Clinical Data Management

Clinical Data Management

Published On April 05, 2016 -   by

How Statistically Sound Data Affect Public Health

Data entry has widespread appeal for a variety of business types and is implemented in nearly every genre on a global scale. While it is commonly understood to be a means of managing information and staying organized, it also has applications in more unusual fields, such as those who focus on research and related studies. Clinical Data Management (CDM) is a scientific based field that helps develop advanced means of using information based upon findings gathered from clinical trials. Data is collected, integrated, and then conclusions are drawn based upon the facts scientists and other academics glean from this excessive amount of information. The data generated from these trials help assure that the gathered information is reliable, and statistically sound. The National Institutes of Health ensures that the conclusions drawn from clinical research is supported by sound, fact based data. Their main goal for such vigorous attention to the facts in clinical research is to ensure public health and confidence remains intact in marketed or targeted areas.

Data entry is the vital core for CDM, as all aspects of this field revolve entirely around the information that is gathered and utilized for different types of clinical trials. Data must be correctly collected, validated, completed, and above all, consistent. Misinterpreted or missed data can have a chain reaction, negatively and inaccurately affecting everything else in its wake. As public health is a top concern for both the government and the National Institutes of Health, having correct, proven data is a necessity in order present clear findings, create and market new medicines, and find innovative solutions for treating and preventing existing conditions.

Data Entry and Drug Development

The development and marketing of new prescription and over the counter drugs is a leading factor in medical based clinical research and the many facets of data entry become a means of producing information and results quickly. As clinical researchers are tasked with using data in ways that lead to scientific findings, different data based procedures are employed across the spectrum of the clinical research process. Case Report Form designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. Research clinics and labs are required to submit all findings electronically as this sets a standard for data quality that helps labs adapt to rapidly changing technology.

Data that is processed electronically can be analyzed according to stricter, unerring programs that can help scientists study information and compare it to a wide range of other facts, including new or old information, hypothetical data, or data acquired from other clinics and databases from around the world. Clinical trials are intended to find answers to questions generated from data, and either proving or disproving those findings. Having quality data ensures that the outcome of the study is always valid. When developing new drugs, quality data is an absolute, as the regulatory agencies must approve of all drugs being released to the public, and are notorious for having strict standards with regards to medications. Additionally, clinical trials are often a sole means of determining if a drug in the process of development is able to potentially be marketed and released.

How Data is used by Clinical Researchers

Data used in clinical trials must be collected first, usually from test fields, whether it’s in a medical facility with patients undergoing untested new medical treatments, or from studies involving chemical compounds in a pharmaceutical lab. This collected data is then cleaned according to a set, predetermined standard according to the objective of the trial. This process removes all unnecessary, excess data that does not affect the clinical trial, leaving only the relevant information that can be easily utilized by scientists and researchers. Finally, the data is analyzed and managed in different ways, stressing the importance of ensuring that the data is kept clean and well organized within an automated software program or database to keep the number or errors as low as possible. Modern, sophisticated software applications utilized in clinical trials maintain an audit trail and help provide easy identification of the data, even in large scale or complex clinical trials. Occasionally, regulatory personnel are required in later stages of a trial to further ensure that data is intact, and any missing data is recovered and applied correctly. As regulatory requirements set by various government and multi-national commissionaire boards are typically strict, it is essential for clinical trials to follow undeviating protocols in order to remain functional, and eventually pass findings, medications, and other material on to the public.

One way that data entry is being carefully managed within clinical trials is by applying Clinical Data Management Systems, which are basically software tools that use a highly sophisticated information technology infrastructure to function. Depending on whether a pharmaceutical company is commercial or not, for example, may affect the type of program used. Either way, these data management programs are always custom designed, carefully regulated, and help prevent discrepancies of all kinds that can lead to faulty trials, or even in a worst case scenario, complete shutdown of a clinic. The data is only as beneficial as the people who control it, thus these programs also allow labs to limit access to data in areas like data entry, medical coding, or final quality checks.

Clinical Trails, Data Management, and Public Health

Public health is affected by clinical trials in undeniable ways, as having access to medications, case studies, patient care, and more is often tied to research conducted during clinical trials. Developed countries generally have more access and availability of cutting edge medications, vaccinations, and preventative measures than undeveloped or third world countries. Clinical trials, often conducted by private and public pharmaceutical companies, find more funding, test subjects, and access to necessary technology and data in developed countries. Ensuring that communicative diseases and related issues are treatable is an ongoing concern for most governments, as the spread of certain medical conditions can quickly lead to larger, more difficult issues. Public health must be maintained, and clinical trials help provide a means for people to stay healthy, treat existing conditions, or prevent possible diseases and maladies like polio, measles, and smallpox.

Data usage in clinical trials must follow certain protocols to ensure information remains untainted throughout the duration of the trial. All data must be handled with integrity, and all involved staff member must be qualified, trained, and able to perform their tasks flawlessly. In a few cases, mismanaged data within a clinical trial has led to the release of harmful drugs such as Cylert, used to treat ADHD and ADD, which was on the market for 30 years before it was pulled from the market for causing liver toxicity. Vioxx, a pain reliever, was available for five years, and was highly promoted by athletes like Dorothy Hamill and Bruce Jenner, before being pulled for links to sudden cardiac arrest. There are thousands of similar drugs and similar instances of these drugs being pulled for various reasons, all of which negatively affected the health of those using them. In the two specific cases mentioned above, it was due to clinical trials not being performed properly or thoroughly enough, a result that leads back to lack of sufficient data, or misinterpreted data. It is integral, for the sake of public health and well-being, that clinical trials are conducted with every attention to detail, and a painstakingly accurate approach to data usage.

Unfortunately, it is all too common to see cases where medications have led to further medical complications or death. Yet the regulation of clinical trials continues to be fiercely monitored in most instances, leading to the production, development, and marketing of innovative, beneficial new medications and treatments for a variety of illnesses. As each year provides leaps forward in technologies, clinical laboratories can integrate cutting edge software programs that help keep data accurate, trustworthy, and of the highest quality so that analysts, scientists, and medical researchers are able to conduct the appropriate tests and studies on their collected data.

Data Entry for Clinical Studies

The data utilized within the process of clinical trials, such as database designing or data validation, are part of a larger area of data entry that is vital to the function and purpose of all clinical trials. Just as test subjects are a fundamental means of acquiring information for researchers, the related data is fundamental to the actual process, and all results obtained. Collecting, cleaning, analyzing, and finalizing databases involves data entry in its purest sense. Information that is recorded and used by researchers makes the various developments and advancements in science, medicine, and technology attainable, and extends that positivity to the public for the betterment of their collective health.

– DataEntryOutsourced

Related Posts