The Practice of an Assumption-Free Clinical Practice - Essay Example

Compare and contrast the randomized control trial and the phenomenological approach to research and their potential relevance to clinical practice Introduction It has always been a practice of clinical practice to look for designs and methods of study that assure greater reliability and applicability. The competitions between different available means of study designs have always been won with great success by randomized controlled trail. Being proud, in the circle of clinical practice, randomized controlled trial has rarely accepted any serious penetration of another competent study method within the practice of clinical practice. Like all other physicians and pharmacists, researchers and experts, technicians and thinkers, we too honor randomized controlled trials from the depth of our scientific mind. However, since the origin of respect for randmised-controlled trials was from the scientific mind, we hold the ground to even question, challenge, and compare its efficiency of providing a quality data with other seemingly better research methods. This does not mean that we disagree with the substantial standing of randomized controlled trials, but it exposes that we are always on the look of further improvement. In the present essay, we present an essential comparison between randomized controlled trials and phenomenological research in the practice of clinical practice. We begin with the essay by introducing good clinical practice, randomized controlled trials, and phenomenological research. Later we compare and contrast the randomized control trial and the phenomenological approach to research and their potential relevance to clinical practice . Good Clinical Practice Strict adherence to the set of rules and regulations provided by International Conference on Harmonization constitutes a good clinical practice. It is important to note that International Conference on Harmonization is an international body that regulates clinical trials involving human subjects. The important rules as proposed by the International Conference on Harmonization include: 1. Protection of human rights in clinical trials 2. Assurance of safety of the new drug 3. Assurance of efficacy of the new drug Good clinical practice guidelines include regulations on how clinical trials are required to be performed, the roles and responsibilities that are essential for following by the clinical research investigators, clinical research associates, and clinical trial sponsors. Randomized Controlled Trail A randomized controlled trial can be defined as a form of scientific procedure used in the study or testing of the efficacy of medicine or medical procedures. Thus, randomized controlled trials efficiently add to the existent scientific knowledge about therapy and therapeutic agents (Lei, 1991; Rohatiner, 2001). It is also essential to consider that a randomized controlled trial is the most reliable form of scientific evidence. This is because of its potential to eliminate a variety of biases that hold the disadvantage of providing comparatively lower quality of research results. The pharmaceutical industries hold a potential need to convince the physicians and the patients about the activity of a therapeutic agent. Thus, confirmation is a must and an essential step in the sale of the medicine. The sale of a medicine can thus be enhanced to still a greater level by projecting even better study responses about the drug. This certainly demands a greater contribution of research of higher quality. Thus, a randomized controlled trial finds its unique place in helping promote a therapeutic agent and thereby enhancing its sale. It is also essential to note here that non-randomized controlled trails are many a times difficult to interpret. This difficulty in interpretation can be considered to be of presence because of the difference in the control and intervention group. And also presents a sometimes-distinct difference in the prevalence of prognostic factors, such as age, sex, other illnesses. Thus, random allocation practiced in randomized controlled trails is an efficient way of making intervention groups comparable in terms of prevalence of all essential factors. In the study of randomized controlled trails, therefore all subjects hold an equal chance of being in the intervention or control groups. And this significantly adds to the merit of randomized controlled trails. Phenomenological research The phenomenological approach holds its unique focus on the illumination of the specific and identification of the phenomena through the mechanism they are perceived by the actors in a situation. On consideration of humans alone, this probably represents gathering of in-depth information and perceptions by means of inductive, qualitative methods and representation of the same from the perspective of patients. The methods used include interviews, discussions, and participant's observations. Thus, we may state that phenomenology deals with the study of experience from the perspective of the individual, bracketing of pre-accepted assumptions and perceptions. The phenomenological approaches can therefore be considered to be based on personal knowledge and subjectivity. They are therefore of vital importance in knowing of the unknown presence and reasons of a person's motivations and actions. Practice and knowledge of phenomenological research can therefore help fight the age-old basis of taken for granted assumptions. This means testing and evaluating a problem is crucial for acceptance in clinical practice since it guarantees a better quality of result. It is essential to note that pure phenomenological research holds its focus on description rather than explanation, and therefore begins from a point, which does not enfold any hypothesis or preconceptions in its womb (Husserl 1970). The birth of knowledge therefore from the pregnancy of phenomenological research is unexpected and not inclusive of any bias whatsoever. Many researchers hold a unique interest in a bias-free interpretation of the obtained results and participation of the participants as an essential practice (e.g. Plummer 1983, Stanley & Wise 1993). Varieties of methods that are used in phenomenological research include interviews (Measor, 1985; Oakley, 1981; Spradley, 1979), participant's observation, conversations, personal texts. This leads to the problem of large amount of data generation, which complicates the process of analysis. In order to analyze the data it is essential to first read the whole of it and thereby organize it. It is essential to identify important points in the text and then to organize them (Hycner, 1985). The method described in-depth by Hycner is essentially an important one in the organization of the unorganized and the briefing out of the huge material. The use of database as a means of collection of important information of the participants that form a great number is another important way of dealing with the not dealt problem of large quantity of data. One important issue in the clinical practice of phenomenological research is that there can be confusion between methods such as theoretical sampling, which is brought to practical application in order to be confident that participants are selected from larger area of concern. However, despite small roof areas for minor drawbacks, phenomenological approaches are efficient for in-depth knowledge of issues and providing a platform for being heard and understood. However, the applicability of phenomenological research is not of preference to the funding agents because of its job of exposure of the age-old assumptions as being valid or invalid in the dealt context. Thus, phenomenological research is an open challenge to the concepts followed and can therefore be considered as a very critical way of analyzing a thing. In clinical practice for the analysis of the drug, the phenomenological research might put to questions even the basic assumptions and shall deny accepting the hypothesis for example of the probably expected advantages from the drug entity. In the case of testing of synthetic drug, the experts many a times have a brief hypothesis of its probable action. For example, if a drug has been prepared in the laboratory as a synthetic derivative of an analgesic drug; then the point that touches the mind is its analgesic action The phenomenological if incorporated as an essential practice in clinical practice can certainly add to the reliability of the results. Advanced techniques available for data collection and analysis in the medical field can help overcome the problem of collection and analysis of large amount of data. In addition, with the acceptance of phenomenological research in clinical practice we shall certainly see a time of advancement of its usage by means of development of special software for ease of its application. Discussion Clinical practice constitutes the most crucial of all the steps in forming a new drug and enhancing the existent knowledge of a therapy or a therapeutic agent. The clinical practice being such an important component of any authentic research needs to be followed by the best and most efficient steps as possible. The randomized controlled trails have been considered efficient in providing the best quality of research results to the medical community. However, the acceptance of phenomenological research in combination with the randomized controlled trails too holds a base in the present context of subjecting even the most authentic thing to question before acceptance. The phenomenological research certainly holds a more concrete stand of omission of experimental bias by the rejection of assumptions and acceptance of complete participation of the participants. Study of drug molecules, especially in the allopathic discipline has been a common practice. Several studies designed by means of randomized controlled trials have been questioned by other randomized controlled trials studies. Thus, a data proved valid has been presented as being invalid in the results of other studies. We certainly need adoption of even better study techniques in order to fight the crippling disability of presence of bias in clinical trials. This insatiable need can be answered by the practice of phenomenological approach. Though phenomenological research shall prove to be more time-consuming and expensive as compared to that of randomized controlled trials, it shall assure better quality of results. The complete investigation of a new drug molecule takes about 12-14 years time and an expense of around $600 million dollars. A huge amount of investment of time and money go waste on the face of the failure of a drug molecule at the final stage or perhaps at any stage. In order to stop the rejection of the drug molecule, we need to develop an approach that is more fruitful in the long term of money and time investment. In addition, it is important to note here that phenomenological research is one such research that can show its existence in the challenging scenario of competitive research designs and methods. Another important point that needs consideration is that engagement of clinical trails with new and better study designs can help flourish the possibility of better study results. Thus, taking even a chance with other research methods that help provide even possibility of better results is of no harm to the health and well-being of clinical practice. In the case of clinical practice several assumptions are accepted for the confident prescription of a therapeutic agent. For example, a drug which has been found to be of therapeutic benefit in the treatment of say dementia of Alzheimer's disease in randomized controlled trials and has been approved by the legal authority governing its marketing and prescription attributes, is being prescribed to every patient with great confidence. Next, originates the need to answer the question, as to why drugs which have been approved and marketed later on gets rejected and are thereby withdrawn from the market of therapies and therapeutic agent This important question can be addressed only by the fact that clinical trials continue to progress in the quest to accomplish greater authenticity even after a drug is marketed. However, such a situation can not only result in loss in terms of time and monetary values but can also afflict a loss in terms of patient's health and sometimes-even life. For instance, Nimusulide has long been accepted in the market scenario as a pain relieving drugbut what the recent time has seen is its withdrawal from the market. Though withdrawal has been accomplished the harm caused by Nimusuidle to numerous patients cannot be reversed. We therefore recommend that phenomenological research should be used. This approach shall be better than even double-blind trials in case of authenticity generation. The assumption or hypothesis that might become the reason for bias shall be ruled out in this case. Conclusion We hereby conclude that randomized controlled trail though has been a method of choice since long in clinical practice holds some areas of bias penetration. In addition, this includes the incorporation of preconceptions and hypothesis. The phenomenological method of analysis holds greater efficiency to eliminate the probable incorporation of bias in any study. It is more a phenomena of challenging even the basic assumptions and holding no preconceived thoughts or ideas. Thus, the results obtained from the phenomenological analysis along with randomized controlled trials present a higher potential of reliability as compared to those obtained by means of randomized controlled trials alone. Thus, it is important that we do not hold an assumption or presumption in the knowing of the unknown. The practice of an assumption-free clinical practice can only be possible by the penetration of phenomenological research. References Lei, M. (1991). A randomized controlled trail of maprotiline treatment of depressive disorder. Zhonghua Shen Jing Jing Shen Ke Za Zhi, 24(5), 265-7, 316. Husserl, E. (1970). trans D Carr Logical investigations New York:Humanities Press. Hycner, R .H. (1985). Some guidelines for the phenomenological analysis of interview data, Human Studies, 8, 279-303 Measor, L. (1985). Interviewing: a Strategy in Qualitative Research in R Burgess (ed) Strategies of Educational Research: Qualitative Methods. Lewes:Falmer Press. Oakley, A. (1981). Interviewing women: a contradiction in terms in H Roberts (ed) Doing Feminist Research London: Routledge & Kegan Paul Plummer, K. (1983). Documents of Life: an introduction to the problems and literature of a humanistic method London: Unwin Hyman. Rohatiner, A., Radford, J., Deakin, D., et al. (2001). A Randomized Controlled Trail to Evaluate the Role of Interferon as Initial and Maintenance Therapy in Patients With Follicular Lymphoma. Br J Cancer, 85, 29-35. Spradley, J. P. (1979). The Ethnographic Interview New York: Holt Rhinehart & Watson Stanley, L & Wise, S (1993). Breaking Out Again: Feminist Ontology and Epistemology London, Routledge. Read More