The Methodology of Research
The methodology of research is critical as it enables the reader to assess the overall validity and robustness of a study.
The methodology of research is a term that refers to the direction or path scientists take in order to conduct their research as they devise their problem and objective and ultimately present their findings from the data that was collected over the course of the study period. More specifically, the methodology highlights the procedures or techniques that are utilized to identify, select, process, and analyze a topic. The methodology section of the research is critical as it enables the reader to assess the overall validity and robustness of the study. The section addresses two questions, namely the way in which the data was collected and generated and how it was analyzed. It is typically subdivided into sections such as study area as well as primary and secondary data sources.
The Importance of a Double-Blind Placebo
Among the many circumstances under which a research methodology is designed, one of them is a way to test the effectiveness of an intervention. In this context, it is common to have two groups of cohorts, or individuals, one of which receives the drug of interest and the other one receives a placebo. A placebo is an “inactive” intervention that replicates the active intervention such that an individual is unable to tell if they are taking the active study product or the placebo. The data collected from the intervention is then compared between the two groups. Within that study paradigm, there are several types of studies that researchers can implement as part of their testing approach, one of them being a double-blind study. In this procedure — often regarded as the gold standard for intervention-based studies — everyone is blinded, meaning that the participants as well as the experimenters do not know who is receiving the active intervetion and who is receiving the placebo. This approach prevents bias in research results that can come from demand characteristics or the placebo effect.
The two most important reasons behind conducting a double-blind study are (1) so that the participants are uninformed about what they are given, and thereby are not biased in their beliefs about the intervention and the outcome, and (2) to keep the researchers unaware of who among the subjects is receiving the real intervention and who is not, thereby ensuring they do not give away any clues to the participants or bias the interpretation or recording of the study data. Regarding the second reason, it is also helpful to blind researchers so they are completely objective when collecting and analyzing the data (which is not easy to do when information regarding the two cohorts is known, or unblinded). This is called experimenter bias.
Starting a Clinical Trial
A clinical study or trial involves a group of human volunteers — or participants — who are engaged in a research study that aims to test the effectiveness of an intervention on a particular outcome, like a disease. Participants are given an intervention in accordance with the research aims or protocols that have been designed by the principal researchers. A trial either compares the differences between an established or a new protocol or a placebo (containing no active ingredients). In the case of a new product, things like effectiveness, efficacy and whether it is better than anything that is available on the market are not known, and a clinical trial helps elucidate that information.
Starting a clinical trial is a large endeavor with several factors involved. Overall, there are six things to consider when starting one, and these include:
- Proper selection of countries and sites
- Determining internal collaborators and whom to work with
- Taking into consideration both budget as well as regulatory requirements
- Designing the best protocol with specific endpoints that will be measured, including how those endpoints will be analyzed
- Choosing the most appropriate external collaborators
- Establishing auditing methods to ensure procedures take place as planned
Key Steps to Ensuring Accurate Results and Data
Accurate results and data are fundamental to research outcomes as their analysis determines the results of a trial. As such, ensuring that data collection and analyses are as accurate as possible should be at the heart of the research methodology. There are key steps that can be taken toward that end goal, and these include the following:
- Establishing aims and goals
- Understanding outcomes (through hypotheses)
- Eliminating research bias
- Choosing appropriate research methods
- Including the most relevant subjects/participants
- Understanding the audience and knowing the context
- Determining the appropriate measurements of those outcomes
- Determining the most appropriate analysis of those measures
References
https://www.verywellmind.com/what-is-a-double-blind-study-2795103
https://clinicaltrials.gov/ct2/about-studies/learn
https://www.invespcro.com/blog/9-tips-to-conducting-accurate-qualitative-research/
