About Clinical Trials
What are Clinical Trials?
The process of developing a new drug is a lengthy one. Because of the stringent regulations established by the Food and Drug Administration (FDA), the process can take as long as 9 years, from the time the molecule is first discovered to the time it reaches your doctor’s office or pharmacy shelves. It begins with testing the new drug on animals to help predict how it will affect humans. This is called the pre-clinical phase and usually takes around 18 months to complete. The next step in the drug development process is clinical research and development – also known as clinical trials. There are four main phases of clinical trials, which will be explained in more detail below. Although lengthy, the drug development process is designed to ensure the safety and welfare of both clinical trial participants and after market consumers, while also making sure the new drug is effective.
Human Drug Testing: The Phases of Clinical Trials
After animal testing has concluded, the drug company submits a full report to the Department of Health and Human Services. This report includes details of the drug’s composition, preparation, manufacturing, and conditions of use, along with the animal test results. This report must provide evidence of the drug’s therapeutic activity in animals and its promise and safety for human testing. Once approved, the drug can move to the Investigational New Drug (IND) Stage, and human testing can begin.
Phase 1 studies usually start small, since the effects of the new drug on humans are difficult to predict from animal tests. A small number of volunteers are chosen – anywhere from 20 to 100 people. These volunteers must be young, healthy, mentally stable, consenting adults that can accurately describe their experiences. This phase usually lasts several months and its main purpose is to determine the safety of the new drug and any side effects.
After establishing the safety of the new drug in Phase 1 studies, researchers move on to Phase 2 studies to establish the drug’s effectiveness on a certain disease or disorder. More volunteers are needed for this phase – usually several hundred people. Studies in this phase are mostly randomized and double blind with either a placebo or a well-established drug acting as a control. “Randomzied” means that patients are randomly assigned to a treatment group (for example, either the study drug group or the placebo group). “Double blind” means that neither the patient nor the doctor knows what treatment the patient is getting. There are two main goals of Phase 2 studies: First, determining if the drug is effective when given for a certain time at a certain dose. And second, finding out of the drug is better than the drugs already on the market.
Phase 3 studies open up the testing population to thousands of patients. The main purpose of Phase 3 studies is to gather safety data on a large number of people. This helps better understand the drug’s effectiveness, possible side effects, and dose regimen. This is usually the longest phase of drug development, lasting several years. Many studies are open label (both doctor and patient know that the patient is on study drug) or single blind, which means that the treatment group is not concealed from the doctor. Once Phase 3 studies have been successfully completed, the drug company can submit a New Drug Application (NDA) to the FDA for approval to market the drug.
Phase 4 studies are sometimes referred to as Post Marketing Surveillance Trials and occur after the FDA has already approved the drug for consumers. As the name suggests, the purpose of this phase is to continue monitoring the new drug for long-term safety and effectiveness. Cost analysis and drug comparisons are also investigated during this phase of research. In some cases, a new drug can be taken off the market or restricted based on findings in Phase 4 studies.
Who pays for clinical research?
Clinical trials can either be funded by the U.S. government (like the National Institutes of Health) or through privately owned companies, like pharmaceutical companies and biotech firms. Lake Charles Clinical Trials primarily conducts trials sponsored by pharmaceutical companies. The research sponsor hires clinicians from all over the country to help conduct their clinical trials. The clinicians usually receive payment directly from the study sponsor on a per-patient or per-procedure basis. Because of this payment model, volunteers can participate in clinical trials at no cost and health insurance is not needed. Additionally, medical care is provided for free to study patients.
Lake Charles Clinical Trials has worked with the following sponsors:
- Forest Research
- Johnson & Johnson
- Eli Lilly & Company
- Intra-Cellular Therapies
- Bristol Myers Squibb
- Memory Pharmaceuticals
- US WorldMeds (with NIH)
- Dainippon Sumitomo Pharma
- Elan Pharmaceuticals
- Hisamitsu Pharmaceutical
- Daiichi Sankyo Pharma
- Catalyst Pharmaceutical
- Columbia Northwest
- Harvard Clinical Research Institute
Why volunteer for a clinical trial?
There are both benefits and risks to participating in a clinical trial, and the decision to do so should be considered carefully with your primary physician and loved ones.
- Gain access to new treatments that are not yet on the market
- Help others by advancing medical knowledge
- Receive excellent medical care for the duration of your participation
- Receive diagnostic consultation at no cost
- Experimental drug may cause serious or life threatening side effects
- Treatment may not be effective
- Clinic visits may be lengthy and frequent
Participation in a clinical trial is always voluntary and you may withdraw from a study at any time, for any reason. Patients’ safety and welfare is always the primary concern in clinical research, and this is protected in two primary ways. First, an Institutional Review Board (IRB) must approve all studies. The IRB is an ethics review panel usually made up of scientists, physicians, religious leaders, and other people in the community. Its primary duty is to ensure that the study does not present any unnecessary risks to patients or violate patients’ rights. Secondly, all studies require careful review of an informed consent form prior to participation. The consent forms are approved by the study’s IRB and provides details of study procedures, possible side effects and any other risks involved, as well as doctor contact information.
If you are considering volunteering for a clinical trial, our friendly and experienced staff can answer any questions you have. There are also several online resources that can help you better understand clinical trials. Click here for a helpful list of questions to ask your doctor before participating in research.