CLINICAL TRIAL FAQ Back to Top

What is the process for drug development?

Drug development begins with preclinical or laboratory research which can involve years of testing on human cells and in animals.  If the information gathered looks promising, the pharmaceutical company sends the data to the FDA and requests permission for human subjects testing. This testing is comprised of Phases I-IV and takes 2 to 10 years to complete.  Clinvest conducts Phase II-IV studies.

Phase I studies are conducted in a small number of “normal, healthy” volunteers who stay at a research facility for one to several days.  The purpose of these first studies is to evaluate drug safety and how the drug is processed by the human body.  These studies also evaluate side effects that might occur as drug dose is increased.  Approximately 70% of investigational drugs pass this testing phase.

Phase II studies are conducted in people who suffer from the disorder for which a drug is being developed.  The drug’s efficacy, safety, and side effects are evaluated during this phase.  The investigational drug is compared to a placebo or a standard treatment.  Often, these studies are “blinded” so that neither the researchers nor the participants know who has been randomly assigned to receive the investigational drug.  The second testing phase involves up to several hundred participants and lasts from several months to two years.  Approximately 30% of investigational drugs reach Phase III testing.

Phase III studies are also “blinded” and involve several hundred to several thousand participants randomly selected to receive the study drug, placebo or a standard treatment.  These studies involve many research sites, and may be conducted worldwide and provide more thorough information regarding the drug’s efficacy, safety and side effects. During this phase, information compiled from all the studies is presented to the FDA in hopes the drug will receive approval.  The number of drugs that successfully complete this testing phase ranges from 70‒90%.

Phase I-III studies are well-controlled and closely monitored.

Phase IV studies are commonly referred to as Post Marketing Trials because they are conducted after a drug has received FDA approval. Drugs are further scrutinized for long-term effectiveness and safety. Additional objectives may include evaluating the drug for use in other circumstances, varying doses of the drug, and its cost-effectiveness or impact on participants’ quality of life.

What are clinical trials?

Clinical trials are medical research studies in which patients participate as volunteers. Clinical research studies are an integral part of the development of new treatments and medications for diseases and conditions. Some studies provide researchers with information that may be an important first step toward developing a treatment. For example, research may show how a disease progresses or affects other systems in the body.

How do I know if it's safe to participate?

Clinical trials are closely monitored by the Food and Drug Administration.
Additionally, medical research studies must be reviewed by Institutional Review Boards (IRBs) prior the start of enrollment and throughout the study. IRBs are independent boards comprised of scientific and lay people who are outside of the influence of study sponsors. The sole purpose of the IRB is to ensure that human subjects used in any research project are protected against undue risk, their rights are protected, and that they give informed consent to participate in the research.

What does participation involve? Back to Top

Each study has specific requirements. If you meet those requirements and are interested in enrolling, you will be scheduled for a screening visit. Before any study procedures are performed, you will be given an informed consent form that explains, in depth, the study being undertaken including all procedures that will be performed, number of visits required, and any known risks involved. We encourage you to take the consent form home to discuss with your physician, family, and friends prior to your agreement to participate in the study.

Your participation is entirely voluntary. You may withdraw at any time and can be assured that your medical care will not be affected.

How might I benefit from participating?

Research studies may involve promising new treatments that may directly benefit patients.
Study- related medical assessments, study drugs, and procedures, required by the study, are provided to you free of charge.
Your medical conditions will be closely monitored throughout the study.
You may discover other treatment options available for your disorder.
You may gain satisfaction from knowing you are contributing to a study that may benefit and advance medical science.
You may receive compensation for your time and travel while participating in the study.

Ready to learn more? Back to Top

We're here to help you make an educated decision about participating in a research study.

Call 417.883.7889 or 417.890.7888 today and talk to one of our research professionals. We will be happy to tell you more about studies currently being conducted and see if you qualify for one of them. You can also become part of our database by answering a few questions and granting us permission to retain your information so that we can contact you when we have a new study that may match your qualifications.

Visit our Enrolling Studies section for a summary of our current studies.

Join our e-mail list to receive updates on current studies. Click here.

Volunteer for your future!