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Understanding Clinical Trials

Clinical trials are research studies

that evaluate new ways to improve treatments

and quality of life for people with diseases

like pancreatic cancer.

Clinical trials are an option for all patients to consider

and play an important role in improving healthcare.

Results from clinical trials help develop new drugs,

new diagnostic tools,

and new clinical procedures.

Clinical trials can also spur new questions for research,

which lead to new discoveries over time

and help us to better understand diseases

like pancreatic cancer.

All the drugs and tools we have today

were made possible because patients

volunteered for clinical trials.

Every clinical trial has what are called “eligibility criteria”.

For example, a patient may need

to have a certain medical condition,

or gender, or other specifics

to meet the criteria of participating in the clinical trial.

Otherwise they are not eligible to join that clinical trial

and could seek another trial that better fits their situation.

Patients who want to volunteer

need to understand the potential benefits and risks

of participation in a clinical trial.

Patients may personally benefit

from receiving new therapies or procedures.

They receive close supervision from clinical staff.

Sometimes the cost of the new drugs or testing is free or waived.

Participants may also be part of a research breakthrough

that helps thousands of future patients.

Patients face the risk

that they may not benefit from the new treatment.

Additionally, participating in a clinical trial requires commitment.

Trials can be lengthy or demanding,

and may require extra treatments,

extra time in the clinic,

or tests or costs that are not part of standard care.

It is possible, if the study is randomized,

that they may be part of the control group

that does not receive the new drug being studied.

“Informed consent” is a process that helps patients

make an informed decision about whether to join a clinical trial.

An “informed consent document” will be provided

that explains the purpose, procedures,

and potential benefits and risks of the trial.

There will also be thorough discussions

between the doctor and patient

so that all questions can be clearly answered.

In late-stage clinical trials,

participants are generally split into 2 groups

at the beginning of the study.

One group receives the standard treatment plus the new treatment.

This group is called the “Treatment Group”.

The other group receives the standard treatment only,

and does not receive the new treatment.

This group is known as the “Control Group”.

A computer is used to randomly assign the patient

to either the Treatment Group or the Control Group.

Randomization helps to prevent bias

because neither the patient nor the doctor can choose

which treatment group a patient is assigned to.

Some clinical trials may want to study the effectiveness

of adding a new treatment to a standard treatment

to see what works better.

In these studies, half the patients will receive

the standard treatment plus the new treatment,

and the other half will receive

the standard treatment plus a “placebo”.

A “placebo” is a treatment that looks identical to the new treatment,

but contains no active ingredient.

These types of studies are often called “blinded",

meaning that one or more parties involved in the trial

do not know which patients have been assigned to which treatment.

“Single-blinded” means that only one party

(either the researchers or the patients)

knows which patients have been assigned to which treatment.

“Double-blinded” means that both the researchers

and the patients do not know

which patients have been assigned to which treatment.

The strongest, most reliable results

come from clinical trials in which the treatment is double-blinded,

the patients are randomized,

and the study has a control group.

This is called a “double-blinded, randomized, controlled clinical trial”.

Clinical trials are carefully monitored to protect patients,

and several layers of review committees are involved

to protect patients from any possible harm.

Patients can leave a clinical trial at any stage.

However, they should discuss this with their doctor before exiting,

to ensure the safest procedures are followed.

There are 4 different phases of clinical trials.

Safety is emphasized in each phase.

If a trial does not have a positive or safe outcome in Phase 1,

then it will not be allowed to proceed to a Phase 2 trial, and so on.

Before a Phase 1 trial begins, there is a Phase 0,

where the new treatment has already been found

to be safe in animals or healthy human volunteers.

In Phase 1 clinical trials,

a new treatment is tested in a small group of participants

for the first time to determine a safe dose

and see how the treatment affects the body.

Phase 2 is conducted with a larger patient group

than the previous phase

and studies how well a new treatment or combination of treatments

works for a certain type of cancer, like pancreatic cancer.

At this stage the eligibility criteria become more restrictive.

Phase 2 studies can be either randomized or non-randomized.

Phase 3 trials are conducted in an even larger group of participants.

This phase involves a randomized design,

comparing the new treatment to the standard treatment.

If a Phase 3 clinical trial is positive,

typically the new treatment will be approved

and licensed for use in the United States

by the Food and Drug Administration (or FDA).

After the treatment has been approved,

Phase 4 clinical trials involve monitoring

to continue to assess safety, effectiveness, and optimal use.

Clinical trials play an important role in moving science forward

and can be a hopeful option for many patients with pancreatic cancer.

To learn more about clinical trials and how to participate in one,

please talk to your doctor.

You can also visit

The National Pancreas Foundation’s Clinical Trial Resource Centre

at www.PancreasFoundation.org

and the ClinicalTrials.gov website to learn more.