Broadly speaking, research can be defined as the search for knowledge. There are two kinds of biomedical research:
While the purpose of each research project may vary, all projects follow the same basic steps; it is the purpose of the projects that vary. Another common denominator is that each project is carefully controlled for quality and safety.
The Lang Research Center encourages our physicians to study the pressing medical questions in their practice and to seek the answers to those questions through a research study. We support them in that effort by fostering a collaborative research environment and by assisting investigators in the following eight major steps of the clinical research process.
The first task is to state the focus of the proposed study precisely. The investigator needs to be clear about what knowledge or data currently exists concerning the topic and what specific question the study will answer.
Funding can come from a number of sources. Within the hospital, there may be funds set aside for research projects. Sources outside the hospital include government, industry, foundations and individuals.
A protocol is a detailed plan that describes the purpose of a study and how, exactly, it will be carried out. There are several different methods for conducting research, and the method chosen will depend on what the investigator is trying to find out. Study types can include trials for treatment, prevention, diagnosis, screening, and/or quality of life.
The protocol or study plan will include such details as the reason for the study, the number of participants required and their eligibility and exclusion criteria, what interventions or therapies will be carried out, the specific steps to be taken and by whom, what information will be gathered, a timetable, and other guidelines and information. The protocol will also specify how the study will comply with professional guidelines and with the extensive regulations and laws of federal, state and local authorities for the protection of human research subjects.
All members of the study team must follow the procedures of the protocol exactly. Before the study begins the team is carefully trained in interview skills, understanding the study goals, how to administer informed consent, how to document the data collected, and other fundamentals. The study team can comprise a broad range of personnel including physicians, nurses, data managers, data entry specialists, pharmacists, laboratory support staff, statisticians, patient advocates and others.
The protocol is submitted along with attachments through the Institutional Review Board (IRB) office.
The study team uses a variety of methods to notify people about the study, which include speaking to community groups and alerting health care providers and organizations. They also post notices on clinicaltrials.gov and other websites as well as in newspapers or journals.
When someone expresses an interest in being part of a study, that person is carefully screened for eligibility, and if eligible, asked to sign an informed consent form. This process involves a discussion of the potential risks and benefits of participating in research and the responsibilities of the study staff. If the candidate decides to proceed, he or she is then officially enrolled as a study participant.
The conduct of the study follows the procedures outlined in the protocol. Members of the team provide the patient with a detailed schedule on when data will be collected as well as ongoing education about the process. All data collected are entered into the study’s data collection system, according to the schedule and procedures described in the protocol. Studies are continuously monitored to ensure that the participants are being protected and that the integrity of the data is being maintained.
At the end of the study, the data collected are reviewed for completeness and then archived, along with any related papers and documents. The archive is locked, so no one can change the data, and access is restricted.
The data are analyzed according to the statistical and analytic plan outlined in the protocol. The first analysis is intended to produce conclusions about the study: What was the answer to the question? A second exploratory analysis employing a different approach may be used to generate new ideas for future studies.
Communicating the results of a study is what validates the research process. The answer to a question from a clinical research project may benefit many people, including:
Not every study addresses the biggest question or produces the most dramatic answer, but every study has the potential to make a worthwhile contribution to the advancement of human health and well-being.