Are you interested in volunteering for a research study or clinical trial?
There are many reasons why you may be interested in being a part of a research study or clinical trial. You may be looking for access to the newest medical treatments, investigational drugs or medical devices or you may be interested in helping other people by testing out new approaches to disease management. Whatever your motivation, there are certain things that you need to know about before the decision is made to volunteer.
Clinical trials differ from standard medical treatment that you would receive from your healthcare provider in several important ways. The following table summarizes the key differences:
Clinical Research vs Medical Treatment
|Clinical Research||Medical Treatment|
|Intent||Answers specific questions through research involving numerous research volunteers.||Addresses the needs of individual patients.|
|Intended Benefit||Generally designed and intended to benefit future patients.||Intended to benefit the individual patient.|
|Funding||Paid for by drug developers and Government agencies.||Funded by individual patients and their health plans.|
|Timeframe||Depends on research protocols.||Requires real-time decisions.|
|Consent||Requires written informed consent.||May or may not require informed consent.|
|Assessment||Involves periodic and systematic assessment of patient data.||Based on as-needed patient assessment.|
|Protections||Protected by government agencies, institutional review boards, professional standards, informed consent, and legal standards.||Guided by state boards of medical practice, professional standards, peer review, informed consent, and legal standards.|
|Certainty||Tests products and procedures of unproven benefit to the patient.||Uses products and procedures accepted by the medical community as safe and effective.|
|Access to Information||Considered confidential intellectual property.||Available to the general public through product labeling.|
|Release of Findings||Published in medical journals, after clinical research ends.||Individual medical records are not released to the general public.|
What is a Clinical Trial or Clinical Research?
A clinical trial or clinical research is a study where people volunteer to test new drugs, medical devices or procedures. This is the way that we find out if a new treatment works and is safe for people. These kinds of studies are needed to develop new medicines and treatments for osteoporosis or other conditions. If you meet the requirements for one, you will get to decide if you want to take part in it.
Clinical research is research that directly involves a particular person or group of people, or that examines humans in other ways, such as their behavior, or uses samples of their tissue. Clinical research in osteoporosis can be broadly divided into two areas: testing new therapies, and expanding our understanding of different aspects of osteoporosis.
A clinical trial is one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials, participants can play a more active role in their own health care. Most importantly, participating in clinical trials helps others by contributing to medical research.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to
- Make sure that the study is ethical
- Protect the rights and welfare of the participants
- Make sure that the risks are reasonable when compared to the potential benefits
In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.
One thing to keep in mind is that there is always uncertainty when you are considering participating in a clinical trial. The researchers and doctors who conduct the study do not know, before you start, how things will turn out or else they would not need to do the study.
You may not hear much about clinical trials until your healthcare provider mentions it as a possibility for you. While medical breakthroughs, discovered through the clinical trials process, may make the news, usually we don’t hear about the clinical trial itself unless something goes wrong and someone is harmed. Clinical trials are carefully designed and reviewed to minimize harm and ensure safety for patients, but very rarely, people have been injured while taking part in a study. These study outcomes are very important, even if they are tragic, as this information is used to identify problems which can be resolved so they don’t happen again. Clinical trials are subject to numerous laws, procedures and requirements designed to protect the rights and the health of human volunteers.
There are many osteoporosis clinical trials in progress. Patient participation in these trials is essential to learning about the possible causes of osteoporosis and fractures, testing promising new, safe and effective therapies, and ultimately, finding a cure for osteoporosis. Thousands of people take part in clinical trials each year and are helped because they made the decision to participate and millions of others benefit from the participation of volunteers in these studies. This is information you won’t likely see in the news.
Taking part in a clinical trial is not an easy decision to make and there is no right or wrong choice. The decision is a very personal one and depends on many factors, including the benefits and risks of the study and what you hope to achieve by taking part. It also depends on your own values, preferences, and priorities.
Knowing all you can about clinical trials in general – as well as the ones you’re thinking about taking part in – can help you feel better about your decision. If you do decide to take part, knowing what to look for and what to expect ahead of time can be helpful, too.
Where can I find information about clinical trials?
One good way to find out if there are any clinical trials that might help you is to ask your doctor. Other sources of information include:
Clinicaltrials.gov. Search a database of federally and privately supported studies available through clinicaltrials.gov. Learn about the purpose of each trial, who can participate, locations, and who to contact for more information.
CISCRP: The Center for Information and Study on Clinical Research Participation (CISCRP) is a nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process.
National Institutes of Health: The National Institutes of Health (NIH) is a federal organization dedicated to clinical research. This website provides basic and advanced information about all aspects of medical research with answers to frequently asked questions.
BHOF is sometimes asked to distribute information about clinical trials, clinical research and surveys to our patients. To protect your privacy, we will not give out your personal information to any third party. If you are interested in getting information from BHOF about these research opportunities, please click here to sign up. When opportunities arise, BHOF staff will notify you and you can ask for more information.