What are Clinical Trials?

Clinical trials are carefully designed research studies that test new medical treatments, drugs, vaccines, or procedures in people to evaluate their safety and effectiveness. These studies are essential for advancing medical knowledge and for making new therapies available to patients.
Clinical trials not only help doctors discover better treatment options but also give patients access to the latest therapies before they are widely available.

Types of Clinical Trials & Randomization

Different Types of Clinical Trials

1. Treatment Trials
   • Test new drugs, new combinations of drugs, new surgical methods, or radiation techniques.
   • Goal: To find better ways to treat patients.
2. Prevention Trials
   • Study ways to prevent cancer or other diseases in people who have never had them, or prevent a disease from coming back.
   • May include medicines, vaccines, vitamins, or lifestyle changes.
3. Screening Trials
   • Evaluate new methods to detect diseases at an earlier stage.
   • Example: Tests for early detection of breast or cervical cancer.
4. Diagnostic Trials
   • Aim to find better procedures or tests for diagnosing a particular disease more accurately or quickly.
5. Quality of Life (Supportive Care) Trials
   • Focus on ways to improve comfort and quality of life for patients with chronic or terminal illness.
   • Examples: Managing side effects like nausea, fatigue, or pain.

What is Randomization?

Randomization is a process used in many clinical trials to assign participants to different treatment groups by chance, like flipping a coin.

• Patients may be placed into either:
  • Experimental group – receives the new treatment being studied.
  • Control group – receives the current standard treatment or placebo (if ethically acceptable).

The assignment is done by computer, not by the doctor or patient.

Importance of Randomization in Clinical Trials

• Removes bias: Ensures doctors or patients do not influence who gets which treatment.
• Fair comparison: Makes sure that differences in outcomes are due to the treatment itself, not other factors.
• Reliable results: By equally distributing patient characteristics (like age, stage of disease, gender), randomization improves the scientific accuracy of the trial.
• Ethical practice: Gives all participants an equal chance to receive the new treatment.

Types of Clinical Trials

• Treatment Trials – Test new drugs, combinations, or procedures.
• Prevention Trials – Look for ways to prevent disease (medicines, vaccines, lifestyle changes).
• Screening Trials – Evaluate new tests to detect diseases earlier.
• Diagnostic Trials – Develop better ways to identify diseases.
• Quality of Life / Supportive Care Trials – Study ways to improve comfort and manage side effects.

Randomization Process & Its Importance

In many trials, patients are assigned to different treatment groups through a process called randomization. This means the patient is placed into a group by chance, not by choice.

• Why important?
  • Prevents bias.
  • Ensures fairness and equal chance of receiving either standard treatment or experimental treatment.
  • Improves reliability of study results.

Advantages of Clinical Trials for Patients

• Access to new treatments before they are widely available.
• Closer medical monitoring by doctors and healthcare staff.
• Opportunity to contribute to medical research that may help future patients.
• Sometimes, treatment and medical care costs are covered by the trial sponsor.

Disadvantages / Risks of Clinical Trials for Patients

• New treatment may not work better than standard treatment.
• Possible unknown side effects.
• More hospital visits, tests, or procedures may be required.
• In some cases, patients may receive the standard treatment instead of the experimental one (due to randomization).

How Can Patients Participate in Clinical Trials?

• Referral from doctor: Most patients are referred by their treating oncologist or physician.
• Trial centers / hospitals: Patients can directly approach hospitals conducting trials.
• Clinical trial registries: Many trials are listed on government or international websites (e.g., ClinicalTrials.gov, CTRI India).

Importance of Patient Consent

Before joining any clinical trial, patients must give Informed Consent. This means the study is explained clearly in a language the patient understands, covering the purpose, procedures, risks, and benefits.

What to Look for on the Informed Consent Form

• Purpose of the study.
• Details of the treatment, tests, and procedures.
• Possible risks and benefits.
• Other treatment options available.
• Confidentiality of patient data.
• Who to contact for questions or emergencies.
• Statement that participation is voluntary.

Rights of Patients in Clinical Trials

• Right to information – Patients have the right to know all details before agreeing.
• Right to withdraw – Patients can leave the trial at any time, without affecting their standard treatment.
• Right to confidentiality – Personal health information will be kept private.
• Right to equal care – Even if a patient withdraws, they will continue to receive appropriate medical treatment.
• Right to safety – Trials are approved by Ethics Committees to ensure patient protection.

Do Patients Have the Right to Withdraw Consent?

Yes. Patients may withdraw consent and stop participation at any stage of the trial, without giving a reason. Their regular medical care will not be affected.