WHAT IS CLINICAL TRIALS?

Clinical trials are investigations created to assess the safety and efficacy of novel medical treatments, interventions, or procedures. Within the realm of oncology, these trials serve as critical avenues for advancing the comprehension and management of diverse cancer types. These trials aim to improve existing therapies, discover novel treatments, enhance diagnostic methods, and explore preventive measures for cancer.

At Nosworthy Oncology, we prioritise clinical trials as a cornerstone of our dedication to delivering top-tier care to our patients. Engaging in these trials grants patients access to innovative treatments that might not otherwise be accessible through conventional care avenues. Moreover, these trials contribute to the collective knowledge base of the medical community, ultimately benefiting future generations of cancer patients.

HOW DOES CLINICAL TRIALS WORK?

Clinical trials typically follow a structured protocol designed to safeguard patient safety and collect rigorous scientific data. The process involves several key phases:

  1. Preclinical research: Before initiating a clinical trial, thorough preclinical research is conducted in laboratory settings to evaluate the efficacy and safety of the treatment. This stage typically includes testing the treatment on cell cultures or animal models.
  2. Phase I trials mark the first step in assessing a new treatment in humans. These trials primarily focus on determining the safety and dosage of the treatment. Usually, a small group of patients, often those with advanced cancer who have undergone standard treatment options, participate in Phase I trials.
  3. Phase II trials: Should a treatment demonstrate promising outcomes in Phase I trials, it advances to Phase II trials. These trials involve a larger patient population and aim to further examine the safety and effectiveness of the treatment. Additionally, researchers gather more data regarding the optimal dosage and potential side effects.
  4. Phase III trials: Phase III trials compare the novel treatment to standard treatments or a placebo within a substantial patient cohort. These trials furnish crucial evidence concerning the treatment's efficacy and potential advantages compared to existing options. Randomisation and double-blinding techniques are frequently employed to minimise bias and ensure the reliability of the findings.
  5. Phase IV trials: Phase IV trials, also known as post-marketing studies, occur after a treatment has been approved by regulatory agencies and made available to the public. These trials continue to monitor the treatment's safety and effectiveness in real-world settings, often focusing on long-term outcomes and rare side effects.

Throughout each phase, clinical trials adhere to strict ethical and regulatory standards, with oversight from institutional review boards (IRBs) and regulatory agencies such as the Food and Drug Administration (FDA).


HOW DO YOU CONDUCT TRIALS WORK?

Implementing clinical trials requires a multidisciplinary approach involving healthcare professionals, researchers, regulatory bodies, and patients. At Nosworthy Oncology, we have a dedicated team of oncologists, nurses, research coordinators, and support staff who collaborate to ensure the successful implementation of clinical trials.

  1. Patient recruitment: Identifying eligible patients and obtaining their informed consent is a crucial initial step in administering clinical trials. Our team educates patients about the purpose of the trial, potential risks and benefits, and their rights as participants.
  2. Treatment administration: Once enrolled, patients receive the investigational treatment according to the trial protocol. Our experienced healthcare providers closely monitor patients throughout the trial, conducting regular assessments to track treatment responses and detect any adverse effects.
  3. Data collection and analysis: Accurate data collection is essential for evaluating the outcomes of a clinical trial. Our research coordinators meticulously document patient information, treatment administration, and clinical outcomes according to the trial protocol. Statistical analysis of the data provides valuable insights into the efficacy and safety profile of the treatment.
  4. Regulatory adherence: Ensuring compliance with regulatory obligations is essential for upholding the integrity of clinical trials. Our team diligently ensures that all facets of the trial strictly adhere to ethical principles and regulatory mandates established by Institutional Review Boards (IRBs) and regulatory bodies. This encompasses meticulous record-keeping, prompt reporting of adverse events, and strict adherence to protocol amendments.
  5. Patient support: Engaging in a clinical trial can present substantial hurdles for patients and their families. Our committed support team provides a wide array of inclusive services, including counselling, symptom management, and facilitation of resources designed to meet the diverse physical, emotional, and practical requirements of patients as they navigate their trial experience.
 

FREQUENTLY ASKED QUESTIONS

 
How can I determine if I qualify for participation in a clinical trial?
Eligibility criteria differ based on the particular trial, encompassing variables such as cancer type, stage, prior treatments, and overall health. Your oncologist and the research team will evaluate your eligibility according to these parameters.
will I receive personalised care during a clinical trial?
Yes, patients enrolled in clinical trials receive personalised care tailored to their specific needs. Our multidisciplinary team of healthcare professionals closely monitors your progress, provides support, and addresses any concerns throughout the trial.
What are the potential risks of participating in a clinical trial?
While clinical trials prioritise patient safety, there are inherent risks associated with any medical intervention. These may include side effects from the treatment, discomfort, or inconvenience. Prior to your involvement, the research team will provide comprehensive explanations regarding the potential risks and benefits, aiding you in making a well-informed decision.

IT IS SAID


that if you know your enemies and know yourself, you will not be imperilled in a hundred battles; if you do not know your enemies but do know yourself, you will win one and lose one; if you do not know your enemies nor yourself, you will be imperilled in every single battle.


Sun Tzu, The Art of War