Clinical Research: Studies with People
From Surveys to Treatments
When it comes to health and disease, many factors can play a role. Inheritance (genes), lifestyle, support systems, environment, infection, accidents, stress and normal aging can all contribute. Many times, several of these factors affect our health. Someone with a family history of heart disease, for example, can reduce risk by eating healthy foods and getting regular exercise. In another example, a person can “catch” strep bacteria from another person with that infection and never develop symptoms of a sore throat. Medical researchers have developed a safe and effective process to understand how all these factors affect our health. First, basic science research uncovers new knowledge about conditions related to health and disease. Next, these discoveries are tested through research studies where people take part. This clinical research is a vital part of the process so that the best medical science can be applied in real life situations to prevent, treat and cure disease.
There are many methods of clinical research, each one giving a different kind of information to improve health and medical care. In some studies, people answer questions with a paper and pencil survey. In others, a person with a medical condition like diabetes might be part of a group getting a new drug treatment when it is still in a testing phase. Several clinical research methods are described below.
- Surveys, Interviews and Focus Groups
- Medical Records
- Observation Studies
- Clinical Trials
- Community-Based Participatory Research
Surveys, Interviews and Focus Groups
Survey research is an important way for researchers to learn more about a health question. In this kind of research, volunteers provide information directly which can include things related to their experience, knowledge, attitudes, family history, health history, and/or health routines. For example, a survey might include questions about what you eat, how much exercise you get, how much you sleep or how your doctor can help you to better care for your health.
Some surveys are done individually where you fill out the information yourself. These surveys can be done with paper and pencil or on a computer and can be done at home, in a group-setting (e.g. a classroom or meeting), or at your doctor’s office. Sometimes, instead of filling out the information, surveys are done by an interviewer. Rather than writing answers yourself the researchers write down and/ or record your responses. In addition to structured questions, interviews provide more opportunity for interaction between the volunteer and interviewer than a paper and pencil or computer survey does.
Focus groups are a kind of group interview where the researcher asks questions from the group and gathers responses. In a focus group, you will hear the answers from everyone creating a kind of group discussion.
Information from survey, interview and focus group research can add to health knowledge for better patient care, improved health systems, and better ways to share health messages such as public service announcements for teens on smoking prevention.
Your doctor keeps health records to keep track of your health and to be sure that you are getting the best medical care. Through study of records from a number of people, researchers can learn important things to prevent and treat disease. For example, a study could look at records of people taking two different kinds of medicine for high blood pressure to see whether one group or the other had more side effects. Another example might be to see if there was a difference in smoking rates for patients who had more conversations with their doctor about ways to stop. Now that more and more records are becoming computerized, records can be used more effectively to tell us about health.
The important thing to know is that there are very specific rules in place about using medical records for research that are supervised by the institutional review board (IRB) at the researcher’s organization. The main rule is simple: if there is any way that a study can link information in the study back to a particular patient, the person whose record is being looked at must give permission. The “informed consent” for the study will tell you specifically what information in your medical record will be included, how your information will be used, and what protections are in place to keep your information secure.
One of the most important tools a doctor has to screen for and diagnose disease is samples from the patient including things like blood, urine and biopsies (such as skin or colon polyp). For an individual person, analysis of these samples can determine if there are conditions such as diabetes, high cholesterol, gene defect, cancer or pre-cancer. This is very important for guiding the best care and treatment. Samples from a number of people can also be used as a very important research tool to learn about conditions and give guidance for the future care of patients. Many medical breakthroughs in cancer treatment, for example, come from researchers looking at blood and tumor samples in the laboratory. Researchers call these ‘biosamples’ and use them to develop treatments for cancer.
Just like the situation described above, if a researcher wants to do research with medical samples, there are very specific guidelines that must be followed, and permission from the person must be obtained if there is any possible linkage to an individual patient.
Have you ever watched something and learned from it? Observational studies involve looking at and learning about what happens naturally in a life process. The researcher observes and records information and then draws conclusions. Observation studies can be short-term or long-term and can look at many kinds of health issues. One example would be observing interactions between parents and children and keeping track of time spent using digital devices, compared to direct interaction, e.g. talking together, homework activities, mealtime conversation. A more long-term example would be a study that looked at heart disease in women over a period of years. Information would be collected on regular activities, medical care and heart conditions, but there would be no changes of approach or specific treatments as part of the study. Conclusions in each example would come from the observed information and measurements. If researchers find factors that might prevent or lead to disease, those factors can be tested in a clinical trial.
A clinical trial tests a new approach to medical care such as a drug, medical device, surgery or prevention approach. The term clinical trial emphasizes that the research is in a testing or trial stage before it can be approved for regular medical care. These studies are an essential step to be sure that a new approach is safe and effective for general use. In the case of a new drug treatment, a clinical trial would answer questions such as:
- Does the drug improve the medical condition?
- Is it safe?
- Does it have side effects?
- Does it have long-term complications?
- How much should people take?
- Is it any better than medicines that are already on the market?
- What are the possible health risks compared to health benefits?
An example would be a breast cancer drug trial to learn whether a new drug is more effective than an existing drug in keeping breast cancer from coming back in women who have been treated previously. For more information see What is a Clinical Trial?.
Community-Based Participatory Research
This is an exciting area of research that continues to grow as a way to learn more about health. In this kind of research, people take part as community researchers, working side by side with medical researchers to identify research questions, design studies and conduct the research. To learn more about this research and how to get involved see Community-Based Participatory Research and Prevention Research Centers.
Ready to Participate in Research?
The following NetWellness articles will help you learn more about how you can take part in research.
- Being a Partner in Research: Ways to Take Part
- Behavior and Health: Research that Makes the Link
- Join the Research Team
- Research Volunteers: Medical Heroes
For more information:
Go to the Research Center health topic.