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An introduction to Personalised Medicine

Just because two individuals are diagnosed with the same disease, it does not mean they should be treated in the same way, a concept known as personalised medicine. Personalised medicine, also referred to as precision medicine, is an emerging approach that uses an individual’s biologic profile (e.g., genetic, protein) to guide decision-making with regards to disease treatment, diagnosis, and prevention. 

Personalised medicine is set to transform the healthcare system by tailoring treatments to each individual rather than following the current “one-drug fits all” conventional therapy approach. Many patients may share a diagnosis, but the nature of their disease may differ.  By exploring the unique disease characteristics specific to each individual, personalised medicine aims to design tailored treatments that will ensure more successful outcomes with fewer side effects

The field of personalised medicine is rapidly expanding with a growing number of targeted treatments reaching the market. However, development of more advanced technologies is needed to meet time and cost challenges in implementing more targeted therapies as part of clinical practice. Nonetheless, rapid progress in this field points towards a time when precision medicine will be part of routine medical care to target the right treatments to the right patients at the right time. 

A biomarker, or biological marker, is a measurable indicator of a biological state or condition. Biomarkers can have molecular, histologic, radiographic, or physiological characteristics. Examples of biomarkers include everything from blood pressure and heart rate to MRI findings to complex histologic and genetic tests in blood, other body fluids, or tissues that serves as an indicator of a particular physiological state. A biomarker’s detection may be a sign of a normal or abnormal process, or of a condition or disease. There are different types of biomarkers including diagnostic which determine the presence and type of disease, prognostic which give information on the patient’s overall disease outcome with or without standard treatment, or predictive which help to identify which treatment the patient is most likely to respond to or benefit from.

Biomarkers are becoming increasingly important in medicine and especially within the realms of personalised medicine. They are crucial for predicting prognosis and treatment responses to therapies that a patient may be receiving in the future, meaning that the biomarker may affect the outcome of the treatment. Thus, biomarkers are crucial for selection of suitable patients for treatment with certain drugs (e.g., targeted therapies), enabling personalized medicine in that the patients will receive the right treatment fitting their profile at the right dose at the right time.

Emerging treatments are novel therapeutic approaches showing promising results from early research findings or clinical trials but have not been established as a standard of care for treating patients. A standard of care is a guideline specifying the appropriate treatment to be administered to a patient with a certain condition and is widely used and well regarded by healthcare professionals. Appropriate treatments can range from drug administration to surgical intervention or the use of a medical device depending on the disease type.

Recent technological advancements and scientific discoveries are driving the exploration of emerging diagnostic and treatment options. Sequencing technologies allow for rapid characterization of a patient’s complete DNA enabling scientists and healthcare professionals to obtain a specific disease profile for that patient. This specific patient disease profile gives greater insight into not only the mechanisms driving the disease but also allows for the delivery of treatment approaches most likely to benefit that patient (targeted therapy).  

The field of personalised medicine aims to deliver a specific treatment to a patient with a specific profile at the right dose and the right time. Emerging treatment options are harnessing these sequencing technologies to investigate the application of novel therapeutic approaches in a personalised manner compared to existing conventional treatments.  

Clinical trials differ from “pre-clinical” studies in that they involve human subjects. Often trials test new drugs, new combinations of drugs, new medical devices, or surgical methods. They can also be designed to find new ways to use existing treatments or how to change behaviours to improve health quality of life. 

Clinical trials help discover whether new treatments, prevention, and behavioural approaches are safe and effective in human volunteers. The first patients to receive a break-through treatment are the participants in trials where these treatments are tested. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future. 

In the United States, clinical trials are a legally required pathway for a new drug, diagnostic test, or medical device. That is, only those products that have received a license can be legally sold for the purpose of treating human disease. There are similar laws in this regard in most nations of the world. Agencies such as the FDA in the United States or the EMA in the European Union decide whether a medical product receives a license to be used.  

For a product (i.e., drug, test, device, etc.) to be approved by the FDA or EMA, it must move through three phases of trials (phase 1 to 3). There are usually several distinct trials of a product within each trial phase. Each trial is a study with in its own predefined experimental design. The institutions sponsoring trials will decide as these progress whether to continue with the product or to withdraw it from the process. If all three trial phases are completed to the satisfaction of the sponsor, the results of each trial (along with all supporting preclinical data) will be submitted to the agency to be evaluated. 

Phase 1: These are generally trials of a product (most often a drug candidate) previously untested in humans. There are usually only a couple of trials planned per new product, and only a small number of participants are recruited per trial (no absolute rule but usually around 20 to 30). They are designed to document side-effects (establish safety), discover optimum dosing and may also measure drug excretion and metabolism.  

Phase 1/2: Trials may be designed to move patients through a process depending on results. These may in effect bridge phases 1 and 2.  

Phase 2: Effectiveness is the outcome measure under focus in phase 2 trials. At this level, the drug being tested is usually compared to other therapeutic approaches. Phase 2 trials usually recruit upward of 100 participants.  

Phase 3: Once phase 1 and 2 trials have established safety and efficacy to the satisfaction of trial sponsors, they may decide to continue with the new drug to phase 3. At this level the aim is to see if what was learned in phases 1 and 2 holds in a larger group (often more than 1000 participants).   

Phase 4: Yes, there are “aftermarket” studies of drugs and other medical products that are already licensed for sale by the FDA or relevant agency. Here the point may be to continue to gather efficacy and safety data from the regular use of the drug (and in some cases other products). These studies can open up new insight into how the therapy might be best used. In some rare cases, phase 4 may discover safety or efficacy concerns that cause approval to be withdrawn.  

Phase not applicable: These are trials without FDA-defined phases, including trials of devices or behavioural interventions that are not seeking approval for marketing. There are a large number of trials that fall into this category. Some of these trials test aspects of treatments such as how instructions are communicated or how a given procedure performs under different circumstances, etc. 

Trial eligibility: Sponsors of clinical trials absolutely want participants, but that doesn't mean each case fits their need. Trial descriptions list specific criteria for the inclusion or exclusion of participants. The guiding principle to these criteria is that a participant should at least have some possibility of successful treatment with the therapy being tested.  

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