Explaining Research

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What is translational research?

It’s not research about language translation between, for example, English and Spanish! Rather, “translation” refers to the process of getting to new medical treatments and devices. Scientists have ideas about something they would like to test out, and they seek resources for experiments. Most experiments start in the laboratory and this is called “basic research”. Many new treatments are tested in animals before any humans are permitted to try them out. And even then, many types of experiments need to be done before a new medical device or treatment is approved for regular use by your doctor and other clinicians. The phrase “translational research” is all the steps in this process.

Even after a new medical treatment is available for use, translational research is not always complete because researchers try to get feedback from patients and their doctors and try to make the treatment even better. “Selling the new idea” to patients, health insurance companies, public health departments, and doctors is often also part of “translational research.

For translational research to be successful, communication must be bi-directional. In other words, many different people have to talk—and listen—to each other: basic researchers and clinical researchers; clinical researchers and human volunteers; patients and their doctors in their communities; and community doctors and clinical researchers.

What does the CTRI have to do with translational research?

The main goal of the CTRI is to make our research discoveries more rapid, effective, and useful to the general public. We improve health care by providing scientists and community leaders with resources and information, and we encourage interactions between all those different people mentioned above. We also offer many educational programs for scientists, students, and the public. Those are some of the ways we try to help speed up the translation of great ideas into great therapies.

What is clinical research?

Clinical research is the step in the translational research pathway where humans first get involved. All experiments involving humans are called either “clinical trials” or “clinical studies”.  This clinical research process is an improvement over the old days, when researchers depended on accidental discoveries. Nowadays, they thoroughly plan and carefully conduct research. At the same time, medical treatment has progressed from the simple relief of symptoms to understanding how diseases do what they do. In some cases, research can lead to the actual curing of diseases.

How is research made safe?

There are many safeguards in place to help keep research safe, including eligibility criteria and review by an Institutional Review Board (IRB). Watch the video to learn more.

VideoHow is research made safe (Video)

If research involves a drug, device, or procedure, the FDA must first approve the research before testing can be done in humans.

If a drug is found to work in humans (i.e., it is “effective”) without serious side effects (i.e., it is “safe”), it still has to go through more approval by the FDA before it finally becomes available for doctors and patients to use.

Who is involved in clinical research?

It takes many people for success!

  • The SPONSOR of the clinical trial provides the primary funding and may also have a role in its design and conduct. Often, the sponsor is a federal agency such as the National Institutes of Health (NIH) or a pharmaceutical company.
  • A key person in the research study is the PRINCIPAL INVESTIGATOR, commonly called the "PI." The PI conducts the clinical research, and may have designed it or may have been chosen to conduct it by a sponsor.
  • At each research institution is a group of persons known as the INSTITUTIONAL REVIEW BOARD (IRB). The IRB consists of doctors, scientists, and non-medical persons from the community, who must review and approve all clinical research done at that institution. No clinical research can be started without IRB approval. At UCSD, the IRB is also called the HUMAN RESEARCH PROTECTION PROGRAM (HRPP).
  • The most important person of all in every clinical trial is the volunteer PARTICIPANT, sometimes called the research subject. Without these volunteers no clinical research can be done!

How are studies designed?

Clinical research studies are designed to be informative and safe. The following videos explain some of the common elements, including control groups and randomization, seen in research studies.

VideoWhat is a control group? (Video) (2 min)

VideoWhat is random assignment? (Video) (3 min)

Who can become a participant in clinical research?

  • All clinical trials have guidelines that explain who can participate. The guidelines are based on factors such as age, medical history, illness, and current medication. These factors are used to identify appropriate people to participate, and keep them safe.

Video Who can participate in research? (Video) (2 min)

  • Clinical trials also often need people who are free from disease or illness to serve as "healthy subjects" or CONTROLS—people who are compared to the research participants who actually have the disease or illness that is being studied.
  • For ways to volunteer for a research study, please click here.

What is informed consent? It has two parts:

  • A clinical researcher or his/her colleague explains the study to you, and answers all your questions. This is the “informed” part.
  • If all of the conditions that they explain to you are acceptable to you, and if you agree to participate in the study, then you sign the informed consent form. This is the “consent” part.

What should I do before joining a clinical trial?

Be sure that you have answers to the following questions before giving consent:

  • Who is the Principal Investigator? or Who is the sponsor?
  • Are there any personal benefits from this trial?
  • What are the risks?
  • What tests and procedures will be performed as part of this study?
  • Will I be paid for participating in this clinical trial? How much?
  • What medications or foods do I have to avoid? What activities do I have to avoid?
  • What medications or foods do I have to take? What activities do I have to perform?
  • What alternative treatments are available outside of this clinical trial?

Also, make sure that:

  • The language in the informed consent document is clear to you
  • You can ask any questions you want
  • The consent form that you read and sign was approved by the IRB. There should be a dated stamp on the document certifying that it was approved by the IRB
  • The consent form says that you can leave the trial at any time you wish. You will be able to get medical care even if you leave the clinical trial
  • The consent form says that the PI can discontinue you from the trial at any time
  • The consent form says that you keep all your legal rights even if you sign the consent
  • You are given a copy of the informed consent document to keep, and a copy of the Research Subject's Bill of Rights

Why do people get involved and decide to participate?

There are many reasons that people decide to get involved in research. Watch the following videos to see a few stories.

NIH Clinical Research Trials and You - Personal Stories

Video“Seniors Making a Difference” (10 minute video) English

Video“¿Por qué debemos participar en studios de investigación? (10 minutos) (Español)

             (“Why should we participate in Research Studies?”) (10 min) Spanish

How can I learn more?

You can view easy-to-understand videos about clinical research on our YouTube channel. Plus you can look up unfamiliar words in our Clinical Research Glossary. You can always contact us directly: Give us a call at (858) 657-5139 or send an email to ctri-community@ucsd.edu and we may be able to help.