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Understanding Clinical Trials

What are Clinical Trials?

Clinical trials are a type of research that studies and establish the safety and efficacy of any new drug in human population.
Clinical trials are carefully designed, conducted, documented and reported to ensure the rights, safety, and well-being of the trial subjects. People of all ages can take part in clinical trials, including children.
Medicine and patient care have evolved over time. But this would not have been possible without the revolutionary advances made through clinical trials and without the people who have volunteered to participate in these clinical trials. Every drug, device, test, tool, technique and technology used in medicine today was once tested in volunteers who took part in clinical trials.

Clinical trials are typically conducted in four phases

Each stage of a clinical trial has its own purpose in ensuring that a drug is safe and effective for use by the public.

  • Phase I trials test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
  • Phase II trials test new drugs in a limited number of patients to determine possible therapeutic uses, effective dose range and further evaluation of safety (after the new drugs are found safe in Phase I).
  • Phase III trials are conducted to obtain sufficient evidence about the efficacy and safety of the new drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate, after the preliminary evidence accumulated in Phase II that a drug is safe and effective for use in the intended indication and recipient population. Phase III studies are often the stage right before a new treatment is approved.
  • Phase IV trials of new drugs are performed after the approval of the drug and related to the approved indication. These studies are important for optimizing the use of the product.

Clinical Trials –Risks versus Benefits

Each clinical trial has its own benefits and risks. Some of the potential benefits of clinical trials include:

  • Offer patients opportunities to receive new treatment which is not available outside the trial (early access to new treatments) which might be safer or effective than current options.
  • Long-term societal gains through better health outcomes and improving treatment options.
  • Offer patients to feel more control by taking a more active role in their health care.
  • Offer patients to receive specialized care and close monitoring
  • Facilitates medical knowledge dissemination and innovation
  • Offer patients financial support, as some clinical trials may pay for part or all medical care and other expenses during their participation in the trial (This may not hold true for all clinical trials).

Some possible risks of being in a clinical trial can include

  • Patients may have unknown side effects or other risks with the new treatments which might be worse than those from standard approved treatments.
  • The new treatment may not provide intended therapeutic effect.
  • Patients can have more frequent visits for trial related procedures which can be little time consuming for them.
  • In case of a randomized clinical trial, patient may not have a choice on which treatment they get. In blinded trial, patient (and maybe the trial doctor) won’t know which treatment patient is getting (This information will be available to the clinical trial team as needed for patient’s safety).
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