Dr. Tushar Patil, a cancer specialist at Sahyadri Hospital, Pune, provides valuable insights into the purpose and process of clinical trials. In this discussion, Dr. Patil explains the scientific nature of clinical trials and the various phases involved in making new medicines available to patients.
What Are Clinical Trials?
Clinical trials are highly scientific studies conducted to test the effectiveness and safety of new medicines. These trials take place across multiple centres in India and abroad to ensure that only effective and safe medications reach the market. Dr. Patil explains that even common medications, such as Crocin, were once tested through clinical trials to evaluate their effectiveness before becoming available to the public.
The Phases Of Clinical Trials
Clinical trials are conducted in multiple phases to thoroughly assess a drug’s safety and effectiveness:
- Pre-Clinical Studies: Initial studies are conducted in laboratory settings (in vitro) or on animals to determine whether a drug has potential effects without major side effects.
- Phase 1: Human trials begin with a small group of healthy volunteers or patients. This phase assesses the drug’s safety and dosage.
- Phase 2: The trial is expanded to a larger group of patients to further evaluate effectiveness and monitor side effects.
- Phase 3: This final phase involves an even larger patient group, confirming effectiveness, monitoring side effects, and comparing it to other treatments.
Phase 4: After a drug is available on the market, post-marketing surveillance, or Phase 4, is conducted to track long-term effects and overall impact on patients.
The Role Of Clinical Trials For Patients
Dr. Patil highlights that clinical trials offer a valuable opportunity for patients, especially those with limited treatment options, such as those with advanced cancer. Some medications available internationally but not yet in India can be accessed through clinical trials, potentially offering life-changing benefits. Sahyadri Hospital’s Clinical Research Department is actively involved in trials across various fields, including oncology, haematology, neurology, medicine, and surgery, providing patients with access to new techniques, targeted therapies, and innovative treatments.
Accessing Clinical Trials Information
Dr. Patil encourages patients to explore clinical trial options for access to difficult-to-obtain medications. Information about available clinical trials in India can be found on websites like clinicaltrials.gov, which lists trial centres and provides details on available studies.
Safety And Scientific Rigour In Clinical Trials
Dr. Patil reassures that clinical trials are not unscientific experiments; they are conducted with the utmost scientific rigour to ensure patient safety. Sahyadri Hospital has provided many difficult-to-access medications to patients through these trials, serving as a significant resource for those in need.
For further information about clinical trials, patients are encouraged to contact Sahyadri Hospital at the numbers provided below.
Dr. Shama Shaikh-Surve
General and Laparoscopic Surgeon
Contact: +91 88888 22222
Email – ask@sahyadrihospitals.com
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