Clinical Drug Testing in Children Are the drugs that healthcare providers give to children safe? It is difficult to know this without performing various clinical tests involving children. On the other hand, testing some drugs on children may do harm to this young population. This is a very interesting topic, with many ethical dilemmas involved. As a healthcare provider and future parent, it is important to me that the drugs children are taking are providing a therapeutic effect, and not doing any damage to their bodies. To me, pediatric nursing is very interesting. Working with children and their families is something that I look forward to doing. I want to be able to pass my patient’s medications with confidence, knowing that the medications they are taking are known to help them through their illness. Parents also feel that it is important to know that drugs are safe for their children. By doing clinical drug testing in children, the healthcare community can determine the best medications to give, the safe dosage to administer, and also when to not give a medication. Currently, there are few pediatric drug trials in the United States. This has resulted in many potentially harmful or ineffective drug treatments. The healthcare community is forced to use the results obtained from adult drug trials to apply drug therapy to children. This is not truly reliable because children’s bodies metabolize substances different than adults. Children also have different diseases than adults (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). The benefits of clinical drug trials in children include providing access to treatments that might not otherwise be available to children. It has been found that children that participate in drug trials are monitored closer than those not in the trial, and also the participants are taken better care of (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). There are many risks that come with participating in drug testing. These risks include the children being in discomfort, pain, separation from parents and familiar surroundings, as well as effects on their growth. Participation in drug testing also can be an inconvenience for the parents or guardians due to having to take many trips to the hospital or clinical setting (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). The way the United States tests drugs in children has been changing. For example, the National Institute of Health has required children to be a part of any human research they conduct. The United States government has also given the pharmaceutical industry monetary motivation to include children in drug trials. Difficulty including children exists because the pharmaceutical companies are mainly driven by political and economical pressures (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). As a society, the United States places a bigger emphasis on protecting children than on increasing our knowledge concerning pharmacotherapeutics in children. Both parents and pediatricians first choice is to protect children (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). If a drug trial is thought to be remotely unsafe, participation won’t be considered. Some of the pediatric drug trials offer payment if a child chooses to participate. The problem with this is that the client’s decision making might be negatively influenced. Another negative influence is that some people view drug testing as inhumane. The majority of drugs prescribed for children have not been approved for use in children. By using these unapproved drugs, children are put at risk. There needs to be a balance between providing drugs that are proven safe and protecting against unexpected effects. Why aren’t there more pediatric drug trials? First, the cost of providing trials exceeds the market demand for the drugs. Second, it is difficult to find willing participants. Third, the ethical impact of studying children is questioned. Finally, there are a limited number of companies prepared to provide trials (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). Other factors contributing to small numbers of pediatric trials include the number of pediatricians that are hesitant to recommend the trial to clients. Parental consent is another barrier to finding participants. Some of the benefits parents may find from participating in drug trials include new treatments, improved care, increased health care information, exposure to other families in this position, new hope, and knowing that they are doing something to help their children. On the other hand, parents may view participation as being inhumane, anxiety and fear may be present, and parents may think the researchers aren’t concerned about their child’s health (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). What does the future hold for pediatric drug trials? If the public’s knowledge concerning the necessity and the benefits of drug trials is increased, participation may also increase. There are also a lot of negative feelings associated with drug testing procedures in children. Perhaps changing the way these trials are conducted will change the way the public thinks of the testing process, and the image of human guinea pigs will diminish (Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C., 2004). The debate about clinical testing in children greatly affects the nursing practice. As nurses, it is important to be confident that clients are given safe care; this includes administering safe medications. Nurses need to be able to assure their clients that the medications they are taking are helping them, rather than harming them. Nurses also need to have the knowledge to be able to discuss drug trial participation with their clients. Clients will frequently look to nurses for help in making the decision whether to participate in a drug trial or not. This requires the nurse to have the knowledge concerning both the positive and negative consequences of participation. Nurses need to remember to keep an unbiased attitude when discussing potential drug trial participation. Careful values clarification is important for a nurse to examine how one feels about drug testing. Because it has many ethical issues involved, thinking about how drug testing affects the nursing practice is important. Understanding one’s own individual feelings about drug testing will help the nurse talk with their clients about clinical drug testing in children.
References
Caldwell, P.H., Murphy, S.B., Butow, P.N., & Craig, J.C. (2004). Clinical trials in children. Lancet, 364, 803-811.