What is clinical research?
Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose, and treat illness. A clinical trial is a type of clinical research.
What is a clinical trial?
A clinical trial is a research study designed to understand the safety and effectiveness of a drug, vaccine, or device in order to find new or improved ways to treat, prevent, or detect different health conditions. Participants in a clinical trial may be patients with a specific health condition or healthy individuals, depending on the nature of the research study. Clinical trials are carefully designed, reviewed and completed, and need to be approved by the regulators and ethics committees before they can start. People of all ages can take part in clinical trials, including children when appropriate.
What are some of the reasons people decide to participate in a clinical trial?
Clinical trials are critical to find new, safer, or more effective drugs, vaccines, and devices to treat, prevent, or detect various health conditions, including those with no current treatment or prevention. By participating in clinical trials, individuals have the opportunity to get more involved in their own health care, learn about their condition or the condition being studied, and access free, study-related medical care, while making a contribution which helps improve their lives and the lives of others by bringing new drugs, vaccines, or devices to market.
Will participating in a clinical trial cost me anything?
Participants do not have to pay to participate in a clinical trial. All trial related tests, medication, and treatment will be provided to you at no cost. You may also be compensated for your time and effort.
Will I be paid for participating in a clinical trial?
Most trials will compensate you for your time, travel, and any other expenses incurred through the course of the study. Some trials may even offer additional compensation. This information will either be displayed on the study web page, in various study materials, or shared by Lightship’s study team should you qualify for the trial.
Is it safe to take part in a clinical trial?
Safety of participants is our number one priority. Before starting a study, we extensively plan and obtain various approvals from medical regulators and independent ethics committees, who review all available information to assess potential risks and benefits before deciding whether a trial can go ahead. Throughout the study, participants are under close supervision of highly qualified medical professionals who are responsible for the participants’ ongoing safety. Prior to joining the study, any known side effects and alternatives to participation will be discussed with you as part of the informed consent process, as will the study procedures. Any and all of your questions about participation will be answered, as well. If you were to experience any side effects from your participation in the study, those would also be effectively monitored and addressed.
How do I know if a clinical trial is right for me?
Every clinical trial has unique specifications for who is eligible to participate. These criteria are determined by the purpose of each trial, and can include factors such as age, gender, medical history, and the type and stage of your condition.
If you do not qualify for the trial that you are interested in, you may qualify for a different trial studying the same condition. You will have the option of joining Lightship’s patient community to receive updates about other trials that may be of interest to you.
How does Lightship enable me to participate in a study from my home?
Lightship is committed to minimizing the impact of participating in a clinical trial on everyday life; therefore, when possible, we bring the study to you. Depending on the nature of the trial, you may be able to complete some or all study procedures from the comfort of your own home. Lightship’s trained nurses will visit your home to conduct study visits, and/or you may be asked to communicate with the study doctor via a secure video call. Study supplies and medication, where permitted, will be shipped to your home, and our study team will discuss with you how to receive, store, and administer your medication. You will also be offered access to Lightship’s mobile application which will provide you with necessary prompts and reminders, so you know what to do when, whilst ensuring that you feel supported throughout your study journey. The home-based studies encompass the same quality and safety oversight as the clinic-based studies, whilst reducing the time and effort participants spend travelling, and whilst protecting vulnerable patients from potential exposures to COVID-19 and other viruses (e.g., influenza).
What safety measures do you take to protect participants from COVID-19?
At Lightship, we do everything we can to ensure our participants and staff are safe from potential exposures to COVID-19. The nurses who visit you in your home have been vaccinated against Coronavirus. On arrival at your home, nurses will be dressed in appropriate personal protective equipment, including a face mask and gloves as needed. Once all procedures are complete, nurses will disinfect all surfaces used during the study visit and take any waste away with them. If there is anything else we can do to make you feel comfortable during your visit, please let our study team know.
How much time does it take to participate in a clinical trial?
Time commitments vary from trial to trial. When signing up for a trial, Lightship’s study team will be able to answer any questions on what time commitments are involved. This will help you decide whether the trial is right for you. At Lightship, we are committed to minimizing the impact of participating in a clinical trial on personal and work schedules which is why we endeavor to do as many of the study visits in your home as possible.
Can I change my mind about taking part at any point?
Yes. You can leave a clinical trial at any time and for any reason, and you are under no obligation to explain your reason for leaving. If you have any questions or concerns, Lightship’s study team is always available to talk and address any concerns you may have.
What will you do with my data?
We take data protection seriously at Lightship. Your personal information is confidential and is stored securely to protect and respect your identity. Prior to joining a study, we will discuss with you what information will be collected and how it will be processed and protected, so that you are fully aware of what happens to your information.
We will never share your personal information with any company outside of Lightship without prior notification and consent. Once you join a trial at Lightship, you will be assigned a unique participant number to make sure that you cannot be identified from your data. Only appropriate study personnel will be able to match your name to this unique participant number. This number will be shared outside of Lightship when necessary, including with the organization sponsoring the research in order for them to analyze study results.
Can I tell my doctor about my trial, and will my doctor continue to be involved?
Your doctor may recommend a trial that they think is right for you. If you identify a clinical trial yourself, we recommend you discuss your participation with your doctor, who may be able to support you in understanding the study better and helping you decide whether it is appropriate for you. During the trial, you will be under the care and supervision of the study doctor for all study-related procedures and care; however, you will still see your primary care doctor or specialist as normal for regular care. Lightship’s study team and study doctor are always on hand to talk to you or your doctor if there are any concerns or questions related to a trial.
What are my rights as a patient?
Patients are at the heart of everything Lightship does. We are committed to providing patients the best and most supportive service. To this end we have established the following patient bill of rights.