What is Clinical Research?
Clinical research is the method by which doctors uncover whether new treatments work. As a cornerstone of scientific investigation, clinical research enables doctors to discover whether new drugs, treatments or diagnostic methods are safe and effective for use by people living their everyday medical care routines.
Clinical research also helps translate basic laboratory science (done in laboratories) into new ways of preventing, diagnosing and treating illness. Clinical research includes clinical trials but also other forms of studies such as epidemiology, physiology/pathophysiology studies as well as health services studies such as education/outcomes/outcomes/mental health.
Clinical research organization involves people of all ages and backgrounds; participants can range from those healthy to those living with diagnosed medical conditions such as heart disease, cancer, arthritis or diabetes.
Clinical research participants help scientists and physicians create better medicines, vaccines and strategies to treat diseases more effectively – this would not exist without clinical research! For instance chemotherapy drugs, cholesterol-lowering agents, antibiotics or cognitive-behavioral therapies would not exist without it!
All clinical research involves some risk for participants. While the amount varies from study to study, no matter the type of investigation there are always rules in place to protect participant safety that must be strictly observed by researchers and their teams.
People considering participating in clinical research studies are provided with all of the information needed to make an informed decision and can discuss any questions or voice any concerns with members of the research team. Once they agree to participate, participants sign a written document known as a consent form that details what will happen during and post study participation.
What is a Clinical Trial?
Clinical trials provide the fastest and safest way of testing new treatments that may benefit people. Clinical trials involve testing medical interventions such as drugs, cells or biological products; surgical or radiological procedures; devices or behavioural treatments and more – while also measuring health outcomes like pain relief and improved quality of life.
Clinical trials are overseen by a medical research team led by doctors, who closely monitor them for safety and efficacy. Trials follow guidelines called the Clinical Trials Protocol which detail experimental design, sample size, procedures to be adhered to as well and approval. It must be approved before starting.
Clinical trials consist of four phases. In phase one, doctors administer new treatments to a small group of people for testing purposes to monitor any possible side effects and assess safety. Phase two entails researchers comparing this new therapy against existing ones to determine which one is more effective, and finally phase three involves enrolling more participants while continuing to evaluate safety while measuring effectiveness.
Importantly, taking part in a clinical trial does not replace regular visits to your healthcare providers and you should follow their advice in terms of scheduling visits for optimal health. People participate in clinical trials because standard treatment options have failed them or they can no longer tolerate the side effects of current therapies, or simply contribute to medical advancement.
No matter the motivation for volunteering, all volunteers should understand that they will not receive comprehensive or long-term health care as part of a study. Johns Hopkins Medicine’s Research Participant Advocacy Program strives to keep participants well-informed on the roles they play in research studies.
What is an Observational Study?
Observational studies, as a non-experimental research method, involve collecting data through direct observation in real-world settings. They can be utilized for social science research – for instance, observing single parents raising children in unsupervised settings – or medical research when conducting controlled experiments would be unethical (for instance testing lifesaving drugs during public health crises).
An observational study is one in which researchers do not intervene or manipulate participants in any way, which allows the researcher to observe relationships between variables without needing a control group and can be used to uncover patterns or themes for further exploration. An observational study can also help get an idea of whether a new method or treatment might work by watching participants’ reactions and behavior over time.
There are various kinds of observational studies, including case-control, cohort, and cross-sectional designs. One advantage of observational designs is that they don’t rely on participants being subjected to any manipulation; making them more ethical than experimental designs. Unfortunately, observational designs may be difficult to interpret due to risks involving confounding variables and observer bias that make interpretation challenging.
Observational studies can be more time-intensive than other research methods, especially longitudinal ones that follow participants over extended periods. While this might cause concerns among researchers, it’s essential that when selecting an observational study type to consider your research questions.
Observational studies can produce invaluable results when applied to certain kinds of research questions, yet do not serve as definitive proof of causality; rather they’re best used as supporting research or preliminary data for more rigorous experimental designs.
What is a Case-Control Study?
Case-control studies are analytical observational studies that compare risk factors associated with the disease among those who did and didn’t develop it, such as investigating food-borne illness on cruise ships. Case-control studies can be more convenient than cohort studies since they require less time and resources to complete. Unfortunately, they’re also more prone to bias because data must be gathered retrospectively – taking longer for subjects to develop disease before providing information about exposures and providing data collection information about themselves.
Case-control studies use two groups, cases (people who experienced the outcome) and controls (those similar to cases but without disease), in an attempt to create an equal comparison group. Once constructed, researchers look through historical information for both cases and controls to identify any common exposures which could help pinpoint whether any risk factor studied might have anything to do with either disease or outcome.
One advantage of a retrospective cohort study is its ability to investigate rare diseases, as accumulating enough incident cases is often difficult in an exhaustive prospective cohort study. Furthermore, retrospective cohorts can also help when the disease has an extended incubation or latent period, where people may be exposed but don’t become sick until much later.
One drawback of this type of research study is the researcher must collect information about exposures from both cases and controls, which may cause recall bias; recall bias occurs when patients recall more details about past exposures when sick than at other times; randomization cannot be used either, which reduces internal validity.
What is a Randomized Controlled Trial?
Randomized controlled trials (RCTs) are among the most rigorous forms of scientific experimentation, serving as the gold standard in measuring interventions’ effectiveness.
Under randomized controlled trials, people are divided into at least two similar groups; the researchers then compare results between groups to determine if the new treatment has any effectiveness.
An optimally designed trial allows differences between groups to be directly attributable to the intervention being tested, rather than other influences. Randomized controlled trials are considered an ideal means of evaluating interventions in many fields including medicine, public policy and psychology. Clinical Research is the foundation of medical progress, encompassing clinical trials, observational studies, case-control studies, and randomized controlled trials. Spinos, as a Clinical Research service, plays a pivotal role in advancing healthcare by ensuring the integrity and effectiveness of these research methodologies. Trust Spinos for comprehensive and reliable Clinical Research services