Over the years, clinical research has undergone an evolutionary change, in terms of cost of research, technology used, and duration of the study.
Clinical research involves a thorough literature review that helps to collate information on studies that involve interactions with patients and diagnostic clinical trial data, in order to understand the root cause of a disease and its treatment. It is worth highlighting that clinical research involves two major steps, namely study design and study reporting. Further, study design involves three key steps, theoretical design, data collection design and statistical analysis design. Specifically, experimental or non-experimental data collection, sampling or census data collection, and temporal characteristics of the variables to be examined are all aspects of data collection design. On the other hand, study reporting includes guiding principles to carry out concise, explicit and elaborative research.
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- Planning Period: This parameter takes into consideration the time period that is required to draw up the protocol, as well as to define the objectives of the trial. It is worth highlighting that the period for planning a clinical trial can take up to a year.
- Duration of a Trial: It takes into consideration the amount of time required to recruit participants, as well as to monitor their reaction and survival rate.
- Comparability of Patients: It takes into consideration the comparability of enrolled patient population with respect to prognostic factors. It is worth mentioning that prognostic factors define the enrolled patient population, help to formulate the objectives of the trial, and provide better treatment strategies. These factors provide valid estimates of the differences in the given treatment and help to evaluate results across different studies.
- Treatment Allocation Ratio: This step helps to reduce bias, balanced comparison between two treatment groups and quantification of errors. It is worth highlighting that patients can be allocated to two different trials at the same time; however, in such cases, patients are usually allocated randomly in a 60:40 or 2:1 ratio.
- Use of Historical Control Group: Historical control group can be used to estimate model parameters during the research design phase, to modify a study, or to augment or replace a control arm. Most of the clinical trials include a control group of patients who have the same characteristics as the specially treated group; however, these patients are not administered with the drug / therapy treatment.
- Treatment Management: The treatment provided to enrolled patients should be administered equally, regardless of their treatment plan. Further, in each therapy group, patients should have the same criteria of response and toxicity.
- Ethical Considerations: Ethical concerns can arise at any point throughout the trial. It is worth mentioning that conditions under which a patient may be withdrawn from the study should be carefully examined, prior to the trial. Further, an international review board must approve all human-related research projects.
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