Clinical trials involve many different people and institutions coming together to better understand disease, biology and the impact of potential medicines. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and improve public health. But they are more than a process – it takes a dynamic and collaborative R&D ecosystem to conduct efficient and effective clinical trials, including biopharmaceutical companies, government agencies, nonprofit foundations, academic institutions, hospitals, community-based medical practices, physicians, research nurses and of course patients.
Over the coming weeks and months, this blog series will highlight different aspects of the clinical trials process. We’ll hear from the people and organizations that are on the front lines of bringing essential medicines to the patients that need them and how the utilization of clinical trials can create better health outcomes.
For our first blog post in this series, I recently spoke with Danielle Lavieri, communications and outreach coordinator, for the Center for Information & Study on Clinical Research Participation (CISCRP) about their work to increase understanding about clinical trials.
What are clinical trials?
Clinical trials can seem daunting to anyone who doesn’t understand the clinical research process; however, they are the most effective way to discover and develop new treatments that may help many people with a particular disease or condition. At the Center for Information & Study on Clinical Research Participation (CISCRP), we strive to educate both patients and the public about clinical research and empower those communities to make informed decisions about whether participating in a clinical trial is right for them.
Clinical trials are research studies involving human volunteers that aim to answer specific health questions. Although the use of the phrase “human volunteers” may sound a bit scary, rest assured that all studies are closely and carefully monitored by Institutional Review Boards (IRBs) in order to ensure the highest level of safety and comfort for all trial participants. To ensure additional safety, informed consent forms are given to all prospective volunteers, laying out information about the study with details about the process and agenda of the study visits. In fact, carefully conducted clinical trials are the safest and fastest way to find effective treatments and new ways to improve health.
Understanding who participates and why they choose to volunteer is another important part of deciding whether participation is right for you. Each person’s decision to participate is different, and it is a very personal one because of all the factors involved. For example, a patient may choose to participate in order to try a different medical treatment from the standard treatment they are currently receiving. A mother might choose to participate as a healthy volunteer because her children or grandchildren suffer from a particular condition, and she wants to contribute to the greater efforts of finding a cure. Someone else might decide to participate because there are no available treatments and the trial is a way to gain access to a new potentially life-saving medicine.
If you’re considering participating in a trial, it's most important to inform yourself ahead of time about the research process and implications involved so that you know what to expect. The experience may be difficult at times, but it’s helpful to remember not only how it could potentially benefit you, but how it also benefits others with the same illness and contributes to medical knowledge.
What are the questions that people should consider when speaking to their doctor or the study coordinator?
A good place to start is by taking note of any questions you may have about a particular study or clinical research in general. You can ask the study coordinator or your doctor.
Here are some questions to consider:
- What is the main purpose of the study?
- Does the study involve a placebo or a treatment that is currently on the market?
- How long will the study last, and what will I be asked to do as a participant?
- What has been learned about the study treatment and are any of the results published?
- What are the credentials and research experience of the physician and study staff?
- If the treatment works for me, can I keep using it after the study?
These, as well as other questions can be found in CISCRP’s Education Before Participation brochure series, available on the CISCRP website.
While it may seem like there’s a lot to learn about the clinical research process, reading this post has already put you ahead of the game. As the primary stakeholder in your own health, knowledge is the best way to feel empowered. Ask your doctor about the options for medical care and about available alternatives, should you not experience success with the standard treatment.
For additional information about clinical research, visit ciscrp.org or call 1-800-MED-HERO (633-4376) to talk to a member of our knowledgeable staff.
Danielle Lavieri is the Communications and Outreach Coordinator for the Center for Information and Study on Clinical Research Participation (CISCRP) in Boston, MA. Danielle works on a variety of projects in this role, including managing communications for AWARE For All, writing for CISCRP's many public-facing platforms, and engaging both professionals and the public in meaningful conversations about clinical research.
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today's challenges and opportunities. The Catalyst welcomes guest contributors including patients, stakeholders, innovators and others to share their perspectives and point of view. Over the coming weeks and months, Clinical Trials Q&A, will highlight different aspects of the clinical trials process from the people and organizations on the front lines of bringing essential medicines to the patients that need them. Like our Conversations series, views represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.
Jocelyn Ulrich Jocelyn Ulrich, MPH, is Deputy Vice President, Policy and Research, at the Pharmaceutical Research and Manufacturers of America (PhRMA). At PhRMA, she is responsible for developing legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, the R&D process, the value of innovation, and other issue areas impacting the environment for innovation. In addition to her experience at PhRMA she has over 15 years of experience in the pharmaceutical industry at Pfizer, Human Genome Sciences, and EMD Serono in roles in clinical research management, investigator-initiated and collaborative research, and global policy and corporate affairs. Jocelyn holds an MPH in global health policy and management from New York University.
Topics: Clinical Trials