Many of medical advancement nowadays are for better health care and accurate treatment. One of these medical developments is the clinical research. Based on the reported study, there are over “14,000 clinical trials” are on the move to the country every year, so most likely nurses will encounter different kinds of a patient that involves in, or considering the clinical trial as an option for cure. But there are also patients that refuse to undergo for clinical trials and nurses consider this a big challenge to their profession (The CI & SOCP, 2013). Therefore, what information we should use to let them understand this outbreak advancement; Apart from that, how are we going to assess the reliability of clinical research if the process becomes failure?
Actually, the reliability of clinical research can be measured through clinical trials. A method evaluates the effectiveness, safety, and treatment intervention. It follows a protocol or guidelines to ensure the treatment is carefully undertaken. More especially, the “randomization controlled trial” on the issues of allocation concealment, size sample, blinding, and randomization, these issues can mainly affect the internal validity of trials. With regard to external validity of trials, one must also consider the following issues. As such, the study population, length of follow-up, types of interventions used, and the trial setting (Akobeng, 2008).
This allocation concealment is responsible to protect the randomization process. It will also prevent discrepancies and other selection biased of the controlled trial. Tendencies are the participants of the trial will not be tempted to decipher the task. Thus, it results to reliable outcomes or effective conclusion (Schulz KF, 2002).
Secondly, the size sample can also affect the reliability of a controlled trial. It is very important to have sufficient sample size in the process because it can affect the entire assignment. Mostly, the participants will rely on integration of meta-analysis, stopping rules, and information size calculations to trial sequential analysis (TSA) before the actual process, which is likely similar to group sequential analysis in single randomize controlled trial. This is very useful in determining the numbers of patient need to undertake the randomized trial. Moreover, it prevents also the risk of false or overly positive findings from random error. However, it requires a solid source of literature references to back-up the result and eventually proved the hypothesis. If certain cases the outcome is not successful, then there’s a strong possibility the trial will be terminated immediately (Thorlund & et al, 2010).
Investigators and clinical researchers are sometimes overlooked the blinding component in the process, which can also lead to false or bias result. In some articles, they use the term such as single, double, and triple blind to, plainly illustrate the resulting data. In the trial, the blinding strategy should clearly describe of whom among the key trial patients are need to be blinded. Although, it’s not necessary to blind all the key trial person, however, depends on the subject and precision required in the study (Kolahi & et al, 2009).
Moreover, the randomization component is usually associated to trial blinding. The methods used are simple or blocked style. Initially, the subject will be tagged with a unique identification code or terms. During the simple randomization, there’s a tendency the result will be clustered and creates random error. Therefore, the blocked randomization is mostly preferred when determining concrete data (Kolahi & et al, 2009).
The significance of protecting the internal validity trial is to have unbiased information with regards to efficiency and adverse effect towards patient. It will also determine the accurate rate of efficacy to certain subject, by way of comparing the treatment result to the standard one.
External validity is also considered in taking the process to evaluate the effectiveness in different population. Thus, it gives knowledge on how the treatment will be done eventually.
On top of all, the reliability of clinical research will depend on how the clinical trials are undertaken. The methods and strategies’ used are mainly top priority when obtaining the data because it affects the actual result. At times, it leads to false adversity that can be lethal sometimes or ineffective treatment. But overall, results are tremendous in some people because they are given hope to extend their lives in some other way.
How about the patient, who refuses to undergo clinical trial, what information should we used to let them understand this outbreak advancement. Actually, the person involve in the assignment are voluntarily agreed. If certain cases someone will refuse to undertake the trial, they will not be forced. However, the clinician will explain the effect of not taking the risks and the advantages of grabbing the opportunity to heal. Although, it’s not necessary to explain the methods of the assignment, but the most noteworthy thing is to give them hope to be treated. In some way, they will have something to look after for.
References
Akobeng, A. K. (2008). Assessing the Validity of Clinical Trials. Journal of Pediatric Gastroenterology & Nutrition Volume 47 - Issue 3, 277-282.
Kolahi, J., Bang, H., & Park, J. (2009). Towards a proposal for assessment of blinding success in clinical trials. Community Dent Oral Epidemiology , 477–484.
Schulz KF, G. D. (2002). Defending against Deciphering. Allocation concealment in randomised trials, 614-618.
The Center for Information & Study on Clinical Research Participation. (2013, May 02). Information about Participation and Clinical Trials by Ethnicity, Age and Gender: Volunteer Demographics. Retrieved from www.ciscrp.org/professional/facts_pat.html#7
Thorlund, K., Anema, A., & Mills, E. (2010). Interpreting meta-analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals . Clinical Epidemiology, 57-66.
