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Basics of Clinical Trial Participation (by the CISCRP)

Watch this video by the Center For Info & Study on Clinical Research Participation (CISCRP) to learn more about participating in clinical trials.

Transcript:

0:00 Clinical trials are the best way to ensure that safe and effective new medicines can be developed for patients who need them.

0:08 Sometimes, clinical trials must adapt and change in response to major crises and challenges such as the COVID-19 pandemic.

0:17 At the same time, there are many important requirements of all clinical trials that continue even during these difficult times.

0:26 All clinical trials must follow a study design called a protocol and must gather evidence to answer questions about a therapy's safety and efficacy.

0:33 Many clinical trial designs use study blinding.

0:38 This is when participants or participants and researchers don't know which treatment participants are receiving.

0:43 Some trials are done this way because knowing what treatment the participants are receiving can affect the results of the trial.

0:50 Blinding minimizes bias.

0:53 All clinical trials are directed by study doctors, also known as principal investigators, and conducted by study staff to monitor participants' safety and help participants and their families.

1:04 All clinical trials involve careful monitoring from regulatory and ethical authorities to

help ensure the safety of study participants.

1:14 All clinical trials have an informed consent process so that participants can learn about all aspects of the study before deciding if they will agree to take part, and in all clinical trials, study participants can choose to end their involvement at any time.

1:32 All clinical trials should have a diverse group of study participants who reflect the population that will be using the new therapy.

1:39 Most clinical trials involve a comparison therapy to evaluate the new therapy.

1:44 The comparison therapy could be a standard treatment that has already been tested and approved.

1:50 It could also be a placebo.

1:53 A placebo looks like a treatment but does not have any medicine in it.

1:57 One way that researchers are working to adapt clinical trials is by making studies more accessible through virtual visits or by having a nurse or health professional visit the study participant's home.

2:07 These types of clinical trials may be safer for some participants during a crisis such as a pandemic and may be much more convenient for participants who live far away from a research center or have difficulty traveling.


2:22 What are virtual clinical trials?

  • Many trials that would have required visits to a health or research center are now moving to virtual visits to make participation more accessible.

  • These types of clinical trials are referred to by many names, including remote virtual sightless and decentralized clinical trials.

  • Trial participants still interact with the trial doctor and the trial staff.

  • They just do so by phone, computer, or other devices.

  • Sometimes trained nurses visit participants in their homes to do the trial procedures.

  • Job participants may be asked to visit the research center at certain times during the trial or for certain exams.


3:03 How do virtual clinical trials work?

  • In many virtual clinical trials, participants receive a smartphone or other handheld device pre-loaded with a trial application and a data plan.

  • This allows for secure video-based visits called telemedicine visits and direct communication with the trial coordinator at any time.

  • Trial participants might receive email and text reminders to complete questionnaires, perform a simple procedure or take the trial treatment.

  • Trial participants may also receive devices like a Fitbit or smartwatch to collect their own health data, such as blood pressure, temperature, and pulse rate.


3:43 What does an in-home visit look like?

  • Nurses who visit trial participants' homes receive training on the clinical trial design and follow strict quality control requirements.

  • They typically bring the required equipment to conduct procedures in the same way they would at the clinical trial site.

  • They usually process the samples in the participant's home and then send them to the lab for analysis.


4:08 What happens when a trial drug is being tested in a virtual trial?

  • For some virtual clinical trials, the trial drug is shipped directly to a participant's home.

  • The participant and their caregivers may receive instructions on taking the trial drug themself, or they may have a visitor nurse give them the trial drug at home.

  • Trial participants are often asked to record when they take the trial drug, often using an electronic diary or a smartphone, and some trials may include an automatic tracking device in the package of the trial drug or even a mini refrigerator that monitors temperature and when the trial drug is taken.


5:00 What can I expect if my clinical trial is suspended?

  • Sometimes clinical trials are suspended, meaning that they are stopped for one or more reasons.

  • In an emergency situation like the COVID-19 pandemic, clinical trials may be suspended while the research team faces new challenges.

  • Clinical trials for serious illnesses, such as cancer and certain rare diseases, are rarely suspended.

  • If you are a trial participant whose clinical trial is suspended, communication is very.

  • The research team will reach out to you with updates and keep you informed about

  • In the meantime, you can keep track of changes to your health and any other information that you want the research team to know.

  • Once the trial reopens, if your clinical trial is suspended, your data and information are not thrown out, deleted, or lost.

  • Your participation continues to be extremely valuable.


5:54 If I participate in a clinical trial during a public health crisis or other emergency, how will my safety be protected?

  • Clinical trials have different ways of protecting study volunteers during emergencies.

  • Virtual clinical trials offer convenience, flexibility, and reduced risk of exposure to study.

  • If the clinical study involves in-person visits, study clinics will minimize contact by asking study volunteers to wait in their cars or by calling ahead to ask health-related questions.

  • Study staff and volunteers will also be asked to wear personal protective equipment.

  • Study volunteer safety remains very important, especially in emergency situations.


6:41 What are some questions I can ask the trial doctor and trial staff to help me decide whether to participate in a virtual clinical trial?

  • So you might want to ask how and when the trial visits will occur and if you have a choice about whether to participate virtually, in person, or through a hybrid approach that includes both types of visits.

  • If you're comfortable with the trial representative or nurse coming to your home, feel free to ask if the same person will visit each time and what type of training that they have.

  • You can also schedule a time to meet the representative or nurse and discuss any concerns before an in-home visit begins.

  • You can also ask how often the visits will happen and how long they will last.

  • The research team can walk you through any medical tests or procedures required, and you can ask how you'll receive the trial drug and how technology issues will be supported, and you can ask how your safety and privacy will also be protected and whom you can speak to about any questions during the clinical trial.


7:43 Virtual clinical trials offer convenience to participants, but they also place more responsibility

on the participants since in-person visits happen less often.

7:51 If you participate in a virtual clinical trial, you'll need to follow the trial plan called the protocol.

7:58 You'll also need to take the trial drug on time.

8:01 You may have to perform certain tests yourself.

8:05 You'll also need to receive and send materials, stay connected, and use technology.

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