Clinical Research is being done to extrapolate, explain, and explore various medical concerns through data and experimentation. Basically, the objective of a Clinical Research is to answer a medical inquiry, concern or an unmet medical need. However, Clinical Research or Clinical Trials can also discuss the improvement of treatments, effectiveness of medications, and cost-efficiency of devices. Clinical research is a vital part of society’s health safety and welfare as it addresses current and future medical risks that might lead to potential medical crises.
Clinical Research Factors
Topics of a Clinical Research can originate from personal ideas that relate to a given situation or natural processes and phenomena. Since the process of medicine in itself is a continuous development and error-correction, Clinical Trials must be able to obtain an “experience from experience”. To explain further, one strange case can pose many problems and raise questions that need to be investigated and further studied. So, to understand a unique phenomenon, reflection, analysis, identification of theoretical framework, and application through experimentation would be executed to extrapolate, explain, and explore a clinical concern
I. Choosing a Topic
Choosing a Clinical Research topic can be out of personal interest or a societal health issue. Whatever the case maybe, Clinical Research or Clinical Trials are important as they tackle potential health risks: diagnosis, management, and treatment.
By the virtue of its nature, Clinical Research is more than just data collection and interpretation. In-depth analysis from different sources is a good way to have an opportunity for better learning and improving patient’s health. These are some tips on how to decide on a Clinical Research topic.
Michael D Fetters, in the article “Getting Started in Primary Care Research: Choosing Among Six Practical Research Approaches”, explained that a Clinical Story is the narration of an incident or a series of events that took place at a certain time that a primary care provider observes but doesn’t understand. The story or anomaly gives way to Clinical Research ideas and questions.
In the same aforementioned cited article, Fetters said that these stories or narratives can come from colleagues, staff, or even specialists in the workplace. In addition, Clinical Stories can arise or develop within specific settings like hospitals, long-term institutions, home care settings, or even during training of medical students.
Retrospective vs Prospective
Retrospective studies are performed using the data that has already taken place. Retrospective studies require less time to be executed and don't need to keep track of the patients in the future. This type of study is faster and inexpensive as compared to Prospective studies. Also, Retrospective studies help to predict the likely outcome of a disease and the therapeutic strategy that is applicable to it based on the predicted risks.
Prospective studies, on the other hand, investigates and observes the development of a disease or case over a significant amount of time. Also, a Prospective study relates other factors such as risks and protection. In comparison to Retrospective studies, Prospective studies have fewer possible sources of bias. Prospective studies make precise estimation of an outcome or risks that comes with the exposure of the result.
II. Collection of Data
Without data, there is no new knowledge generated (Toten, Simon, Jalili & Sawe, 2020). Since Clinical Research requires data and experimentation to answer clinical questions and concerns, new knowledge is being acquired every time a study is being conducted. The information would help shed a light to a formerly unexplored phenomena or guide future research towards a certain goal.
Saczynski, McManus, & Goldberg, in their manuscript “Commonly Utilized Data Collection Approaches in Clinical Research (2013)”, states that, survey questionnaires, self-reported patient data, proxy or informant information, medical records, collection and analyses of biologic samples are commonly used to gather information for Clinical Research.
CRF (Case Report Forms)
Case Report Forms, or CRF, is a specialized document in Clinical Research to collect and study data. It can be used to gather primary, real-time, data or secondary (originating somewhere else, e.g. EHR or Electronic Health Record and paper record) data. The primary purpose of CRF development is to preserve and maintain the integrity of data as Bellary, Krishnankutty, & Latha mentioned in their paper entitled “Basics of Case Report Form Designing in Clinical Research (2014)”.
Furthermore, the paper pointed out that CRF should have a clean lay-out, be well-formatted, and standardized so that the personnel in-charge with handling the collected data, for example the investigator and data manager, would have an easy time examining them. This would greatly improve the productivity of an on-going Clinical Research or Clinical Trial. In short, CRFs should be user-friendly.
PRO (Patient Reported Outcomes)
Patient Reported Outcomes, or also known as PROs, are data given by the patients gathered electronically or traditionally (paper and pen). Data found in PROs are from questionnaires or journals. Some benefits of PROs are higher quality of data and less workload on the staff working on a Clinical Trial or Research.
PROs may improve the quality of production in a Clinical Research, but some notable disadvantages can also be pointed out especially in ePROs (Electronic Patient Reported Outcomes). One is the required technical effort of data submission. Some people, especially the elderly, would be having a hard time navigating electronic tools to send or store their data. Also, network lines should be readily available.
III. Credible Sources
Clinical Trials, being still a research, needs to have validated and unobscured data. This means, all of the information that should be presented in a certain study has to be true, verifiable, and credible. Aside from citing past but relevant research and official medical records, the internet is also a very convenient tool for gathering information. However, some of the information found online is not reliable. So, a researcher should be extra careful on examining which information should be used or not.
Website Hosts or Sponsors
Since websites require money to set-up and run, it is imperative to know who manages it to ensure or at least have an idea about the site’s agenda. Sometimes, the address or URL of a website could be helpful for judgment. Some examples would be:
- .gov for US agencies
- .edu for Educational Institution (universities, colleges, schools)
- .org for non-profit organization (professionals; scientific, medical, and research groups)
- .com for commercial websites (pharma or hospitals)
Also, examining the author, the author’s credentials, date of publication, reviews, privacy protection, should be carefully considered when going through a website.
Sometimes, the motive of a certain website would be obvious if some personal and sensitive information should be provided in order to access the site. Also, if a site requires to get information from a computer or download a file to it, a site could be more likely not trustworthy.
Role of CRA in Clinical Trials
CRA (Clinical Research Associate) is responsible for coordinating and supervising Clinical Studies with medicines, nutrition and devices. In addition to that, CRAs may also be contributing of patient-related tasks such as selection, initiation, and visits in centers for Clinical Trials. CRAs also manages source data verification and ensures that the study is being carried out in accordance with the existing laws and regulations and company SOPs.
Starting a Clinical Research is a serious and difficult decision to make. However, no good effort goes to waste. By conducting or simply participating in a Clinical Trial as a staff, a person can have a significant amount of experience that can further improve one's curriculum vitae, credentials, and value. On the other hand, the information brought to life by Clinical Research would help the society understand Medical Concerns more. So in the end, it is still a win-win situation to spend a lot of time and energy participating in Clinical Research.