Clinical trials – Considerations for Vulnerable Populations
Clinical trials need to implementation in children and pregnant women; however, there is much to learn concerning the safe and efficient treatment of pregnant women having problems with their health, as well as how to stop the outcomes regarding poor pregnancy (Society for Clinical Trials, 2004). Clinical research should offer this kind of useful knowledge but still, there is unhealthful disinclination in involving pregnant women in the procedures of clinical trials. There is a tremendous need for regulatory clearness, for instance, the smallest risk that the trial can expose to the fetus. The legal responsibility worries still confront the efforts of clinical research; nevertheless, examples of clinical research demonstrate efforts ensuring that women on pregnancy gain from the clinical research such that at the end, knowledge concerning helping the pregnant women and the fetus to be healthy is attainable.
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Challenges of Conducting Clinical Trials in Emergency Medicine
Now researchers in the area of expertise face challenges arising from their lack of experience and knowledge concerning issues of research. Such issues may include the formulation of an excellent research question and a clear research protocol. As well, they may have the inability to judge between ad and good advice (Pawlik & Sosa, 2013). On the other hand, academic emergency medicine has faced limitations regarding the availability of centers, and the finding has been hard to obtain due to the non-supportive nature of the academic environment. A lot of pressures, emotions, and severe burdens have often interrupted the research alongside the ethical considerations of informed consent. Again, rotation of staff has made it very hard for the project to sail through in a single setting. Precisely, the challenges that need overcoming involve deviation, distraction, dejection, despondency, lack of concern, and dishonesty (Duley, 2002).
Concerns for Study Subject Diversity in Clinical Trials
To expand the enrolment of ethnic and cultural minorities in these experiments, changing the attitude of the minorities is not the answer. Instead, it is imperative to increase access to health research. Designing clinical trials should happen in such a way that it focuses on specific or target populations. The outcome of the laboratory needs to the application in finding solutions to real-world problems (Schwartz, Flamant & Lellouch, 1980).
Risks and Benefits in Clinical Trials
Advancements in the health care sector are about medical treatments rely on clinical trials. Clinical trials, therefore, aid in the discoveries of new or better drugs and therapy treatments for many diseases thus minimizing loss of lives as the results of these diseases. Clinical trials also enable the administration of evidence-based medical treatment thus increasing trust in the medical field. Moreover, clinical trials provide further knowledge concerning the subject of research that may result in better-improved outcomes and assists future studies since most of the clinical research is inspired by earlier research, failed or successful as suggested by DeRenzo & Moss (2006). For instance, the drug Lochol is expected to act as anesthesia during surgery and aid in treating instances of fear and anxieties, especially before surgery.
However, clinical research is full of uncertainties that may result to harm in case the research does not turn out as expected. For instance, clinical trials may jeopardize the health and lives of subjects in case of unexpected negative reaction attributed to the drug of therapy treatment under study. There is the possibility of individuals developing persistent side effects thus harming the participants. The drug or therapy under study may also be less beneficial compared to an already established treatment as claimed by Barke (2009). In the case of Local drugs, the drug could easily be abused by subjects leading to addiction thus dreadful. It could also be very lethal to children and expectant mothers.
I would continue with the drug development process by following up on the 2-week study because its benefits outweigh dangers considering the risks could be avoided. For instance, abuse of the drug could be minimized by creating awareness of the dangers of abuse and urging the participants to shun misuse. The drug being unfavorable to children cannot be a hindrance either considering most drugs are thus excluding children, and expectant mothers from the study would eliminate the endangered group thus safe to conduct as implied by DeRenzo & Moss (2006).
Increasing the Level of Participation in Clinical Trials
Poor participation by the public in clinical trials is among the factors hampering clinical research. Therefore, establishing effective ways to draw participants would prevent delays and consequently wastage of finite resources that have been the trend. Some of the strategies researchers have come up with to solve the problem of insufficient participation by the public in their research include novel recruitment strategy, recruitment difference strategy, and offering monetary incentives as stated by Bower et al (2009).
The effectiveness of recruitment strategies employed by researchers varies depending on the type of study and the nature of the targeted audience. This is because the public’s responsiveness to these strategies differs significantly hence difficult to determine the best strategy. Research conducted indicates that a strategy such as offering monetary incentives to participants is limited to a certain group of individuals thus not entirely effective. Recruiter difference and novel trial design strategies tend to focus on establishing rapport between participants and investigators the participants’ consent of the trial treatment respectively but fail to convince participants of their noble course. Therefore, they do increase participation but not as much as required as implied by Baquet et al (2006).
Focusing on strategies like interactive internet strategy that involves creating awareness on the disease under study would be advantageous. Major causes of reluctance in participation are a result of ignorance, cultural, and religious beliefs that contributes to the public negative misconception concerning participating in clinical research. Therefore, informing the public on the negative health impact of the diseases stressing the significance of finding the solution with their aid would improve the level of participation. The strategy helps clear any misunderstanding concerning the study and enhance trust. This can be done through seminars as advised by Paine, Stocks & Maclennan (2008). However, the process may be time-consuming but in the long run fruitful.
References
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