Clinical trials are research studies designed to determine if a new medical intervention for a medical ailment is safe and effective. Research studies generally consist of monitoring a participant’s health and response to a particular new medication in a medically supervised environment to ensure safe and responsible testing of the new medical intervention, be it a drug, device or other treatment.

Each study has its own rules about who can — or cannot — participate. This is called “eligibility”. Eligibiity is determined and recorded ahead of the study, as ‘inclusion/exclusion criteria’, by the Researchers, depending on the treatment being tested and to ensure an objective as well as optimum study of the new treatment. Your eligibility may be based on your age, gender, overall health, type and stage of medical condition, treatment history and other conditions. If you’re interested in participating in a clinical trial/study, it is best to call our team and they can help verify your eligibility to participate.

It involves providing a potential participant with all the relevant information related to the study to allow you (the participant) to make a fully informed decision about participation in the clinical trial/study.

Benefits: You may gain access to new cutting edge drugs and other treatments, sometimes years before they are widely available, thus, potentially providing you immediate relief and better treatment for your condition. You are also playing an active role in your own healthcare and contributing to medical research as well as the advancement of science for all. Lastly, study participants are typically paid for their time and effort.
Risks: Some treatments that are being tested may have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors do not always know what the side effects will be – though most negative effects to be potentially expected are known before a Phase –III Clinical trial, you may react to the medication differently due to your unique genetic make-up, which could be positive or negative. Many side effects last a short time and go away when the treatment is stopped. Others can be long-lasting or permanent. The risks depend on the treatment being studied, and all known risks should be fully explained to you by the clinical research staff in advance.

If you are currently taking any medications, you will need to provide the names to our medical team so they can determine if there is any potential risk of a negative interaction. They will let you know if it safe for you to continue with your medication.

The length of each trial depends on sponsor specific parameters for testing a particular treatment – it could be as short as a few weeks to as long as a few years- it just depends on the study. Our Staff can help you understand this better depending on the study you’re interested in and are eligible for.

Every clinical trial must be approved and monitored by the FDA as well as an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

In general, participants can enroll in only one therapeutic clinical trial at a time.

Yes. Participation in a clinical trial is completely voluntary. You may choose to withdraw from the trial at any time. However, your premature withdrawal before the end of the trial will impact the clinical trial and therefore your participation as committed to the clinical trial is deeply appreciated.

No insurance is needed or required. Clinical Trials do not replace a Participant’s primary care physician and are designed to simply study a participant’s response to a cutting-edge/new medical treatment.

As a clinical trial participant, you are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect you by making sure you have been given all the necessary information about a trial. While a clinical trial may provide you ( the participant) with access to a new medical treatment for your condition, it will not replace your primary care physician.

Our clinical trials are confidential to all potential outside sources and your information is protected.

Clinical trials typically pay per visit, with compensation dependent upon the length of time required as well as the procedures performed. Compensation varies from study to study and is made known to each participant before they enroll as part of the informed consent process.

A Participant who is in a control group receiving the treatment ( therefore not in the control group receiving the placebo) may not see any negative effects or may see some negative or adverse effects, that could be minor or serious. The effects would depend upon the specific treatment being tested and would be supervised by trained medical professionals in order to evaluate the treatment for safety, efficacy and immediate as well as long term effects – therapeutic as well as negative effects if any. Typical negative effects to be expected are known before a Phase-III clinical trial. The range of negative effects in general include headache, nausea, weight loss, skin irritation, or other physical problems but would have to be seen specific to the treatment being studied/tested.

After the clinical trial is over, the data from the study is submitted to the FDA for the approval process to form basis for whether the treatment is approved to be made widely available. Your primary care is continued with your primary care physician. You are also able to track the progress of the treatment’s FDA approval.

Amongst the different benefits to the participant or medical science or society at large, at the heart of it, a patient volunteer/Participant has a known health problem and is an active participant in their healthcare. He/She participates in a study to better understand, diagnose, treat or cure that disease or condition, thus actively seeking to be part of the solution and in doing so, not only potentially receiving early access to innovative treatment at no financial cost but also being compensated for their time for each visit.

A placebo is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient that is completely safe and has zero side effects. An active agent is the ingredient in a pharmaceutical drug or pesticide that is biologically active.

In a single-blind study, only the participants are blinded, not knowing whether they’re in the control group being administered the drug or the placebo. In a double-blind study and more common for scientific accuracy, both participants and Clinical Staff are blinded to ensure each participant receives the same level of attention and all observations are objective.

A clinical study cannot guarantee you will receive the drug/new treatment. You may be in the control group receiving the placebo but your participation and the data from the placebo participants is invaluable in providing the required contrast to the drug response without which the FDA is unable to approve the drug and make it available to you sooner as part of its release to society at large. Being a participant thus ensures you’re part of the solution that will provide real relief to the millions suffering like you while potentially providing you early access to the drug at trial and being compensated for your time.