Diabetic Retinopathy: prevalence and associated risk factors amongst patients diagnosed with diabetes mellitus
September 23, 2024
No Comments
Precision medicine is an emerging approach to treating patients based on their genetic makeup and lifestyle. In 2018, its global market value was $48,554.1 million. Among these, oncology held the highest share. By 2025, this global market is expected to reach
$3.18 trillion with a compound annual growth rate of 10.6%. As per the studies conducted on precision medicine, it has led to improved clinical outcomes and better quality of life for patients. However, this is just the beginning of the precision medicine scenario, a lot is still in the bucket to achieve.
This white paper aims to present the bucket list of precision medicine and give it a human face, from the perspectives of pharmaceutical companies and doctors. This white paper presents the current status of precision medicine in the market and the challenges that are faced during the development and approval of precision medicines, along with the probable solutions. It also contains technological developments made so far in the field of precision medicine and how that is affecting patients.
It is believed that the implementation of precision medicine requires strong communication between manufacturers, regulators, and other involved authorities to make it more flexible in terms of development, approvals, prescriptions, and reimbursements.
Check out this white paper and take a closer look at how precision medicine can revolutionize the healthcare community.
The precision medicine approach is a complete transformation in therapeutic medicine, providing individuals with more targeted, proactive, accurate, and precise treatments. The basis of precision medicine lies in the linkage between a person’s variability in DNA sequence and the cause of a disease. The individualized therapy has brought a revolutionary change to patient care, allowing patients to prevent disease, improve their survival rate, extend their lives, and enhance their quality of life. 1
Globally, its market value was $48,554.1 million in 2018. Among these, oncology held the highest share. This market growth is gaining momentum with time, as it is minutely considering individuals’ variability in genes, lifestyle, and environment. 2 By 2025, the expected global market of precision medicine will reach $3.18 trillion with a compound annual growth rate of 10.6%.
Putting the right patient on the right treatment at the right time is the sole reason for its growth. This strategy has brought revolution as it is away from the current approach ‘one-size-fits-all’ approach, i.e., assuming that all patients with a specific condition have a similar response to a particular drug. 3
There are several precision diagnostic and therapeutic products that are either in clinical trials or pipelines, which add an incremental opportunity to accelerate the market of precision medicine. 5
Precision medicine has a vast potential to provide clinically-and cost-effective treatments. Especially in the case of complex diseases, including cancer and neurological disorders, precision medicine can greatly help when the best therapeutic medicines help only 30-50% of patients. It has proven safety and lessens the financial burden of healthcare systems
Doctors can benefit greatly from this approach to treating a patient because they face frequent barriers, including identical diagnoses of a disease and treatments that generate different outcomes. To overcome these barriers, precision medicine helps in the several ways, a few of which are mentioned below. 6
Early diagnosis and early therapy: While checking the minute details of a patient (such as family health history), doctors can make an early diagnosis of a disease with more specifications, so that an early therapeutic strategy can be built. The newborn screening can also help doctors diagnose and treat the disease early, even before it can develop symptoms or cause any disability in the newborn. This approach is being widely used in the United States to prevent hearing loss and heart defects. 7
Detailed electronic health records: The detailed and better integrated electronic health records of patients can help doctors and clinical researchers’ access medical data more easily. 8 The doctors can use this data for routine medical care in the future too.
Improved ability of doctors: It can also improve the ability of doctors to predict which treatment will work best for a specific patient. Furthermore, doctors will be able to use patients’ molecular genetic information as part of their routine medical care to make their clinical practices more accurate. 9
Clinical trial success rate: As precision medicine eliminates the trial-and-error inefficiencies, it can greatly reduce the cost, time, and failure rate of clinical trials, which will eventually help in bringing about new revolutions and novel discoveries in therapeutic areas. 10
Certainly, the oncology area is dominating the application of precision medicine. However, recently, pharmaceutical companies have shifted their therapeutic focus beyond oncology therapies and moved towards non-oncology areas including neurological diseases, inflammatory diseases, endocrinology (such as diabetes), infectious diseases (such as AIDS and hepatitis), etc. 11
To achieve what precision medicine has promised, shifts on multiple levels (such as data collection, diagnosis, treatment decisions, etc.) are expected to occur. These shifts create challenges, including standardizing the collection of clinical data from volunteers across the country, protecting the privacy of collected data, designing databases for proficient storage of this amount of data, etc.9
As large-scale data are the basis of precision medicine, therefore, synthetic and multi-level studies are required to understand the phenomena of genes at all levels. As mentioned above, standardization of this data is highly required, but in the case of data from omics studies, we get data of poor and low reliability. Clearly, there is an urgent requirement of quality control standards for omics data.
Solution: While visiting a doctor with a problem, a huge amount of patient data is noted, including the demographic data, physiological data, laboratory data, genomic data, and other questionnaire information. A publication in the New England Journal of Medicine reported a solution to effectively and accurately storing such large data. This involves the implementation of ontologies. Ontologies are like vocabularies, which are terms used for representation, formal naming, definition of the categories, and properties and relationships between them. Ontologies can effectively provide logical consistency across huge numbers of concepts and terms. When combined with electronic health records, ontologies can improve the classification of patients as well as their diagnostic and therapeutic insights.13,14 Besides this, the patient data need to be checked at a specified interval and correlated with the concerned patients regularly.
The motive of precision medicine is to provide individualized treatment to patients based on their biological responses. However, it is very well known from the clinical trials that the effect of a medicine on the patient is not solely dependent on the genetic make-up of that person but also on the person’s living habits, environment, growth experiences, cultural background, and other individualized factors. This clearly indicates thatthe provision of precision medicine requires a greater degree of personalization. To administer precision medicine to a patient, it is important to have information about the lifestyle of the patient, which is a significant challenge for doctors to extract accurately from patients. 12,15
Solution: By establishing a strong relationship between a doctor and a patient, the doctor is able to obtain quality information from the patient to enhance diagnosis. This results in better, more accurate treatment. 16 In order to build this relationship, doctors have a major role to play. The recommended techniques are:
The involvement of regulatory bodies in any clinical study revolves mostly around the protection of participants. So, in the case of testing precision medicine, patient protection and encouragement for innovation are also regulatory challenges.18 However, no clear regulatory guidelines are there for testing precision medicines which might be because this technology is still in process, and the regulations are underway. 19
Additionally, the uncertainty about the clinical trial process for testing precision medicine creates uncertainty about regulatory approval. Along with the high cost associated with the regulatory approval process, the failure to gain approval means no recovered cost. The developers of precision medicineshow interest to have guidance on how best to design a successful clinical trialfor testing precision medicine. Without proper guidance, many growing companies are reluctant to make their investment due to an increase in the uncertainty of regulatory approval. 20
Solution: Many authors have recommended solutions to regulatory challenges. These include improving clinical trial designs in such a way that precision medicines could pass through the regulatory approval stage, reduce cost, not rely on animal models, strengthen post-marketing study requirements, and foster closer and clearer working communications between manufacturers, regulators, and reimbursement authorities earlier in the drug development process, which can help the manufacturers understand the kind of evidence required for reimbursement decisions.
The new technologies are highly required to generate new data, support the advent of precision medicine, and tackle the challenges faced during their development. Several technologies have been proposed for fulfilling such requirements, which include artificial intelligence, health applications, and biomarkers. 21, 22
The use of algorithms for artificial intelligence and machine learning to help in clinical decision- making has increased recently. These algorithms use a large number of variables, including genetic information, demographic characteristics, social information, and the electronic health records of patients. Artificial intelligence software made from these algorithms, which contain such vast variables, provides doctors and patients with predictions on expected diagnoses and precision medicine choices. The great benefit of this technology is that these algorithms regularly update as new information on patients is added to provide more feasible treatment options.
Artificial intelligence-based technology, such as health apps in phones or watches, receives and processes patient data, provides disease management advice, and records physiological data such as blood pressure, heart rate, blood glucose levels, and so on. Such health apps are increasing significantly as precision medicine technology advances. As per the predictions of digital health experts, potential apps in future would analyze social or lifestyle determinants of health to stratify patients.
A wearable-based mobile health app was assessed in a clinical study involving gastric cancer patients for monitoring postoperative physical activity. The promising results were obtained from the wearable device connected with the mHealth app. The app provided seamless tracking of the recovery of patients and turned subjective physical activity into an objective one. 24
Biomarkers have a technological role in the development of precision medicines, as their development and applications can be used for both preclinical and clinical stages. It can improve human health and reduce healthcare costs as well. Moreover, biomarkers can accelerate the path to precision diagnostics, which can ultimately lead to early and accurate treatment. 25
Precision medicine is clearly reshaping the biomedical community, especially in terms of therapeutics and research. This technique has enormous potential to break the widely held notion that “one drug fits all.” Although the drug manufacturers and researchers face numerous challenges in its development, such as standardizing the collection of clinical data from volunteers across the country, protecting the privacy of collected data, designing databases for efficient storage of this amount of data, regulatory barriers, etc., solutions to all these challenges emerge simultaneously, as we have already discussed above. Another bright side of precision medicine is its developing technologies, which benefits both manufacturers and patients. Besides, this technology is expected to expand significantly over the next decade, which will eventually change the way treatments are offered and evaluated. Currently, a strong regulatory framework is all that is needed in this field. It is important that healthcare systems around the world adjust their evaluating methods and processes and provide clear regulatory guidelines so that precision medicine continues to benefit patients.
:~:text=Better%20understanding%20of%20the%20underlying,access%20medical%2 0data%20more%20easily.
https://clarkstonconsulting.com/insights/personalized-medicine-quality-regulatory/
Reviewer: Priyanka
Copyright © 2025 All Rights Reserved