Why Are Cancer Clinical Trials Important? What You Need to Know

Clinical trials are medical scientific studies involving people.

Through clinical trials, doctors find treatments for people with diseases and new ways to improve quality of life (the term clinical "research" is sometimes replaced by clinical "study" or clinical "trial" ).

We design new clinical trials in cancer for the following purposes:

• Treating cancer 
• Diagnosing cancer earlier and more accurately
• Preventing cancer
• Controlling side effects resulting from cancer treatment

A clinical trial is part of a process that starts in the laboratory and is completed after a long series of successive studies. Before using any new treatment in people in clinical trials, researchers spend many years studying its effects on cancer cells in the laboratory and in animals. They also try to understand the side effects that treatments may cause.

Each study has a person in charge, usually a researcher. The principal investigator prepares a plan for the study called a protocol. The protocol explains what will be done during the study. It also contains information that helps a doctor decide whether this treatment is right for you.

The protocol contains information about:

• Why the study is being conducted
• Who can participate in the study (eligibility criteria is the term used)
• How many people are needed for the study?
• The drugs or other treatments to be given, how they will be administered, their doses and how often they will be given 
• Which medical tests will be performed and how often
• What kinds of information will be collected about participants

Why are cancer clinical trials so important?

Today, people live longer thanks to successful cancer treatments resulting from past clinical trials. Through clinical trials, doctors determine whether new treatments are safe and effective and whether they work better than existing treatments. Clinical trials also help us find new ways to prevent and detect cancer. They help us improve people’s quality of life during and after treatment. When you join a clinical trial, knowledge about cancer increases, and you also help improve cancer care for future patients. Clinical trials are essential for progress in cancer medicine.

Worldwide, millions of people are living with cancer as never before. This progress is being achieved through important advances in medical research.

Researchers continue to make important discoveries in cancer surgery, chemotherapy, radiotherapy, immunotherapy and new drugs , enabling advances in their development.

One way patients can access promising new therapies is to participate in clinical trials, also known as cancer research studies.

Understanding cancer clinical trials

When a doctor recommends joining a clinical trial, they offer you the opportunity to go a step beyond standard treatment, to do a little more and access options that may benefit you even though they have not yet been proven.

However, clinical trials may not be the best choice for everyone. Deciding whether to join a clinical trial should involve weighing its risks or disadvantages against possible benefits with your family and doctors. Ultimately, participation in a clinical trial is your personal decision.

What is a clinical trial?

A clinical trial/research study tests promising new treatments with people at various stages of cancer, from early diagnosis to advanced disease.

A clinical trial is a test to find out whether a drug or treatment will be effective in treating a disease in humans. One percent of people receiving a drug or treatment for a disease receive that medication thanks to someone who participated in a clinical trial.

Clinical trials are an important part of proving that a new drug or treatment works for the group it aims to help. Most accepted uses of medicines today came from clinical trials. In the 1970s, for example, doctors and nurses began to think that aspirin could save the lives of people admitted to hospital with a heart attack. Because thousands of patients agreed to join an aspirin clinical trial more than 30 years ago, doctors now give aspirin to hundreds of thousands of patients each year.

A cancer clinical trial is one of the final stages of carefully conducted cancer research that begins in the laboratory. When doctors first discover a promising approach, they usually test it in animals. However, treatments that work well in animals do not always work well in humans. It is therefore important to study them in cancer patients to learn whether they are safe and effective for people. For patient safety, new treatments are tested in four stages (phases). Each phase is designed to answer different research questions.

• Phase-1 research involves a small number of people. Here we try to find a safe dose, decide how and when to administer the new drug, and determine how the new treatment affects the body.
• Phase-2 research determines a treatment’s effects on particular cancer types. If a treatment shows potential benefits, it moves to phase-3 research. This phase is open to large numbers of patients, and researchers use it to directly compare new treatments with standard treatments. This is how new standards are developed. Finally, phase-4 studies aim to further evaluate a treatment’s long-term safety and effectiveness.

There are many types of clinical trials , but all are designed to answer questions about early cancer detection, accurate diagnosis, treatment, managing side effects and cancer prevention .

Cancer has many stages and types. It is a very complicated/complex disease. We can conduct clinical trials at every stage of cancer. Separate clinical trials address cancer prevention, first-line treatments, first recurrence and second recurrence. It is not true that clinical trials are only for patients in the final stages (advanced disease, stage 4).

Many issues must be considered before you are offered the option of joining a clinical trial. First, researchers need to determine whether you meet the study’s specific eligibility criteria. Eligibility criteria differ for each study and may include factors such as cancer type and stage, previous cancer treatment and other health problems. Before joining a study, you may need to visit its clinic for tests and have your current doctor work with the study team. This helps ensure that a particular study is a good choice for you.

Even if you join a cancer clinical trial, you may not receive the new treatment being tested. This is due to the process of randomization (random assignment to groups), which helps ensure fair evaluation of different treatments. Randomization occurs in all phase-3 and phase-2 clinical trials. It means assigning patients to a study group or control group, with the assignment determined by chance using a computer program or a table of random numbers. If assigned to a control group, you receive standard treatment; if assigned to the study group, you receive the new agent or intervention being tested. Thus, even if assigned to the control group, you will receive one of the currently available approved treatments.

To help protect participants and produce reliable results, clinical trials follow strict scientific and ethical principles , with many reviews throughout the process. Participation in any research study has its own risks. To protect patients, clinical trials follow strict guidelines. These rules, called a protocol, act as a recipe for conducting a clinical trial.

The protocol ensures that all patients in the study are treated in the same way. For patient safety, each study must first be approved by an institutional review board consisting of leading researchers and community leaders. Some studies also continue to be monitored by a Data Safety and Monitoring Board to ensure that the trial is conducted correctly and its results are closely followed.

An important part of a clinical trial is a process called informed consent . During this process, your doctor or nurse explains the study’s terminology and treatments in detail. They also answer any questions you may have. Once you fully understand the study, its potential risks and benefits, and your rights as a participant, you will be asked to sign a consent form. This form is intended to ensure that you understand and accept the study’s terms.

You may wish to review the form with family or friends, or bring someone to the doctor’s office. It is very important to keep asking questions until you fully understand the study’s terms. If you choose to join a clinical trial, you retain the right to withdraw even after signing an informed consent agreement.

Participant safety will continue to be monitored throughout the study. If the review board or Data and Safety Monitoring Board concludes that a trial is causing unexpected harm to participants, the ethics committee may stop the study.

The idea that clinical trials are only for patients with very advanced disease and poor general health is one of many misconceptions about clinical trials. Another fear-based urban myth is the false claim that patients participating in clinical trials are treated like laboratory guinea pigs.

Another misconception concerns the use of placebos or sugar pills instead of treatments a patient may need.

Placebos are very rarely used during treatment in cancer clinical trials (only when there is no standard treatment for that condition). You will be told whether a placebo is used in the study.

Furthermore, if at any point during a study one group is clearly doing better, the study will be stopped and all patients will be offered the opportunity to receive the better treatment.

The greatest advantage of clinical trials is early access to a treatment—often a new drug—before it is approved for use. Another advantage is that all clinically eligible patients can participate regardless of their financial circumstances.

Clinical trials in Turkey

In Turkey, approving a new clinical trial and protecting the rights, safety and well-being of participants are the responsibility of independent Ethics Committees authorized in this area.

Under Supplementary Article 10 of the Basic Law on Health Services, research involving humans requires approval from the Republic of Turkey Ministry of Health or its affiliated institutions; the relevant Ethics Committee must also deem the proposed research appropriate. In other words, clinical trials undergo very rigorous approval and evaluation processes.

Most clinical trials conducted in our country are the Turkish arms of international clinical trials, providing an opportunity for our patients to access new drugs.

Conclusion

Clinical trials in cancer play an important role in discovering or developing newer, more effective drugs for all patients, while making important contributions to individual patients, offering opportunities and being closely monitored for patient safety.

Clinical trials are among the most valuable investments in a country’s health and future. Developed countries attach great importance and allocate funding to them for good reason. The best way to address the shortage of clinical trials or difficulty accessing them in our country is to educate the public and overcome the prejudice that clinical trials mean "experiments are being performed on people," refer our patients to clinical trials according to their eligibility, or make use of compassionate early-access programs. In this way, we take one of the most important steps toward giving our patients access to the right treatment options at the same time as the rest of the world.