The courage of very ordinary people is all that stands between us and the dark.
—Pam Brown, Australian poet
All life-saving medical advances depend not just on the researchers who develop them and the physicians who administer them. They also depend on ordinary people who play a critical role by their involvement in clinical trials in bridging the gap from today’s medical research to tomorrow’s medical practice.
At Pitt, hundreds of researchers and clinicians are engaged in clinical studies designed to provide more pieces of the puzzle in advancing the prevention or treatment of heart disease, diabetes, cancer, and other debilitating conditions.
What does this mean for you—and your family, friends, coworkers, and the community at large? How can you—and all of them—benefit from this vast body of research being done here and at other medical research centers around the country?
Through CTSI’s Community PARTners Program, community members can become directly involved with multidisciplinary health professionals and biomedical researchers in advancing clinical and translational research as an avenue to better health care. More specifically, Community PARTners encourages and facilitates enrollment in clinical research studies.
To guide you through what many people might say is an unfamiliar and seemingly complex subject, here are links to some fundamental information.
- What is clinical research?
- Why is clinical research important?
- What is the role of Community PARTners in promoting clinical research?
- Can you give me an example of clinical research that has resulted in better health care?
- What can I expect if I agree to participate in clinical research?
- What do I need to know before volunteering for a clinical trial?
- What kinds of questions should I ask before participating in clinical research?
- Are there advocates for research participants at Pitt?
- How do I go about finding a clinical trial?
- What is the Research Participant Registry?
- How can I sign up for the Research Participant Registry?
- Where can I get more information about clinical research?
What is Clinical Research?
Clinical research is a medical study that tests the safety and effectiveness of new or updated treatments, medications, or medical devices with the participation of volunteer human subjects as part of a carefully regulated protocol, governed by strict rules of conduct, prior to making these treatments available for widespread clinical use. (The Office of Clinical Research, Health Sciences maintains a broad listing of other research terms and definitions.)
Why is Clinical Research Important?
Without this critical step in the process of moving from laboratory research to patient treatment and eventually to public health practice, doctors and scientists would have the knowledge that comes from research, but no one would benefit from it. Researchers working on new treatments for disease would have no way of knowing whether the treatments are effective. The more clinical research that is done, the more treatments and drugs can be developed to help people live healthier lives.
What is the Role of Community PARTners in Promoting Clinical Research?
Fewer than 4 percent of people with cancer generally participate in cancer-related clinical studies—and that’s just one example. Whether participation is so limited because people distrust clinical research or simply because they have no interest in it, many of them don’t know what its benefits or risks are; consequently, they have no idea how clinical research can affect their health care and that of their family members, friends, and neighbors. Through a wide range of initiatives, CTSI’s Community PARTners is working to raise awareness about the benefits of clinical research in hopes of generating a vested interest in it that people will realize can translate into better health care.
Can You Give Me an Example of Clinical Research that Has Resulted in Better Health Care?
A perfect example of clinical research is the Salk polio vaccine, which was developed here at the University of Pittsburgh and involved the participation of thousands of participants, including school children around the country who were immunized with the test vaccine, in the clinical trial process.
What Can I Expect if I Agree to Participate in Clinical Research?
The experience of participating in a clinical trial can vary widely depending on the nature of the study. In some cases, it might be as simple as undergoing a physical exam and answering a series of questions; in other cases, administration of new pharmaceutical products or treatment regimens could be involved. Follow-ups over a period of time are typical. People who volunteer for a clinical study often receive health screenings and medical attention at no cost to them. While clinical research participants may receive and benefit from medical treatments that aren’t yet widely available—a cancer patient in a clinical trial of a new chemotherapeutic agent, for instance—it’s important to realize that such results are not guaranteed.
What Do I Need to Know before Volunteering for a Clinical Trial?
Most importantly, anyone interested in getting involved with clinical research needs to be well informed about any studies for which they volunteer. It’s important to ask questions and to seek clarification or more explanation about anything you don’t understand. The researcher conducting the study or a member of the research team should provide full information about the nature of the study. In addition, participants must provide informed consent—a signed consent form that explains the nature of the study, including its possible benefits and risks—before they can take part in the research. While risks may be involved in clinical research, extensive protections and safeguards are built into the clinical research process, including oversight by Pitt’s Institutional Review Board, a panel of scientists, physicians, and others whose role is to ensure that any research involving human subjects is as safe as possible.
What Kinds of Questions Should I Ask before Participating in Clinical Research?
Questions will vary with the individual and the particular study, but here are some basic things you might want to know:
- What’s the purpose of the study?
- What am I being asked to do as part of the study?
- Who is performing the research?
- Where is the study being done?
- What kinds of tests, treatments, or procedures does the study entail?
- How long will the study last?
- What is the time commitment on my part, both at the outset and long term?
- Are there risks or side effects involved? If so, what are they?
- How will my safety be monitored and protected?
- How could this study possibly benefit me or others?
- What are the results of any previous related studies?
- Who is paying for the study?
- Will my participation in the study cost me anything?
- If so, will my insurance provider cover any or all of the expenses?
- Will I be compensated for my participation?
- What can I do if I become dissatisfied with the experience, either during or after the study?
- If I agree to participate, can I stop before the study is over?
- If I experience a health benefit from treatment during the study, is there any way to continue it once the trial is finished?
- What happens if I am harmed by the study?
- How will my privacy be protected?
- Who do I contact if I have other questions?
Are There Advocates for Research Participants at Pitt?
Yes, research participants can contact either the human subject protection advocate at the University’s Institutional Review Board (1-866-212-2688) or Pitt’s research participant advocate (412-383-5808). Either one of these advocates can address questions about your rights as a research study participant.
How Do I Go about Finding a Clinical Trial?
The Study Finder maintained by the Office of Clinical Research, Health Sciences allows users to search quickly and easily for clinical studies for which they might be eligible. Some studies need participants with particular health conditions; other studies need healthy subjects. People of all ages and ethnic groups are needed as study participants. Other resources for finding clinical trials include the National Institutes of Health, Center Watch, Search Clinical Trials and the National Cancer Institute.
What Is the Research Participant Registry?
The Research Participant Registry is a database of individuals who are willing to participate in clinical research studies at the University of Pittsburgh and/or UPMC plus an ongoing list of current studies being conducted by our researchers. The goals of the registry are to provide community members and patients in the UPMC network opportunities to receive educational materials about clinical research and to get their permission to be contacted for study recruitment. In doing so, CTSI hopes to create research-informed community members and patients who develop an understanding of the potential benefits of participating in clinical research studies as a way to achieve better health care for themselves and others.
How Can I Sign Up for the Research Participant Registry?
It’s easy. Just fill out and submit the Research Participant Registry form, and you will be contacted about your possible participation in a clinical study.
Where Can I Get More Information about Clinical Research?
The Office of Clinical Research,
Health Sciences at the University of Pittsburgh provides a wide range of online
information
resources on topics designed to educate research participants and the public about clinical
studies. The categories include general information, cancer trials, children, costs, drugs and
devices, gene therapy research, HIV/AIDS, mental health research, minorities, older adults, serious
or life-threatening illnesses, and women’s issues. On the same Web site, you can find answers
to frequently
asked questions about clinical research. Another local resource is a UPMC brochure titled
“Clinical Research:
Volunteering in Clinical Research Studies at the University of Pittsburgh.”
If you’d rather speak to someone in person about clinical research at the University of
Pittsburgh or UPMC, here are some key phone numbers.
- For general information:
Office of Clinical Research, Health Sciences – 412-648-2332
Clinical and Translational Science Institute – 412-864-3487
- For information about personal rights as a research participant:
Human Subject Protection Advocate of the University of Pittsburgh IRB – 1-866-212-2688
Research Participant Advocate – 412-383-5808
More information about clinical research participation is also available through the National Institutes of Health Clinical Center.
