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All of us have been to doctors and have been prescribed drugs. The first question that arises in our minds is that whether these are safe. Did you know that these drugs pass through a lot of procedures called ‘clinical trials’ to ensure their safety and efficacy?

Modern medical advances have helped millions of people live longer, healthier lives. We owe these improvements to decades of investment in medical research.

Ancient civilizations relied on medical observation to identify therapies that worked, and those that did not. Beginning in the early twentieth century, therapeutic reformers in the United States began to develop the concept of the clinical trial.

Clinical trials are experiments or observations on human participants and are designed to answer specific questions about new treatments (such as new vaccines, drugs, dietary choices, dietary supplements, and medical devices). Clinical trials generate data on safety and efficacy that are later analyzed by the FDA on whether these are safe and efficacious enough to be approved for release in the market.

Clinical trial participation is completely voluntary and is overseen by an ethics committee that ensures that the conduct is fair to the participants.

Clinical trials can help:

  • prevent diseases by testing a vaccine
  • detect diseases or conditions, for example by testing a blood sample
  • treat diseases or conditions by testing a new medicine/device or any medical procedure
  • find out how people can control their symptoms or improve their quality of life. E.g.: by testing how a diet affects a condition.

Clinical trials also help to improve health care by raising standards of treatment. Doctors and hospital staff involved in clinical trials are continually trained to provide best patient care.

Initially, the interventions are tested in animals, called preclinical studies and are submitted to the FDA for permission to test in humans. Clinical trials in humans usually take place in 4 phases-

  1. Phase 1, where the drug is screened for safety in a small group (typically 20–80) to evaluate safety, determine safe dosage, and begin to identify side effects.
  2. Phase 2, where the drug is tested, usually against a placebo/comparator in a larger group (typically in hundreds) to determine efficacy and to further evaluate safety.
  3. Phase 3, where the final confirmation of safety and efficacy is done with large groups (typically in thousands) to evaluate its effectiveness, monitor side effects, compare it to other commonly used treatments, and to collect information.
  4. After completion of phase 3, the new drug application (NDA) is submitted to the FDA to gain approval for marketing. Please note that all submitted NDAs are approved only after rigorous evaluation and review.
  5. Phase 4 is conducted after the drug is marketed to gain additional information, usually regarding its safety (Particularly after approval under FDA Accelerated Approval Program).

The clinical research field is a lucrative career field for not only doctors and nurses, but also for paramedical and life science undergrads and those interested in research. For more information, continue watching out for more articles on clinical research and related topics.

(Dr. Nisha Nair is director of the Pacific Biosafety Group. She is an industry consultant in the field of clinical research, medical writing and pharmacovigilance, a trainer and career counselor for those in the biopharmaceutical industry and academia that want to get into these fields. For more information, please contact: dr.nishaputhiyedath@gmail.com)

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