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 on 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, we will conduct a brief phone screen to see if a study may be a good fit for you. From there, we will set up a no-cost “Pre-Screening” interview. Transportation to this 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.

Once you arrive at the research site for your “Screening” appointment, you will be provided with an “Informed Consent” document. This document provides a description of the research study, the potential risks and 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.

Screening Visit
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 and ECG (electrocardiogram) Getting your blood drawn and 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 and surveys to be reviewed, and for the final determination about your eligibility to be made.

Study Visits
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 and 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 have been withdrawn for safety reasons, an End-of-Study Visit is conducted. In general, the procedures and assessments at an End-of-Study Visit are similar to what was conducted at your screening visit.

The research study staff will also discuss with you and 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 visit” for further monitoring.

Safety Follow-Up Visit
The purpose of these more brief 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.

Just as everyday activities and standard medical care carry potential risks, there are also potential risks involved in clinical research trials.
For example:
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 benefits 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.