We often hear about Clinical trials in healthcare conversations, particularly when discussing new treatments or breakthroughs. They are the cornerstone of medical research and play an indispensable role in propelling medical science forward. While clinical trials are considered the "gold standard" for testing new drugs, you may also have heard about observational studies. You may also hear the term 'standard of care' often. It refers to the current best treatment or practice for a specific disease or condition. It is called standard of care since it acts as the comparison benchmark in clinical trials. Understanding the standard of care for your condition and the outocmes can help you grasp the potential benefits of other treatment options available for your condition.
Let's break down the differences between these two types of medical research so you can be an informed patient.
World Health Organization defines Clinical trials as a “type of research that studies new tests and treatments and evaluates their effects on human health outcomes”. Clinical trials equip us with valuable insights that pave the way for new therapeutic approaches and provides insight into the understanding of diseases.
Clinical trials often compare a new treatment to the existing standard treatment or a placebo (control). Patients are randomly assigned to either the treatment group or the control group, so there’s no accidental bias. Clinical researchers carefully design protocols that dictates dosages for new drugs, follow-up schedules, etc. They follow patients closely and study the impact of the drug on their health.
There are different phases of clinical trials. Phase I trials look at safety and side effects of an experimental drug or procedure. Phase II expands the testing to see if it works for a specific type of cancer. In Phase III, they test the new treatment against current standard treatments in a large group of people.
Based on the nature of the trial, there are various types of clinical trials such as preventive, screening, diagnostic, treatment, and quality of life trials. Randomized Clinical trials (RCTs) are treatment trials where patients are randomly assigned to either get the experimental treatment or the standard treatment/placebo. RCTs are considered as the gold standard.
Considering the Strengths and Limitations of participating in clinical trials is crucial:
Some of the Strengths include
Access to potentially innovative treatments that is not available to the public yet.
In-depth and attentive monitoring of your health.
The chance to contribute to medical research that may help future patients.
The experimental treatment may not be superior to, or as good as, the standard treatment.
Information regarding potential side effects may not be available.
The trial might require significant time and commitment, including additional medical appointments, treatments, and possibly complex dosage requirements.
You may get assigned to the control group and not the experimental treatment after all.
As we said earlier, clinical trials are so important because they ultimately shape the new standard of care for various cancers. They also take lots of time, money and patients involvement to run smoothly.
Emotional Aspects and Social Support
Joining a clinical trial can bring up a host of emotions that can range from hope about the possibility of a new, effective treatment to anxiety about the uncertainties, including potential side effects and the effectiveness of the treatment. Having the support of loved ones, healthcare providers, and other patients can make a big difference. Discuss the trials with your healthcare team, family, and friends and learn as much as you can beforehand. The decision to participate in a clinical trial is very personal; it depends on your unique circumstances such as your type and stage of cancer, your overall health, and your personal preferences. Make sure you spend time to understand the trial's purpose, procedures, risks, benefits, and how it may impact your daily life. This process, known as informed consent, is ensures the rights and welfare of the research participant.