Clinical trials are the backbone of medical progress. They allow researchers to test the safety and effectiveness of new treatments, leading to the development of better ways to prevent, diagnose, and treat diseases. Your participation directly contributes to this advancement, potentially improving health outcomes for countless individuals in the future.

Clinical trials typically progress through four phases:

• Phase I: Focuses on safety and dosage. Involves a small group of healthy volunteers or patients to evaluate the treatment's safety, determine a safe dosage range, and identify side effects.

• Phase II: Tests effectiveness and further evaluates safety. Involves a larger group of patients with the specific condition to see if the treatment works and to continue monitoring for side effects.

• Phase III: Confirms effectiveness, monitors side effects, and compares to current treatments. These are large-scale studies (often hundreds or thousands of participants) comparing the new treatment to existing standard treatments or a placebo.

• Phase IV: Occurs after a treatment is approved. These studies monitor long-term effects, optimal use, and safety in a larger, diverse population once the treatment is on the market.

Not necessarily. Depending on the trial design, you might receive the investigational treatment, an approved standard treatment, or a placebo (an inactive substance that looks like the investigational treatment). This is done to ensure the study's scientific integrity and to accurately assess the new treatment's effects. You will always be informed if a placebo is used in the study as part of the informed consent process.

Informed consent is a crucial process where a member of the JCMLRI research team thoroughly explains all aspects of the clinical trial to you. This includes the study's purpose, procedures, potential risks, benefits, your rights, and alternatives. You'll have ample opportunity to ask questions. If you agree to participate, you will sign an Informed Consent Form, which is not a contract, and you can withdraw from the study at any time, for any reason, without affecting your standard medical care. 

Access to New Therapies: You may gain early access to cutting-edge treatments before they are widely available.

Expert Medical Care: You will receive close medical attention and monitoring from JCMLRI's specialist team throughout the trial.

Active Role in Your Health: You can play a proactive role in managing your health condition or contributing to general medical knowledge.

Contributing to Science: Your participation helps advance medical research, benefiting future patients and improving healthcare.

Potential Compensation: Some trials, particularly Phase I trials for healthy volunteers, may offer compensation for your time and travel.

While JCMLRI prioritizes your safety, all clinical trials carry some potential risks. These can include:

• Side Effects: The investigational treatment may cause unexpected or unpleasant side effects, ranging from mild to serious.

• Uncertainty: The new treatment may not be effective for you, or it might not be better than existing treatments.

• Time Commitment: Participation may require additional visits, tests, or procedures compared to standard care.

• No Guarantee of Benefit: There is no guarantee that you will personally benefit from the investigational treatment.

The research team will discuss all known and potential risks with you in detail during the informed consent process.

Your safety is our top priority. JCMLRI adheres to strict national and international ethical guidelines (including those from the Indian Council of Medical Research - ICMR). All trials are overseen by an independent Ethics Committee (like HREC-IILDS, registered with CDSCO and DHR, Govt. of India) that reviews and approves the study protocol. Additionally, our expert medical staff closely monitor participants for any adverse effects, and trials can be stopped if safety concerns arise. 

Healthy Volunteers: Typically participate in early-phase trials (Phase I) to help researchers understand how a new drug or treatment works in a healthy body, its safe dosage, and potential side effects before it's given to patients.

Disease-Specific Volunteers: Have a specific medical condition and participate in trials to evaluate the effectiveness and safety of new treatments for their condition. Their involvement helps determine if a treatment can improve their health or manage their disease.

Yes, confidentiality is paramount. All your personal and medical information gathered during the trial will be kept strictly confidential and used only for research purposes, as outlined in the informed consent form. Your identity will be protected in any publications or presentations of the study results.