Clinical research examines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. It involves conducting studies with real people enrolled as subjects; such studies can take place in hospitals, clinics, universities or over the Internet.
Clinical research requires participants of various ages and health conditions. Furthermore, diverse backgrounds must also be represented to obtain an accurate picture of how an intervention will impact all populations.
Research Ethics
Research ethics is a broad subject area that encompasses protecting both human and animal subjects, handling personal information responsibly and upholding intellectual property rights. While different approaches exist for research ethics, among the more popular are protecting the privacy of participants, providing informed consent, clearly defining risks, and ensuring all risks are communicated to participants. Research ethics also incorporates fairness–ensuring all relevant information reaches all individuals involved and any conflicts of interest are mitigated promptly.
Clinical research involves conducting medical trials with humans to explore potential new medical interventions. While doctors can conduct drug trials on laboratory animals, before making them available for patients they must first put them through human testing. Computer models may eventually enable clinicians to compare clinical benefits without needing human trials, but until that day arrives potential new medical procedures must first undergo testing by humans.
As such, clinical research represents a central ethical challenge, in deciding when it is appropriate to expose some individuals to potentially harmful risks to benefit others. Due to Nazi physicians’ abuse during World War II and the thalidomide disaster in 1962-63 as well as subsequent recommendations in the Nuremberg Code that provide guidelines for research subjects (Grodin & Annas 1996; Shuster 1997).
The code stresses the need to protect research subjects from physical or psychological harm, discrimination or deception during studies. Researchers must disclose all risks of participation before beginning any trial and inform potential participants about any additional procedures or tests outside the scope of the trial. They also must obtain written consent before proceeding with research activities.
Rules exist regarding conflicts of interest and how financial relationships between researchers and sponsors or collaborators are managed, which must be strictly observed to maintain integrity in research and to avoid prosecution for fraud or other crimes. Failure to follow these regulations could have dire repercussions for research ethics – for instance, a researcher failing to disclose potential conflicts may risk losing funding while failing to report ethically questionable experiments could incur jail time for both them and any collaborators or sponsors involved.
Research Design
Research objectives that are set and relevant are essential for conducting successful clinical research. Such objectives should address all five ‘W’s of research: who (participants); what (medical condition/disease/infection/toxin); why (why it’s important to investigate); how (how the investigation will be conducted); and where (which geographical areas are relevant). Using a population, exposure, comparator, and outcome approach helps the researcher shape these objectives more easily.
Researchers must also take into account all available study designs when devising their research plan. Each has its own advantages and disadvantages; experimental studies, for instance, use variables under controlled circumstances while descriptive ones observe natural events without alteration from outside forces; experiments require extensive data collection for scientific conclusions while descriptives offer more descriptive information and may cost less money to implement.
Researchers must also have an in-depth knowledge of research ethics to conduct clinical trials safely. This includes understanding all applicable laws about this form of investigation as well as the ethical considerations involved. A clinical researcher must possess this information so they can ensure participants’ well-being during trials.
Communication between clinical researchers and the general public regarding research efforts is also essential to building trust with participants and increasing the likelihood of informed consent being received from participants. Recent studies on this subject have examined various methods for increasing informed consent rates among low and middle-income countries.
An effective clinical researcher must also be capable of effectively leading a multi-disciplinary team, which requires strong leadership abilities as well as an understanding of setting clear expectations and goals for team members. Furthermore, researchers must negotiate with stakeholders to find common ground and reach a consensus decision.
Learners have gained a strong grounding in clinical research principles, and are ready to move on to the final module of this course. During this module, learners will be introduced to the FDA’s structure and jurisdiction as well as IRBs. In addition, the course will examine how clinical investigations support FDA marketing applications by providing evidence that a new drug or device is safe and effective.
Research Methods
Research methods refer to the methods and processes employed when conducting studies, collecting data, and interpreting results. Clinical research involves applying these scientific techniques to create, test, and improve medical treatments; this type of research includes basic laboratory investigations, animal testing trials, as well as human studies with the ultimate aim of adding to the body of knowledge surrounding disease or condition.
Clinical research can be carried out by doctors, nurses, social workers, and other healthcare professionals as well as scientists, data managers, and other staff members. Participating in a clinical research study should be treated with great care; to make an informed decision it’s recommended that potential participants review the National Institutes of Health Clinical Research Trials and You website as well as consult their health care providers and family to understand risks and benefits before joining a study; participants also need to keep in mind they can opt-out at any point during participation.
Clinical research begins with laboratory studies, followed by animal trials before moving on to human trials. Before being approved for use by the FDA for use on patients, any treatment must undergo intensive clinical testing and evaluation by trained researchers in its final phase – such as how well it treats disease symptoms, any side effects it causes, and its overall safety profile. Usually experienced practitioners conduct the final phase of trials successfully.
Clinical research can serve many different purposes. One type is meant to compare medical strategies and treatments – this form is known as controlled clinical trials – this form is crucial in testing new drugs, biotechnology products, diagnostic assays, and medical devices before their approval process begins. Most trials will include both experimental treatments (those being tested) as well as existing therapies – researchers then compare results between groups to determine whether a new treatment is both safe and effective for human use.
Observational studies are another form of clinical research that employs people in their natural settings to gather data. For example, researchers may ask older adults about their exercise habits or give monthly memory tests to monitor their impact on cognitive health. Such observations provide invaluable information that will aid future studies.
Research Results
Clinical research studies aim to provide healthcare providers and patients with information to make more informed healthcare decisions, often through volunteers like you who voluntarily take part. Clinical trials can show whether new medical strategies, treatments, or devices work for specific illnesses or populations of people.
To ensure research results are accurate, impartial, and useful, it is critical to follow proper research methodology. This means using clear language when explaining research methods used and data collected as well as avoiding biased reporting or selective reporting – this process is known as transparent research – an integral aspect of good scientific practice.
Successful clinical researchers possess a broad set of abilities necessary for deliberatively reviewing the medical literature and translating it into real-world action steps for patients, including epidemiology, biostatistics, study design, ethics in research, evidence-based medicine, and communicating research findings.
Trust building with participants when recruiting them into clinical trials is also essential, which involves explaining clearly why they may or may not qualify, while keeping open and honest communication channels throughout the research process.
As medical science progresses, clinical research faces increasing challenges. Funding is often limited and the quality of research varies significantly across nations due to difficulty in striking an equilibrium between patient safety and expanding medical knowledge.
Research must be relevant and applicable to healthcare professionals, patients, and the general public. One way of doing this is by exploring experiences of healthcare professionals regarding the implementation of research results into their daily clinical work using qualitative methodologies such as interviews, focus groups or questionnaires. One such study asked healthcare professionals to identify existing methods of incorporating research results into daily healthcare actions categorized into six main categories – non-formalized, consensus-oriented problem oriented autonomous knowledge-based.
