Clinical Research, Clinical Data Management training

Clinical Research:

The National Institutes of Health [NIH] explains “clinical research” as study administered with human subjects or on elements of human origin like specimens, tissues, etc., for which a researcher interacts directly with human subjects. In vitro studies are not included in this as they are not linked to a living individual.

Clinical research comprises of clinical trials, which are investigations that analyze the efficacy and safety of medical devices or drugs. These investigations are carried out in line with a formal protocol, which categorizes what kind of patient can participate, what is being measured, when and how much treatment is given, and the overall duration of the study.

Clinical Trial Phases:

Clinical trials advance in phases, making headway toward use for patient care after the drug/device has been thoroughly studied for effectiveness and safety. The stages of clinical trials, which each new treatment must pass to be introduced into the market include:

In phase I, researchers would test a new drug/treatment in a small group of individuals to analyze its safety, ascertain a safe dosage range, and identify the side effects.

In phase II, the drug or treatment is administered to a larger group of people to analyze if it is efficacious and to further assess its safety.

In phase III, the drug or treatment is given to large groups of people to affirm its efficacy, check up on the side effects, compare it to the commonly used treatments, and gather information that will allow the drug or treatment to be used safely.

In phase IV, the studies are done after the drug or treatment has been distributed to collect information on the drug's effect in various populations and any side effects that are associated with long-term use.

Research Techniques Used in Clinical Research:

There is numerous research techniques used for clinical research such as descriptive, exploratory, and experimental studies.

Descriptive Research:

Descriptive research makes surveillance about patients or health-related conditions. Usually, this investigation includes a small sample of patients and intensively studies them to get an idea into the subject of interest. Some examples of these include qualitative research, case-studies, surveys, etc.

Exploratory Research:

Exploratory research probes patients or conditions that have not been widely studied. Exploratory research looks to explain or define a problem. Many a times, relationships or associations are looked for so as to better understand a disease or disorder. For example, a study may uncover a link between lifestyle factors and a particular disease. Examples that include such are case-control studies, cohort studies, pilot studies, and historical research.

Experimental Research:

Experimental research comprises comparing two sets of people. Commonly, one set of the people receive an intervention or treatment and the other set of people do not. The aim of this research is to figure the effect of the intervention. When randomization is used, these designs are seen as the "gold standard" in clinical research as the design permits researchers to rule out most, and maybe all, substitutive explanations regarding their results. An example of this is where a researcher may contrast a group of patients getting a placebo drug as against a group getting an experimental drug. If the two groups are comparable at the beginning of the study, any differences at the end of the study like improvement in the disease/disorder in the experimental group can be traced to the experimental drug.

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Clinical Data Management:

Clinical data management consists of entry, verification, validation, and quality control of data that is collected through the implementation of a clinical trial.

Advancements in the current biopharmaceutical field demand that clinical data management (CDM) is at the forefront, causing change, inspiring direction, and furnishing objective evidence.

Clinical data management needs to rely on a vast sphere of skills such as technical, scientific, project management, information technology (IT), systems engineering, and interpersonal skills to handle, drive, and offer valued service in managing data within the foreseen e-clinical age.

Clinical Data Management (CDM) is a vital stage in clinical research, which leads to generation of high-quality, reliable, and statistically good data from clinical trials. This helps to develop a forceful step-down in time from drug development to marketing. The team members of CDM are dynamically involved in all stages of clinical trial, from inception to completion. They should have ample process knowledge that helps uphold the quality standards of CDM processes.

Many procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at periodic regular intervals during a trial. In the current setting, there is an heightened requirement to improve the CDM benchmarks to conform to the regulatory requirements and stay in front of the competition through faster commercialization of the product. With the enforcing of regulatory compliant data management tools, CDM team can conform to these requirements.

Additionally, it is becoming compulsory for the companies to present the data electronically. CDM professionals should comply to appropriate expectations and define standards for data quality and also have the vigor to conform to the fast changing technology.

The CDM process, like a clinical trial, starts with the final product in the mind, which means that the entire procedure is planned in keeping the deliverable in view. As a clinical trial is projected to resolve the research question, the CDM procedure is designed to hand over an error-free, effectual, and statistically well-grounded database. To meet this aim, the CDM procedure begins early, even before the finalization of the study protocol.

The top 10 pharmacological companies listed in the Fortune 500 companies earn more than the rest of the 490 companies listed! Well, that surely tells the story! The future looks bright and promising for clinical research and clinical data management, and it would only seem prudent to give this career a thought.

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