About Clinical Trials – Sparrow Search

Listen to the Podcast of this Article:

Why join a clinical study?

Joining a clinical trial may provide medical benefits to you, but there are also potential risks and uncertainties involved. Individuals should carefully consider the study’s potential risks and benefits, and they must be fully informed about the procedures, possible side effects, and potential outcomes before deciding to enroll. It is recommended that you discuss participation in a clinical trial with your doctors and that you make an informed decision based on your individual circumstances.

What is Sparrow Search?

Sparrow Search is a “self-service” online tool that allows individuals to complete a brief Clinical History and receive a list of clinical studies for which they may be eligible- in their desired locations . Sparrow Search is built from a database of studies published on ClinicalTrials.Gov, which is provided by the National Institutes of Health. Clinicaltrials.gov includes clinical studies that are happening now, will happen soon, or happened in the past (completed, terminated, withdrawn, or suspended). The Sparrow Search database includes only studies that are active, which means that they are looking for participants (“recruiting”) or will soon be looking for participants (“not yet recruiting”.) These are also called “open” studies because they are looking for participants. “Completed”, “terminated”, “withdrawn”, and “suspended” studies are considered “closed” studies, which means that they are not looking for participants.

Right now, Sparrow Search includes only open prostate cancer studies. Next we will develop Sparrow Search for dementia clinical trials, and then other serious medical conditions.

About clinicaltrials.gov

Clinicaltrials.gov is a place to learn about clinical studies from around the world. It is used by the public, researchers, and healthcare professionals. It is provided by the National Library of Medicine at the National Institutes of Health (NIH). The U.S. government does not review or approve the safety of all studies listed on this website. The study sponsor or investigator is responsible for the safety, science and accuracy of any study they list on ClinicalTrials.gov. A study “sponsor” could be a pharmaceutical company that is developing a drug.

Clinicaltrials.gov lists up-to-date information on clinical research studies, with new studies added almost every day.
It includes studies that take place in all 50 states and over 200 countries.
There are 84,892 studies on clinicaltrials.gov that are looking for participants or will be shortly.
There are 1,336 prostate cancer studies on clinicaltrials.gov that are looking for participants or will be soon.

ClinicalTrials.gov does not include very single clinical trial happening in the United States or around the world. Some studies may not be included because it’s not required that they register with clinicaltrials.gov, and some are not there because the study sponsor did not register the study, as required.

Despite its name, it’s important to know that not all studies in Clinicaltrials.gov are what we usually think of as clinical trials. Clinicaltrials.gov includes classic clinical trials and many other types of clinical studies. What we usually think of as a clinical trial is a study of a new drug treatment for a medical condition where people are split into different groups. One group receives the new drug and the other does not, and then we compare what happens to people in both groups, to decide whether the new drug is safe and effective.

However, not all studies are “treatment” studies. The main purpose of some studies could be to test a new type of prevention for the medical condition, a new way to diagnose the condition, or basic science research about the condition.

Here are some examples of different types of studies in Clinicaltrials.gov and their primary purpose:

Prevention. Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
Screening. MRI Versus PSA in Prostate Cancer Screening

Basic science. Urinary and Prostate Microbiotes and Prostate Cancer
Health Services Research. Cost Talk: Discussing Cancer Care Costs

Treatment (drug): Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Treatment (radiation): Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer

What is a clinical study?

A clinical study is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. The goal is to use science to improve people’s health care and health over time. The people who join clinical research studies may or may not get any benefit for themselves.

Researchers learn:

How the body works
How illness develops in people, such as how diseases get better or worse over time
How the body handles a possible treatment
Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness

Clinical trials are one type of clinical study, and clinical trials are used to test medical, surgical, behavioral, or other “interventions” in people. New drugs and vaccines must undergo clinical trials to be approved by the U.S. Food and Drug Administration (FDA) for use by the public.

There are two types of clinical studies

Sparrow Search includes what we usually think of as clinical trials (also known as “interventional” studies), as well as “observational” studies.

In a clinical trial, researchers put (“assign”) people in the study into different groups. One group will receive the study intervention, and the other group(s) will receive a “placebo” (fake medicine) or “standard of care” (regular treatment for the illness.) The purpose is to see if people receiving the study intervention get better, compared to people who receive a placebo or regular care. The intervention could be a new drug, medical device, or procedure such as radiation. Interventions could also be related to your lifestyle, such as education, diet, exercise, or meditation.

In many clinical trials, researchers randomize (assign) people to the different groups randomly, like rolling a dice. If you are in a study that is “randomized”, you may not get the study intervention. You may be in a group that receives a placebo, or a group that receives “standard of care”.

In observational studies, the study investigator does not assign people to different groups. We compare what happens in different groups of people, but the people are not assigned to the groups. An example would be a study of the diet of people who are overweight, compared to the diet of people who are not overweight. It is not ethical to assign people randomly into an “overweight” group and a “not overweight” group.

When are clinical trials required?

Clinical trials are typically required during the development of new drugs, medical devices, biologics, or treatment protocols. Countries are different in when they require that a clinical trial be done.

Generally, you must conduct a clinical trial if you are developing:

New Medications or Treatments. Usually, you must conduct a clinical trial before a new medication or treatment can be approved for use by the public. This allows researchers to understand the drug’s effectiveness, side effects, and potential interactions with other substances. We also find out how much of a new medicine to give to people (“dosage”) through clinical trials.
Medical Devices. New medical devices also require clinical trials. These trials assess the safety and effectiveness of the device. For example, if a company developed a new type of pacemaker, it would need to conduct clinical trials before it could be approved for use in patients.
New Uses for Existing Treatments. If an existing drug or treatment is being considered for a new use (“off-label use”), then clinical trials may be necessary. This can happen when a medication designed to treat one disease is discovered to potentially have beneficial effects on another disease. For example, if scientistis think that a gout medicine that is already on the market might be useful in treating arthritis, we must conduct clinical trials of the medicine among people with arthritis in order to market that medicine as an arthritis treatment.
Comparing Treatments. Clinical trials can also be used to compare the effectiveness of two or more existing treatments. This can help determine which is the most effective, or if they have similar effects, which one has fewer side effects. For example, a clinical study that compares two treatments for ADHD may find that the first medicine is more effective than the second medicine, but it has more negative side effects.
Improving Existing Treatments. Sometimes, clinical trials are conducted to improve the effectiveness or reduce the side effects of an existing treatment. This could involve changing the dosage, combining the treatment with another one, or changing how it’s administered. In cancer clinical trials, there are many “combination studies” that test whether two drugs given together are more effective in treating the cancer than giving the patient just one drug.
Vaccines. Clinical trials are mandatory for vaccines to ensure they are safe and effective before they are made available to the public.
Preventive Measures. Clinical trials are also conducted to test measures meant to prevent illnesses, such as dietary supplements, lifestyle changes, or preventive drugs.

If the treatment or device shows promise and is deemed safe and effective in clinical trials, it can then be considered for approval by regulatory bodies such as the Food and Drug Administration (FDA) in the United States. FDA approval allows us to sell the treatment (device or vaccine) for use by the public. After FDA approval, post-market surveillance trials (Phase IV) may be done to monitor the drug or device’s long-term effects in a larger population.

What is expanded access?

Expanded access is a way for a patient with a serious illness who cannot participate in a clinical trial but has no other treatment options to receive an intervention that is still being studied in clinical trials and not yet FDA-approved. Expanded access is not clinical research– and is not available for all interventions being tested. It is also called “compassionate use.”

There are different types of expanded access:

Available. Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
No longer available. Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
Temporarily not available. Expanded access is not currently available for this intervention but is expected to be available in the future.
Approved for marketing. The intervention has been approved by the U.S. Food and Drug Administration for use by the public.

Who carries out clinical studies?

The study sponsor is the person or organization that is responsible for a clinical study. A sponsor could be an organization such as a drug company, clinic, or research institute. It could also be a doctor or scientist who may work at a university or clinic.

The person leading a research study is called the principal investigator (PI). The PI is usually a medical doctor or a scientist. The PI leads a team of staff that includes other doctors, study managers, and clinical research coordinators. A clinical study is carried out at many clinical research sites around the U.S. and in other countries. A site could be a medical clinic in the community, an individual doctor’s office, a university medical center, or a separate “clinical research site” that only does clinical studies and does not provide regular medical care.

What information does Sparrow Search provide about prostate cancer clinical studies?

Right now, Sparrow Search includes “open” (recruiting or not yet recruiting) studies for prostate cancer. Soon it will include open studies for dementia (including Alzheimer’s Disease) and other diseases.

For each “open” study, Sparrow Search provides this information:

Name of the study and a description
The person or organization responsible for the study (study “sponsor”)
Name of the people or organizations that pay for the study
The beginning and end dates of the study
Locations- clinics where the study is being held. Note that one study can be conducted in many different locations (“sites”) throughout the U.S. and abroad. Also, a trial may be “open” (recruiting or not yet recruiting), but some sites might be closed to recruitment. Maybe the site has already met their enrollment goal, or perhaps it was not able to recruit enough people and closed.

Sparrow Search includes detailed information about each prostate cancer study:

The primary purpose of the study (treatment, basic science, or something else).
A description of the intervention(s) (such as a drug, medical device, or radiation)
How many people are needed for the study (enrollment)
Who can and cannot join (eligibility criteria)
Whether participants will be “randomized” into different study groups

Clinical trials have stages (“phases”)

A new medicine that will be marketed in the U.S. must be approved by the U.S. Food and Drug Administration (FDA). To be considered for approval, it must go through several stages of testing which show that the medicine is safe and effective (it makes you better). These stages of testing are called “phases.” Interventional studies have phases, but observational studies do not.

A trial must be successful (the intervention is safe and effective) in one phase before it can go on to the next phase. If a Phase 1 trial is not successful , the trial will not go on to Phase 2. The trial will be terminated. [Trials may also be terminated for other reasons- maybe they were not able to enroll enough people, or maybe the sponsor decided to stop development of the product.]

Early Phase 1 (formerly listed as Phase 0)

These are exploratory studies to investigate whether and how the drug affects the body.

Phase 1

Phase 1 studies look at the safety of an intervention (such as a drug or radiation). They are usually done with healthy volunteers who do not have the study illness. The goal is to determine the side effects of the intervention, and how a drug is broken down and excreted by the body. These studies usually include a small number of people.

Phase 2

Phase 2 studies gather early data on whether an intervention works (effectiveness) in people who have the study condition. People who receive the study intervention will be compared to people in the other groups who do not receive the intervention to see if their health has improved.

Phase 3

Phase 3 studies collect more information about an intervention’s safety and effectiveness by studying the intervention in different groups of people and different doses and by using it in combination with other drugs. These are large studies that could involve hundreds or thousands of participants, conducted in many countries. They are very expensive and may take up to 3 years to complete.

Phase 4

Phase 4 studies happen after the intervention has been approved by the FDA. The earlier phases of testing were done with fewer people, so there might be some things we didn’t learn about the intervention until it is used by more people. For example, a medicine might have a rare side effect. We might not have seen this side effect in the earlier phases of testing because they included fewer people.

Phase Not Applicable

Clinical trials of medical devices and behaviors (such as meditation) do not have phases. Observational studies also do not have phases.

Who can join a clinical research study?

If you are interested in a clinical study, you may or may not be able to join the study. Each study has a unique set of eligibility criteria. People who want to join a clinical study must meet these requirements. Eligibility criteria include inclusion criteria (characteristics that the person must have to participate in the study) and exclusion criteria (characteristics which will prevent you from enrolling). Researchers use eligibility criteria to keep participants safe, and enroll the right people. There may be many eligibility criteria for a study, and they are very precise.

Inclusion criteria for a prostate cancer study might include:

Metastatic disease
Castrate-resistant prostate cancer
Good health (able to perform activities of daily living)

Exclusion criteria for a prostate cancer study might include:

Autoimmune disease
Serious heart disease
A second cancer (non-prostate)
History of HIV

Who pays for clinical studies?

On the Trial Detail page for studies in Sparrow Search, we list the Sponsor and Collaborator(s) for the study.

The study sponsor is the organization or person who initiates the study and who has authority and control over the study. A sponsor might be a drug company, such as Pfizer.

A collaborator is an organization other than the sponsor that provides support for a study. The collaborator might provide additional funding, help design the study, or help with data analysis. A collaborator might be a smaller pharmaceutical company, such as Takeda Pharmaceuticals.

Individuals, companies, or organizations listed as sponsors and collaborators are considered the funders of the study. Not all studies are funded by industry. Many are funded by individuals or universities.

Sparrow Search lists four types of funders:

U.S. National Institutes of Health (NIH)
Other U.S. Federal agencies (for example, Centers for Disease Control and Prevention, or U.S. Department of Veterans Affairs)
Industry (for example, pharmaceutical and medical device companies)
All others (individuals, universities, and community-based organizations such as the Prostate Cancer Foundation)

Some additional terms used in clinical studies

Allocation

Allocation explains how participants are assigned to different groups in a clinical study. The types of allocation are randomized and nonrandomized.

Contact

The name and contact information for the person who can answer enrollment questions for a study. Each location (“site”) where the study is being conducted may also have a unique contact, who may be better able to answer those questions.

Enrollment

The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study.

First posted

The date on which the study record was first available on ClinicalTrials.gov.

Informed consent

A process used by researchers to communicate to potential and participants the risks and potential benefits of participating in a clinical study.

Investigator

A researcher involved in a clinical study. Other terms include principal investigator and study director.

Patient registry

A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.

Placebo

An inactive substance or treatment that looks the same as an active drug or other intervention being studied.

Primary completion date

The date on which the last participant in a clinical study was examined or received an intervention.

Primary purpose

The main reason for the clinical study. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.

Recruitment status

Looking for participants
- Recruiting. The study is currently recruiting participants.

- Not yet recruiting. The study will soon be enrolling participants.

- Enrolling by invitation. The study is selecting its participants from a group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular group, who are specifically invited to participate.

No longer looking for participants
- Active, not recruiting. The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

- Completed. The study has ended normally, and participants are no longer being examined or treated.

- Terminated. The study has stopped early and will not start again. Participants are no longer being enrolled.

- Suspended. The study has stopped early but may start again.

- Withdrawn. The study stopped early, before enrolling its first participant.

- Unknown. A study whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been verified within the past 2 years. An “unknown” study is considered a closed study.

- Other

Expanded access. A way for patients with serious diseases who cannot participate in a clinical trial to gain access to a product that has not yet been approved by the FDA. Also called compassionate use.

Study documents

These include a study protocol (document that outlines the design of the study), statistical analysis plan, and informed consent form.

Study ID

The unique identification code given to each clinical study when it is registered at ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number (for example, NCT00000419).

Study resources

Scientific publications related to the intervention being tested in the study. Also, websites about the study.

Study start date

The date on which the first participant was enrolled in a clinical study.

Study type

Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.