by a thorough examination of their medical history and non-invasive health checks. The drug toxicity is a measure of how much of the drug can be taken without affecting the person’s control and capacity. Phase 2 then focuses on the benefits of the drug, using several hundred volunteers. Once these have been recorded and finalised based on concordances in findings of the whole trial group, phase 3 starts. This is the most important stage as the researchers find definitive answers to the drug’s accuracy, efficacy and ethics using thousands of volunteers. This larger scale trial is run as a randomised control trial, where a control group receives a placebo whilst another group receives the real drug. To ensure minimal bias, often the researchers or people administrating the drugs (nurses) do not know which of the two they are giving. This can take a very long time, as firstly volunteers need to be given the drug then the effects of the drugs needs to be thoroughly assessed. Lastly, phase 4 comes into action. This is a final safety measure and also observes long term effects using a wide population size. So for a clinical trial to be run, these four things must be outlines: Population (the target demography, so for HIV trials the population was 16 to 26 year old females), intervention (the treatment drug being tested), comparison (a form of placebo), outcomes (the changes or potential harm from this).
THE RISE OF EVIDENCEBASED MEDICINE: A MEDICAL REVOLUTION Alina Nishat (OHS) Changes in healthcare have varied in how they have impacted the wider world. For example, the discovery of antibiotics such as penicillin led to a sudden change in the treatment for bacterial infections. On the other hand, the ‘sanitary revolution’ was more subtle but reduced the spread of disease greatly in 19th century Europe. The advancement of medical technology and better understanding of mechanisms of illnesses have improved diagnosis and treatment of a plethora of illnesses. However, whilst treatments have been progressing, often the ethics and reliability of such treatments and the details of their effects are not clear; this can sometimes make patients feel disadvantaged and in the dark, a typical effect of paternalistic medicine. The rise of evidence-based medicine, however, has arguably eased the transition of medical care into patient-centred care.
EBM also requires ‘clinical expertise’, which is judgement and analysis from experienced clinicians on the clinical evidence acquired. An understanding of patient values means that the medical pillars of autonomy, non-maleficence, beneficence and justice is carried through. Specifically, an effort is being made to understand and identify what the patient is feeling and what they want to offer individual services.
Evidence Based Medicine (EBM) is the practice of trialling and testing drugs and treatments for patients, combining three key factors: the best research evidence available, clinical expertise and patient values[2]. Often, one of the components that are now used in EBM were missed before medical advice or drugs were issued to the public, which led to devastating consequences. One such incidence was the Thalidomide Tragedy of the late 1950s, where the impact of the ‘Thalidomide’ drug for preventing nausea in pregnant women was life-changing for their babies, who were revealed after birth to have major developmental problems and birth defects. This received global attention and highlighted the importance of stringent clinical trial processes, as whole generations of babies were adversely affected. EBM can also be used to achieve the fine balance between what clinicians think is the right thing to do and what the patient actually wants, backed up by scientific evidence. For example, a doctor may give medication that lowers blood pressure, but the patient is actually feeling faint and having bad side-effects; this cannot be ignored, so the healthcare provider must address it and offer a different medication.
This last point, when integrated well with clinical expertise and the best research available, has helped further the transition from a paternalistic approach to medicine, or more consumer-based, to today’s precise, personalised patient centred care. This is because as more evidence is collected, certain drugs and treatments are accepted or rejected based on intricacies on how they work on different people. The nature of EBM includes large randomised trials with a representative sample population, so this takes into account patients before any economic benefits or the physician’s own, and typically generalised, views. EBM uses the patient’s values to decide how the evidence is applied in that specific scenario, whereas paternalistic medicine was notorious for the assumed upper hand doctors had in making decisions for their patients. Patient autonomy was not strictly followed or understood, as their personal views and experiences were typically simplified and generalised. In fact, the paternalistic approach to medicine increased mistrust in physicians, resulting in a dysfunctional and harmful patient-doctor relationship which led to lower patient adherence[3] (the degree to which a patient correctly follows medical advice).
The best research available refers to the results of trialling a drug, and the clinical trial process has four stages. Firstly, the drug undergoes animal testing to observe potential extreme side-effects. Next, Phase 1 consists of selecting a small sample of, for example 80, healthy volunteers to trial the drug for toxicity. The health of these volunteers is measured before-hand 27
