What is clinical research?
Clinical research is research that directly or indirectly involves humans as subjects and can include any of the following:
Direct interaction or intervention between a person or group of people and an researcher such as:
- Medical history from interviews or reviews of medical charts;
- Physical examinations;
- Blood and urine tests;
- Collection of tissue specimens;
- x-Ray, MRI or other imaging study;
- Interviews, questionnaires and surveys.
- Interventions such as a drug, vaccine, diet, psychological counseling or medical device.
Indirect interactions between a person or group of people and a researcher, such as a review of medical records.
What are some of the types of clinical research?
Clinical research includes a wide range of research including:
- Investigation into the mechanisms of human disease
- Studies of the genetics of disease
- Studies of therapies or interventions for disease. These are known as clinical trials
- Studies to develop new technology such as diagnostic tests and devices
- Epidemiological and behavioral studies
- These studies examine the spread of disease, factors that can affect health, and how people make health-related decisions.
- Outcomes and health services research
- These studies seek to identify the most effective and most efficient interventions, treatments, and services.
What are the steps in a clinical research study?
The investigators must first develop a research idea. The best ideas are often based on a problem experienced by the researcher's patients. The researcher usually reads medical journal articles and talks with colleagues in order to learn what others have already done and to improve their ideas.
Before a researcher can begin a study, they need to secure funding to pay for study personnel, statisticians, lab tests, supplies and other costs. A study that only involves a questionnaire could be very inexpensive while a study to test a new drug therapy could be quite expensive. Some research, particularly studies of new drugs, is funded by pharmaceutical companies but most of the research that takes place at CHOP is funded by the National Institutes of Health, large foundations or by CHOP itself.
Once the researcher has secured funding to pay for the costs of the study, they need to develop a formal protocol that outlines their plan in detail. The research protocol is the recipe for the study. It outlines the objectives, describes which individuals will be allow to take part, lists all of the procedures and specifies the plans for analyzing the data. The protocol also describes all of the steps that will be taken to protect the individual participants.
Even with grant support and a protocol, the study still needs one more approval from the IRB (institutional review board) which is the hospital's research ethics committee. The members of the IRB have expertise in scientific areas, the conduct of research, research ethics, federal and state laws that govern research and at CHOP, the issues of importance to understanding children and their development.
The IRB is made up of individuals who are independent of the research study. Its job is to protect the rights and welfare of study participants. Its members include:
- doctors and other scientists
- nurses, pharmacists and other care providers
- lay people without scientific training
- people from the community who are not employed at CHOP
The IRB system ensures that an independent group has examined each study and approved it before the research begins. The IRB is also responsible for approving the study consent forms. The IRB makes sure that the consent form accurately describes the purpose of the study, the procedures, the risks and benefits and the protections of the participants confidential information.
Once the IRB has approved the research protocol and consent forms, the investigator can finally start to enroll participants and conduct the research. Some studies only involve a short questionnaire and then are over; others involve experimental treatments that last for years. Regardless of how long the study lasts, the investigator has to follow the plan outlined in the protocol and has to monitor the participants to ensure that the study is safe for them. At least once a year, the investigator has to send a report to the IRB.
When the study is completed, the investigator gathers all of the data collected and begins to analyze the results. For more complex studies, it can take years to finish the analysis and many research papers might result. The process for other studies could be quite quick. In addition to publishing results in medical journals, the results of studies can be presented in lectures and at scientific meetings.