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Introduction to medical research
A clinical trial, also known as a medical research study, involves consenting people to help test potential new medicines and devices. There are strict rules researchers must follow to protect the overall safety of all study participants. The end result of the clinical trial is to prove the safety and effectiveness of the new medication or device in treating a particular disease or condition.
The information gathered is presented to the FDA (Food and Drug Administration) for review. If all goes well, a new medicine or device is approved for use in the general population. Not all trials involve a new medicine or device. Some clinical trials are looking at already approved medicines or devices to be used in a way not previously approved. For example, an approved adult medication that wants approval for use in the teenage population must go through a trial to make sure it works as well for teens as adults. Studies must be conducted in a wide range of people. Many trials are world wide.
There are many phases of clinical trials
Phase 1 studies use a few healthy volunteers to test for the most effective way to administer or use the product and determine how much can safely be given to people.
Phase 2 studies have more volunteers. They must have the condition the medicine or device is designed to treat. This phase is to test how well the product works to treat that condition.
Phase 3 studies only occur if the medicine or device did well in treating the medical condition in the phase 2 trial. This phase has a large number of participants with the target disease. This phase is done to compare the new medicine or device with an already approved standard of care. The FDA is looking for new products to be better than the old in order for the product to be approved for market.
Phase 4 studies are conducted for medicines or devices that are already approved and more research is being done to check long-term safety. This phase can be used to help change the current indications, or an already approved medication to include other diseases or conditions. This phase of clinical trial can be observational. This means we watch and record the medical records of the participants and nothing else is required from the participant.
The only way a new device or medicine can become available to the general population is through clinical trials. Imagine life without aspirin or penicillin. We also require stronger pain medicines, better antibiotics, and more life saving medicines or devices. The only way to advance is through your participation in a clinical trial. Many people join clinical trials for the opportunity to receive the latest, most effective products that may help treat their current condition. Many join to help improve healthcare not just for themselves but for humanity and their family.
It is important to remember researchers cannot make any guarantees to the participants regarding the product they may get or the results they may experience. The whole purpose of the trial is to compare the new with the old or a placebo (looks like medicine but has no medicinal properties) to determine its safety profile, effectiveness, and the dose amount needed to be effective.
The only way medicine advances is through the participants joining clinical trials. Without the process of clinical trials, we would have fewer and less effective medicines and devices in which to better our lives. A willing volunteer is just as important as the scientists who discover, the doctors who treat, or the humans that suffer. Without the volunteer, none of them have hope.
There are many rules and regulations that are designed to protect the safety and rights of study participants.
The Food and Drug Administration (FDA) is a government agency in charge of insuring clinical studies are conducted by the strict rules mandated. The FDA rules over scientists, records, clinics, and research facilities. They respond to complaints received about clinical trials.
Institutional Review Boards (IRBs) are made up of community volunteers, doctors, scientists and other experts whose responsibility is to insure study participants are exposed to the least possible risks. They also make sure the participants are fairly selected and are informed of all study related procedures and are not coerced into agreeing to be in a study. This is accomplished with the implementation of a document called an informed consent. We will discuss this more in another section.
Data monitoring committees review information gathered during clinical trials to insure studies remain safe for the participants. They will stop any study proving to be harmful or of no benefit to participants. They also can end a study if one product shows to be better than the other. If this occurs the participants will then receive better treatment.
The implementation of the above agencies and the desire to do no harm to anyone makes research as safe as it can be. The industry has come a long way and many thousands of people volunteer in programs that may help them or their loved ones in the future.
The FDA requires a document called an Informed Consent to be given to every participant prior to any study related procedures being performed. The IRB reviews this document to insure it is in a language that is concise, complete and easy to understand. You are given ample time to read, review and ask any questions you have. The study staff and principal investigator (the doctor in charge of the trial) will be available to help answer your questions. You have the choice to sign and participate or decline to participate. You should not sign until you understand and are willing to comply with the rules of the trial.
The informed consent will consist of the following information:
- The purpose of studying the investigational medicine or device.
- How long you will be asked to participate in the trial.
- The possible risks and benefits of participating.
- Other available treatment options.
- The promise to keep your records private; remembering the FDA and clinical site will be using your records to gather information for the trial.
- What happens if you become sick as a result of the trial? Where can you get treatment and who pays for the treatment?
- Contact information to answer questions about the trial and your rights.
You will be greeted and taken to a room where you will be presented with an informed consent. You may read the consent then decide to participate or decline. If you decide to participate, you will sign and initial each page of the informed consent. Study procedures will then begin. We will check your medical records and ask you questions to see if you meet all the criteria to join the trial you are inquiring about. There may be a screening period to check compliance with trial procedures or to wait for the return of your laboratory values. Once you are in the trial, you will be placed in a treatment group established by a randomizing call to a designated call center. You may be on a new medicine or device, approved medicine or device or a placebo (looks like medicine but has no medicinal properties). The site will not know what you are on. This is done to prevent bias in research results. There are many types of visits. You may have a blood draw, EKG (heart tracing), height, weight, blood pressure, heart rate, x-ray, and many more procedures depending on the trial. Neither you nor your insurance will be charged for any study procedure done during the trial. You may be asked to keep a diary. You will be scheduled for your next visit. In clinical trials, it is important to keep your appointments. You will not wait in a waiting room for hours. In research, you are scheduled and you are seen in a timely manner. Your first visit may take a couple hours or more. Ask your coordinator before you come about how long you will be here. Some visits may be as little as 10 minutes or just a phone call. There are strict guidelines as to when you can be scheduled for your visits. There is some flexibility. You will be given a phone number you can call 24 hours a day in case of emergency, while you are in the trial. You will also receive your coordinator’s phone number for calls during regular business hours.
You will read how much is paid to you for your participation in the trial. This varies from trial to trial and is not meant to be the reason you join a study. You may receive $25.00 to $2,500.00; the amount is disclosed in your informed consent form. We mention this last because we believe participants join trials for many reasons and money is not the main one.
You have committed to the clinical trial. We have committed to you. The world may benefit. Have fun and enjoy meeting your new research friends; you may be surprised how helpful we can be. Many participants refer friends, family and co-workers and are well-pleased with the services we offer at no charge.
Thank you for considering research with…RESEARCH INTEGRITY