Unraveling Mysteries – The World of Clinical Research
No matter their goal–from tracking down criminals to curing cancer–researchers use various methodologies to uncover mysteries and gain new insights. In this episode of Unraveled, we investigate some of these techniques used by researchers.
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Methodologies
Clinical research organization is an integral component of medicine. It applies basic research conducted in labs into new tests and treatments designed to improve people’s health. Clinical research may involve trials involving drugs, cells and other biological products; surgical procedures; radiological techniques; devices; or behavioral treatments that aim at bettering wellbeing for humans.
Clinical research requires voluntary participant engagement; either due to having a specific illness, or upon their doctor’s suggestion. Once accepted into a study, participants are monitored closely throughout its duration; should they wish, they are free to leave at any point and can even opt out. Studies may last from several days up to several years depending on its scope and length of participation.
Clinical trial results provide researchers with vital insights into the causes and treatments for disease while helping determine whether certain drugs, treatments or devices are safe, effective and have side effects. Clinical trials can take place anywhere from hospitals and clinics to research centers and universities, at home or over the Internet.
Participation in clinical research should always be a personal choice, made after carefully considering risks and benefits. The National Institutes of Health’s Clinical Trials and You website can be an excellent source of information to make this choice. In particular, its list of questions about joining studies provides people with a useful way to ensure they remain fully informed if invited to join one – helping reduce barriers associated with clinical research participation.
Data collection
Data collection methods used in clinical research can range widely, from surveys or questionnaires, qualitative interviews or focus groups; observations made using sensors, scales or lab equipment, audio/video recordings or even corpuses of text. Selecting the most effective data collection method depends heavily on each study’s objectives and should always be carefully considered before selecting its data collection approach.
No matter what form of data collection, a clear protocol description is crucial for effective implementation and reviewers assessing appropriateness. Forms used for collecting the data should also be clearly specified within each protocol document as should the personnel responsible for filling them in and procedures for reporting discrepancies in data. Pilot tests as well as detailed evaluation of reliability and validity must also take place.
Data collection in many studies used to be done manually using paper Case Report Forms (CRFs), however in recent years e-CRFs are increasingly replacing paper forms due to electronic entry of data that allows easy backup and storage. Unfortunately, staff in health care entities may still be reluctant to implement these systems due to cost and other concerns; some staff even believe that collecting this type of information is unnecessary and may offend patients (Nerenz & Darling 2004).
Analysis
Clinical research involves testing new medications, medical devices and procedures on humans in order to evaluate their safety and efficacy for human use. This requires conducting rigorous experiments in controlled settings known as clinical trials. These trials provide invaluable results that can be used to either enhance existing treatments or create entirely new ones. Clinical research can take years and is conducted in several stages, covering treatment, prevention, diagnosis and screening research projects. Treatment research addresses specific disorders or health conditions using medications, psychotherapy or surgery as treatments. Prevention research seeks to prevent new or returning disorders through medicines, vaccines, vitamins or lifestyle modifications; while screening research uses blood tests or imaging scans as diagnostic tests.
Analysis of clinical data generates large amounts of summary statistics and model predictions; however, these analyses are often not recorded as independent sources for reuse due to regulations prohibiting sharing individual patient-level data. One way of solving this would be recording these analysis results as standard datasets so researchers could “calculate once and use multiple times”, helping reduce repetitive manual processes as a result.
Interpretation
Interpretation is an integral component of clinical research. It involves making sense of raw data and turning it into usable insights to enhance patient outcomes and quality of life, as well as communicating these insights to others. Understanding the difference between interpretation and translation is crucial; both processes involve communicating ideas and concepts but differ in various ways.
Clinical research requires much paperwork and preliminary work, known as planning stage, before commencing actual research. This phase includes identifying a problem, searching for relevant literature, formulating hypotheses, creating study designs, and forming collaborations.
Before embarking on a clinical trial, researchers must ensure all the required information has been gathered and analyzed – this can be accomplished with a protocol, or standard operating procedure documenting this information and making sure they can be reused again in future trials.
People often confuse clinical research with medical care. A healthcare provider typically creates an individualized treatment plan for each of his/her patients, while researchers typically follow a set protocol. They cannot adjust this protocol based on who is involved or changes can only occur with approval by all parties involved and outlined steps must be taken if someone’s health does not improve as planned.
