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What is Clinical Research?
Clinical research refers to the study of human health and disease. We can study medicine at many levels. For example, the bacteria that cause disease can be viewed through a microscope and studied, or researchers can use mice to study a disease process that affects humans. The key feature of clinical research is that it involves the study of humans.
What are the different types of Clinical Research?
Human studies can vary depending on what the researchers are interested in learning. Types of clinical research include:
- Treatment studies – evaluating which medical interventions work best for a disease
- Prevention studies – evaluating how to prevent a disease from starting or progressing
- Diagnostic studies – evaluating how best to reach a medical diagnosis
- Genetic studies – evaluating which gene(s) cause, or increase risk for, a disease
- Epidemiological studies – identifying patterns, causes, and control of a disease
Over the years I have noticed that consumers have a very difficult time understanding the quality of a scientific report, whether it is a book, a magazine or journal article.
Scientific knowledge is based on incremental progress derived from hypothesis and experiments that get replicated enough to become common knowledge. This is a slow process. The scientific world is full of ideas that lead into hypotheses, many of which cannot be proven or even put into an experiment. So, where is the starting point? Well, with hypotheses and experiments that conducted and made public. A peered-reviewed scientific journal article is a body of work originated in a hypothesis, that presents methods, results, discussion and a conclusions, that are “validated” by experts in that particular field of knowledge. This method of assessing scientific information is geared to improve quality and reduce bias (we all “fall in love” with our experiments and have a tendency to not see embedded problems in our work).
The peer-review system works following way (simplified):
- An author or group of authors generate a written report of a specific area under study (a paper).
- The paper is then submitted for publication to a peer-reviewed journal.
- The journal editor picks anonymous experts that would read the paper and provide feedback to both the authors and the editor about the quality of the work and possible changes that could be made to the paper under review to improve the scientific content (e.g.: additional experiments, rephrasing certain statements, etc).
- The reviewer also provides suggestions to the editor that might range from “accept the paper,” to “reject” this body of work as it is presented if modifications are not made, or reject it altogether (regardless whether modifications can be made).
- The proposed modifications may or may not be accepted, and finally
- The editor decides whether the paper will be published or not in her/his journal. This type of publication is what I would refer to as a journal article.
On the other hand, we have magazine articles. These reports usually would not have been reviewed by experts, thus, the writer holds the power to check statements presented as “facts.” In this situation, the writer might introduce voluntary or involuntary bias, reaching conclusions that are not necessarily supported by data. Finally, we have books, the lowest form of scientific information. Why? Because anyone can publish a book and say whatever they see fit. Often, books with scientific themes would include references. These references could indeed support statements made, but sometimes those references are unreliable and biased themselves. The problem is that we ultimately have to trust the author about the statements contained in the book and bias may be rampant.If an article is peer-reviewed, does it guarantee the content is accurate?? No. The peer-review system is not perfect either, it’s the best we have. Validation of certain claims may take many years to be verified, it’s replication of the same experiment that increases confidence in a certain finding.The dissemination of scientific information is not a simple issue. Scientific reports may drive significant amounts of money and power, thus, the risk of bias is always present.
There are several ways that researchers identify people who are eligible for a research study. Large studies might advertise in the newspaper or on television. Researchers from smaller studies typically identify patients from medical clinics, emergency rooms, or hospitals. Patients are individuals who have the disease or medical condition being studied. Healthy individuals also can be eligible for clinical research. There are several ways that a researcher might identify a group of healthy individuals for a study. Research eligibility means that an individual fulfills the specific study criteria for participation. For example, in a study of blood pressure changes with pregnancy, researchers might be looking for women (1) in the first trimester of pregnancy, (2) at least 18 years of age, (3) without prior high blood pressure, and (4) without other medical conditions. A woman meeting these criteria would be considered eligible for research.
Several rules are in place to ensure that humans who participate in clinical research are treated ethically. At the core of these ethical rules are two basic principles: researchers must (1) do good (known as beneficence) and (2) do no harm (known as non-malfeasance). There are research ethics boards that approve, review, and monitor human research to ensure that these principles are upheld. In the United States, they are called Institutional Review Boards (or IRBs).
Informed consent is part of the ethical approach to good clinical research. Informed consent means that research participants (1) should know that they are participating in research and (2) should be informed about what will be expected of them. Once researchers identify an individual who is eligible for their study, the process of informed consent follows. Informed consent should include a verbal description of the study, a written description of the study (that is signed by the participant), and an opportunity to ask questions. Researchers cannot force individuals to participate; access to medical care cannot be used to encourage participation; they must make an effort to keep participant information confidential; and they must inform the participant that they can stop participating at any time. Some (but not all) studies will offer money or some other incentive to participate.
There are several reasons why people choose to participate in research – the financial incentive, curiosity about research, and the desire to help others. Since the research participant does not always see the final result(s) of the research, it might not be obvious to them how helpful their participation was. When you review past posts and read future posts, keep in mind that we know what we know about a certain clinical topic because a group of people agreed to participate in clinical research. If you (or a family member) are asked to be in a study, please consider participating. Clinical research is how we learn more about human health and disease.
