Clinical Research FAQs
What is a clinical trial?
Clinical trials are a vital part of discovering and developing new treatments and an essential requirement from the FDA before a new drug is introduced for use. The primary purpose of clinical trials, also known as clinical research, is to determine whether a potential therapy or treatment would provide a new approach or better disease management when tested on human volunteers.
This treatment can be either a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.
The treatments whose safety profiles are satisfactory and demonstrate the most significant promise are then moved through the approval process by the regulatory agency.
What to expect in a trial?
Participants in all clinical trials receive care from a team of healthcare professionals, including doctors, nurses, social workers, and other healthcare professionals, led by a principal investigator who is also a doctor. The research team members will check participants’ health and review any special instructions before the start of the trial. Throughout the trial, the research team will administer treatment (either the experimental treatment, a standard treatment of care, and or a placebo, depending on the requirements of the study) and monitor the participant regularly to determine the effectiveness and side effects of the treatment. Communication is an essential aspect of any clinical trial. After the trial is over, the researchers will stay in touch for a specified period to assess any effects the treatment may have had after the treatment is over. Result generated during and after the trial are crucial to the drug’s approval submission to drug regulatory agencies.
Why should you participate in a clinical trial?
Participants in clinical trials are vital for developing and discovering new drugs; clinical trials provide knowledge and contribute to improvements in ways to treat and prevent disease. A decision to participate is one that the patient and their loved ones make together in close consultation with the physician and the research site. As participants, your contribution to medical knowledge and improvements in public health will have the most significant impact on others.
A clinical trial participant also does not need to be a patient diagnosed with a specific disease or health problem. Some studies will focus on safety and may include healthy volunteers as participants. Clinical trials may benefit certain participants, regardless of whether they have specific diseases or not. The important thing to remember is that no clinical trial can guarantee that the results will be as desired as the treatment being received in the trial.
Are there any risks or benefits associated with participating in a clinical trial?
Partaking in a clinical trial is an excellent way to contribute to one’s health care, gain access to medicines that may not be available for a significant period, and participate in improving the lives of others. However, your participation in a clinical trial may involve some risks, which your doctor will be able to describe to you in greater detail. Among these risks are:
Potential side effects of the drug may be known or unknown; risks associated with the study.
The investigational therapy may not work as well as the current standard of treatment, and there is also a possibility that it does not work for all patients.
Does participation in clinical trials involve a fee?
No, the participant is typically not charged for the experimental medication, the laboratory tests, and the procedures associated with the trial. However, it is important to note that the costs of routine tests and procedures – which are not related to the trial itself – are usually the participant’s responsibility or the participant’s insurance company. However, the participants receive compensation, which varies according to the clinical trial and the sponsor of the trial. Be sure to discuss this with the researcher before you decide to participate in a clinical trial.