Finding Treatments Together: Part I

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. While this definition may sound simple, clinical trial processes are not always so easy to understand. And it’s important to ensure that participants and their loved ones are clear on what to expect throughout the clinical trial process to best determine if a trial is the right choice for them.

That’s why we’re proud to sponsor the latest video series created by the Center for Information and Study on Clinical Research Participation (CISCRP), Finding Treatments Together. In this series, CISCRP provides an overview of clinical research, offers information on how ongoing clinical trials are adapting in the current environment, and shares insight into COVID-19 clinical trial participation and emerging new clinical trial models.

The first video in the series, “General Clinical Research Overview,” provides a helpful outline of the clinical research process and what motivates people to participate.

Therapies are developed through clinical trials

Therapies and their clinical trials all start with a question that doctors and researchers want to answer. To do this, researchers prepare a development plan based on early lab studies, submit a request to regulatory agencies, and then seek volunteers once the request is approved and they’re ready to initiate the study.

Phases of clinical trials

There are four phases of clinical trials, and altogether, the process can take as long as eight years.

• Phase 1: A new therapy is given to a small group of participants to check the safety of the treatment, find the right dose, and track any medical problems.
• Phase 2: Researchers check the therapy’s safety and how it works in participants with a specific disease or condition.
• Phase 3: They then check how it works with a larger group of people with that specific disease or condition.
• Phase 4: Researchers look at how the therapy works in the real world and examine its long-term effects.

Top motivators for clinical trial participation

People volunteer in clinical trials for a variety of reasons. As we found in CISCRP’s 2019 Perceptions and Insight Study, the most common perceived benefit of participating in clinical research is that it may help advance science and treatment options. Other top motivations to participate are to:

• Help others with the same disease
• Gain access to new investigational drugs
• Receive compensation for time and commitment

Informed consent provides an overview of the trial

The informed consent process sets expectations for the study participant and study staff and warns participants of any potential risks and benefits. All study volunteers are required to sign an informed consent form, but this form is not a contract, so they can stop participation at any time. If you’d like to learn more about informed consent, we encourage you to read our overview here.

Clinical trials are made up of multiple components

Participation in a clinical trial has three parts.

• First is the screening period, where the study staff assesses whether the volunteer meets the study entry requirements. These requirements cover details each participant must have, such as the disease being studied, and restrictions, such as medications that a participant cannot have taken in the past.
• Next is the treatment period, where the participant receives the study therapy or vaccine and the study staff monitors their health and safety.
• Last is the follow-up period, where volunteers no longer receive the therapy, but their health continues to be closely monitored. This helps researchers learn more about long-term benefits and issues.

Educational and advocacy resources

There are various resources to help make clinical trials work for you and your family. There are many groups that are underrepresented in clinical trials right now, and it’s important to have a diverse group of participants to ensure that the research is able to find valid, successful potential care options. Read more about Lilly’s commitment to clinical trial diversity here.

You can get involved by:

• Asking your doctor or patient advocacy group how you can help design clinical trials.
• Joining a community advisory board or a biosafety committee at an IRB.
• Learning more about study participation opportunities online or at local hospitals and community health centers.

The importance of clear communication

Ask questions before you participate. During the informed consent process, you can and should ask the research team about the study visit schedule, required procedures, how the results of the trials will be shared, and how you may be affected by participation.

Technology is impacting clinical trials

Clinical trials are becoming more accessible to participants. One way they are doing so is by using technology such as text message reminders, smartphone apps, transportation services to and from clinics, and alternative models to reduce burden for volunteers.

Finding the right fit

The big question is how to find the study that is the best fit for you. There are many types of clinical research. Some are observational and don’t require taking medication. It’s important to have a conversation with your care provider first to determine if the study you are considering is the right next step. Additionally, you can look for online resources that are devoted to connecting people to clinical trials, such as ClinicalTrials.gov, CISCRP’s search tool, and our own website, to name a few.

Watch the full video for helpful visuals, great resources, and questions to consider: