Frequently Asked Questions about Clinical Trials at BIOS

Clinical trials are carefully designed research studies that evaluate new medical approaches, including:

• Medications

• Devices

• Treatment strategies

• Prevention methods

These trials help determine the safety and effectiveness of new interventions, potentially leading to breakthrough treatments for various conditions.

Clinical trials serve one important purpose: to protect patients by making sure that only medical interventions that are both effective and safe get approved for use.

First, clinical trials are how we make sure that new treatments, procedures, devices, and other medical interventions are actually effective. If something isn’t effective, it shouldn’t be used as a solution to a health issue. So clinical trials enable us to prove if something does what it claims to before being made available to the public.

Second, clinical trials test whether something is safe for human use. By adhering to strict safety standards, clinical trials help us determine if the benefits outweigh the costs.

Our clinical research site offers participation in clinical trials of new HIV antivirals, many of which involve simplification and improved safety of regimens. The aim of this clinical research is to make HIV treatment easier to take, as well as reduce the long-term toxicity associated with older drug treatment combinations.

Participating in a clinical trial offers several benefits:

1. Access to novel treatments not yet widely available.

2. The ability to contribute to the advancement of medical knowledge.

3. You will receive expert medical care and close monitoring throughout your participation.

4. You can play a more active role in your own healthcare.

5. You help future patients by contributing to medical research!

Your safety is our top priority. All our clinical trials:

• Follow strict protocols approved by regulatory bodies.

• Are closely monitored by experienced medical professionals.

• Adhere to rigorous ethical standards.

Participation is always voluntary, and you can withdraw at any time.

Nope! Insurance is not required, and when you participate in a study, all visits and care related to that study are free.

Nope. In fact, many clinical trials have sites all over the world, so citizenship in a certain country is not required.

Clinical trials vary, but many pay participants for their time and travel related to participation if they qualify for the study. The schedule and method of payment also vary by study, so please don’t hesitate to ask how it will work for the study you’re interested in.

Joining a clinical trial is entirely voluntary, and participants can leave at any time without having to explain why.

Clinical trials are testing medical interventions that are not yet approved for public use. The trials are conducted in order to learn about the safety and effectiveness of an intervention, so there’s always some risk involved.

However, these trials are conducted under strict standards and with the watchful eye of our medical experts for the purpose of reducing risk and ensuring that you are safe. In addition, each trial is approved by an Independent Review Board (IRB) and monitored by an independent monitor on a regular basis to protect participant safety and rights.

Clinical trials test things like new medications, medical devices (like pacemakers), procedures, changes to behavior (like an exercise regimen), and diagnostic tests (like at-home COVID tests).

At BIOS, our focus is clinical trials that test new treatments and prevention for HIV, as well as for other infectious diseases.

Informed consent refers to the process used to ensure that all participants in a study know exactly what they’re participating in, the risks involved, that they can stop participating at any time, and what is required of them to participate in a study.

By law, every clinical trial must give an approved Informed Consent Form (ICF) to each potential participant. The trial site staff will go over the ICF with each participant to ensure they understand, and then participants can take it home to review with loved ones and/or healthcare providers.

When potential participants are ready to make a decision, they can either decline to sign the ICF and therefore not participate, or sign the form and join the trial. There is no obligation to participate once you’ve expressed interest; you can decline for any reason without having to explain.