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The Role of Placebo in Clinical Trials: Design and Ethical Considerations


Clinical Trial Design
Clinical Trial Design

First of all, placebo is an inactive substance or other intervention which looks the same as and is given the same way as an active drug or treatment being tested. Placebos are used in some clinical trials and research studies done with volunteers. The researchers may use placebos in cancer clinical trials to test whether the new drug or treatment works. It plays a vital role in the clinical trials. We will explore the role of placebo in clinical trials and its design and ethical considerations.


What is the Role of Placebo in Clinical Trials?


An inert substance known as a placebo mimics the medicine or treatment that is being examined. To determine if changes in the test group result from the treatment or happen by chance, the researcher examines the effects of the two groups.

Tests and placebos play a vital role. For example, early research by the National Institutes of Health (NIH) states that ginkgo biloba, an herbal supplement, might effectively delay dementia. So the National Institutes of Health (NIH) sponsored a 6-year, Phase 3 clinical trial with over 3,000 participants aged 75 and older.

However, in the end, the results of the scientists observed no significant differences in effect on dementia in adults who received ginkgo biloba or the placebo. Researchers got insights into the design and conduct of large dementia prevention trials in older adults.

The above is just one example on why placebo plays a vital role in clinical trials, and it helps to treat new drugs or treatment works.


Ethical Considerations


The use of placebos in clinical trials can raise several ethical concerns. Here are four key ethics considerations to keep in mind:

  • Respect for patient autonomy: Patients have the right to make informed decisions about their healthcare, including whether to participate in a clinical trial that involves a placebo. Healthcare providers must ensure that patients are fully informed about the risks and benefits of receiving a placebo and obtain the patient's informed consent before administering a placebo.

  • Non-maleficence: Healthcare providers must avoid causing harm to patients. While placebos are generally considered safe, there may be situations where using a placebo could lead to injury. For example, if a patient is not receiving adequate treatment for a severe medical condition, using a placebo instead of an active treatment could delay proper treatment and cause harm.

  • Beneficence: Healthcare providers must act in the best interests of their patients. While placebos may not have a direct therapeutic effect, they may be helpful in certain situations, such as managing pain or other symptoms. However, using a placebo should be carefully considered to ensure that it is being used to benefit the patient.

  • Design of Placebos: Placebos have a different format than active drugs. However, some patients may be disappointed that they received a placebo instead of an active drug. Therefore, healthcare providers should consider patients' expectations when choosing a placebo. In clinical trial design, the researchers prefer placebos for testing only when a gold-standard of treatment may not be easily available or when the true-effect of the test drug is to be ascertained.


Conclusion:


Placebos play a vital role in clinical trial services. Researchers can make use of placebos to study the effectiveness of new drugs and treatments. However, researchers have to be careful while designing clinical trials and ensure that their tests are ethical and that no harm is caused to patients.

Regulatory authorities and ethics committees do not generally favour the use of placebos in clinical trials where the subjects may be at harm of worsening of the existing disease/condition, leading to further complications and undue suffering, in the placebo arm. Such ethical and regulatory considerations should be paramount in the mind of researchers while designing clinical trials with placebo arms or groups.

Even patients/research participants do not proscribe to new treatments that are proven to be only marginally better than placebos. Healthcare practitioners and providers do not endorse such new treatments when other treatment options are available (even if they are not perfect) since managing patients’ conditions on existing therapies/treatments is easier and well-established.

As a thumb-rule, the placebo group should be avoided for better acceptance. Where placebo is the only choice, clinical researchers should take extra precaution while designing clinical trials to monitor each subject’s health condition and ensure that the trial has adequate safety measures in place from the beginning.


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