any concerns, so you can make an informed decision to consent or not, or whether you’d like to think it over more before deciding. No research study related procedures will be performed until an informed consent is signed. You will be provided with a copy of the signed informed consent for your records.
What happens during a clinical research trial?
Once you complete the informed consent document, the screening visit can begin. The purpose of a screening visit is to determine whether or not you meet all of the eligibility criteria to move forward in the research study. Every study differs to some degree in terms of what takes place at screening, but in general volunteers can expect:
- Being interviewed to obtain your medical history
- Undergoing a physical exam & ECG (electrocardiogram)
- Getting your blood drawn & providing a urine sample for lab testing
- Filling out and/or getting interviewed for various health questionnaires and surveys.
In most cases, it may take a few days to a week for the lab results to return, for your clinical history & surveys to be reviewed, and for the final determination about your eligibility to be made.
If you meet all of the criteria for entry into the study, you will return to the research site for a series of study related visits. Depending on the study, you may be receiving the study drug or placebo during this time frame. Some studies are “double blinded” meaning that it is unknown to you and the treatment team which group you are assigned to. While other studies are “open label” meaning that both you and the treatment will know exactly which group you are in. The overseeing study physician can find out exactly which group you are in, if needed, in the case of a medical emergency.
Study visits typically involve: periodic physical exams, completion of surveys & clinician guided surveys, ongoing lab work for medical safety monitoring.
The total number, frequency and length of visits depends on the study.
End of Study Visit
Once you have either completed the scheduled study visits, elected to withdraw from the study, or needed to be withdrawn, an End of Study Visit is conducted. In general, the procedures and assessments at an End of Study visit are similar to what was conducting at your screening visit.
The research study staff will also discuss with you & coordinate with any of your outpatient providers (with your consent) to help determine your post-study treatment plans for followup. Some studies may require a “safety follow up visits” for further safety monitoring.
Safety Follow Up Visit
The purpose of these briefer visits is to monitor for any possible lingering study related issues and to ensure that they are either clinically stable or resolved before your participation is completed.
What are the risks?
Just as everyday activities and standard medical care carry potential risks, there are also potential risks involved in clinical research trials.
- There is no guarantee you will directly benefit from participating in a study
- Study drugs/devices may potentially cause adverse effects ranging from mild, to serious, to life threatening.
- Not all of a study drug/device’s adverse effects may be known at the time you are enrolling for clinical trial.
The specific risks associated with any clinical research trial are described in detail in the informed consent document, which you are asked to review and sign before taking part in a study. In addition, the potential risks and of benefit of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. It is important you understand and consider these risks before consenting to participate in a clinical trial.
Does it cost me anything to participate?
In most clinical trials, all study related visits, lab tests, medical assessments, and procedures are at no financial cost to the volunteer. In addition, you may potentially be compensated for your study participation depending on the research study. The specifics of such compensation will be described in the informed consent document.
What if I have no means of transportation?
Transportation to and from your home for both pre-screening visits and visits during a clinical research trial can be provided by Pillar Clinical Research. Don’t let transportation concerns stop you from reaching out to us.
About Our Studies
Pillar Clinical Research participates in clinical trials that involve novel investigational compounds as well as FDA approved products. Trials range from seeking volunteers who have not received any treatment for their current episode of depression to those who are currently getting treated but not responding well to their regimen. Follow our blog or social media for the most up to date info on open enrolling studies.
Pillar Clinical Research has expertise in conducting research studies for schizophrenia, “negative” symptom schizophrenia trials, cognitive impairment associated with schizophrenia trials, trials involving long acting intramuscular and subcutaneous injections in both inpatient and outpatient settings. Follow our blog or social media for the most up to date info on open enrolling studies.
Bipolar Disorder Research
Bipolar Disorder clinical trials typically involve outpatient bipolar depression studies as well as inpatient acute manic/mixed episode studies. Follow our blog or social media for the most up to date info on open enrolling studies.
Substance Use Disorders Research
Clinical trials for substance use can range from studies involving alcohol use disorders, smoking cessation to opioid/opiate use disorder in both inpatient/outpatient settings. Follow our blog or social media for the most up to date info on open enrolling studies.
Healthy Volunteer Studies
There are certain studies where healthy volunteers are needed. These types of studies are examining and learning about what a study drug and its chemical properties once someone takes them. How long does it take to absorb? Clear from the body? What adverse issues are noted? Follow our blog or social media for the most up to date info on open enrolling studies.