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Cook Children's investigational drug services (IDS) pharmacy coordinates all pharmacy processes and coordinates the use of drugs in research clinical trials. There are several steps to make sure that protocols are met and regulations are followed.
All protocols with a pharmacotherapy component are reviewed by the IDS pharmacist to see if there are any IDS- related issues, as well as feasibility and budget requirements. This review includes looking at implementation requirements, how the drug will be prepared and given to research participants and the potential costs associated with the study.
Once Cook Children's approves the protocol, the IDS pharmacist prepares for the research trial in the pharmacy.
The process includes:
The IDS pharmacist will provide patient counseling on all initial prescriptions for investigational agents, when possible.
The IDS pharmacy and research staff is responsible for ordering, receiving, expiration tracking and documentation of all investigational drug shipments.
The IDS is responsible for the integrity of drug management for all clinical trials within the Cook Children's system. The following measures have been developed to ensure proper conduct is followed.
Compliance with protocol and regulatory agencies is a strict requirement. The IDS pharmacist makes sure Cook Children's follows state and federal regulations including CFR title 21, Health Insurance Portability and Accountability Act (HIPPA), Joint Commission on Accreditation of Health Care Organizations (JCAHCO) and the state board of pharmacy.
The IDS pharmacy is made up of pharmacy staff that is responsible for preparing and dispensing the medicine your child will be taking during the clinical research study.
An investigational drug pharmacist as well as other medical center staff pharmacists and certified pharmacy technicians.
IDS has taken many steps to prepare and dispense your child's study medicine. These steps can take more than an hour, depending on the study. The steps are explained in further detail below.The IDS pharmacist receives a prescription for your child's study medicine and reviews the order to make sure it's correct. The pharmacist will confirm the dose based on your child's height and weight, and according to the protocol. They will then review your child's medicine history to make sure there won't be interactions with other medications. Finally, they will review lab test results, if needed.
Once the order is verified, the study medication is entered into the computer system which creates a prescription label for your child's medicine. If your child is taking a study medicine by mouth, it will be prepared and labeled in the main Cook Children's pharmacy. If your child is receiving a study medication through an IV, it will be prepared and labeled in a special mixing area using sterile techniques.
The pharmacist must then record every vial, tablet, capsule or liquid medication into the investigational drug inventory log. This log is required for the pharmaceutical company sponsoring the study and the Food and Drug Administration (FDA) upon request. The IDS pharmacist spends several hours each week documenting inventory and dosages dispensed to patients on drug accountability logs.
We ask you to return all medicine containers, even empty ones, to follow the requirements of the pharmaceutical company sponsor, as well as state and federal regulations regarding the accountability of study medications. These returned containers are recorded in the drug accountability log which is given to the regulatory agencies.
A placebo is a medicine or intervention that is not expected to make a certain disease or condition better. Placebos will usually look like the real treatment medicine, but it does not contain the actual drug. A sugar pill is a good example of a placebo.
A placebo helps researchers separate placebo effects from the actual effects of the drug or treatment being studied.
Our mind is a powerful thing and sometimes our own expectations and beliefs that a medication or treatment will make us feel better, can actually affect how our body responds to the treatment. Basically, if we believe the treatment is going to make us feel better, then we will actually start to feel better. This is called the placebo effect.
When studying a new medicine or intervention, it is important for researchers to compare these placebo effects to the actual effects seen from the drug. This allows researchers to decide whether the actual drug being studied is effective.
During the study, if an investigational medicine seems to work well, the researcher may stop using the placebo. This decision depends on many factors including the interventions being studied, the medicine and the illness. These decisions will vary from one study to another. You can ask the doctor this question when you are considering participation in a study.
Randomization divides the research participants into groups. One group (the experimental group) will receive the treatment, medicine or test and the other group (the control group) will be the comparison group and does NOT receive the treatment or test being studied. The children in the control group may receive no treatment at all, the standard treatment for the disease or a placebo. This will depend on the study.
Randomization is often the best way for researchers to have study groups that have similar characteristics, including age and ethnicity. These similar characteristics allow researchers to compare the results at the end of a study.
The use of new medicine takes place in controlled clinical trials designed to find out how safe and effective the medicine is. Sometimes, patients do not qualify for these trials because of other health problems, age or for other reasons. The Food and Drug Administration has created special exceptions for these patients that may benefit from the medicine but do not qualify for the trials. These exceptions allow the makers of investigational medicines to provide "expanded access" use of the drug. This means the drug might be used outside of a clinical trial. These "expanded access protocols" are only allowed if researchers are actively studying the new medicine or treatment in well-controlled studies, or all studies have been finished. There must also be evidence that the medicine may be an effective treatment in these patients and can't expose patients to unreasonable risks.
A treatment IND (Investigational New Drug) or treatment protocol is a relatively unrestricted study. It provides access to a new medicine for people with a life-threatening or serious disease for which there is no other good treatment. Another reason for a treatment IND is to get additional information about the medicine, especially its safety.
Medical research may seem a lot like your child's current medical therapy. For example, both usually occur in a hospital or clinic setting, health care workers (doctors, nurses, etc) are usually involved in providing care and both present some potential risk. However, there are differences in how medical research and medical therapy are conducted. It is important to recognize and understand these differences when making a decision about whether or not your child should participate in a study.
The focus of medical therapy is to give medical care and manage your child's illness or injury and improve his or her health. The direct benefit to your child is the main goal. In medical research, the main focus is to gain information which can be used to improve treatment for all children. This means that the direct benefit for your child is not the main goal. However, it is not uncommon for some research to offer health benefits to children that are participating.
It is also important to realize that if the research involves any significant risk, the balance of the risk to your child versus the benefit to your child must be at least as good as it is for the current standard therapy they would receive.
When a child receives medical therapy, treatment may be adjusted to meet the needs of the individual child. For instance, one drug may be substituted for another or the timing and how the drug is given may be changed to meet the needs of that child. When conducting a medical research study, it is important for the study to meet its scientific goals. This can only be done when the treatments of the children in the study follow the exact study design or protocol. If parents want to change treatments that are not allowed according to the protocol, you can withdraw your child from the study at any time. However, it is important to keep in mind that there may be potential benefits for your child when following the protocol.
In medical therapy, parents agree to treatments to make their own child's health better. When children participate in medical research, parents give their permission to participate in the study. Parents may do this for several reasons, some of which include the hope that it will benefit their child, but that it may also help other children suffering with the same medical issue.
In medical therapy AND medical research, health care providers are involved in the care and treatment of the child. In medical therapy, the primary responsibility of health care providers is to treat your child's illness and improve your child's health. When conducting medical research, health care providers are also required to follow the study protocol.
When considering participation in medical research, it is also important to think about parental responsibilities which might include: