The pharmaceutical industry is undergoing an evolution as new technologies disrupt the industry. The new era of digital health, smart pharma and pharmacovigilance are ushering in advances in key healthcare areas, including medical adherence, how data is captured, how treatment is delivered, how patients can interact with healthcare professionals and an improvement in overall patient engagement.
Pharma companies are having to adapt and innovate to keep pace with the vast changes brought about by digital technology. Advances in cloud technology, mobile communications, big data and AI are disrupting the health sector, resulting in organisations experimenting with a wide range of digital initiatives. But what will be the impact of the latest trends and developments and how this will impact healthcare professionals and patients?
Transforming the approach to drug development
Recruitment of subjects plus their management and monitoring within trials is challenging and several organisations have tried to conduct ‘virtual trials’ with limited success. Social media has been tried as the panacea to recruit. While patients show interest, this does not necessarily translate to participation. Through use of mobile sensors, key biometric data and associated physiology can be tracked. Amusing tales exist of trial subjects exhibiting miraculous changes when, in fact, the sensors were instead attached to their pet dog! Clearly protocol endpoints and regulatory expectations must be addressed in any pre-authorisation trials. Remote monitoring has its place but sponsors must still be able to collect detailed information on clinical endpoints, serious adverse events (SAEs) and events of special interest. The principle investigators and their healthcare professional teams must be provided the digital tools to enable them to capture the key data at required time points or indeed unexpected time points (SAEs). It is in this area that pharmacovigilance, the science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products, is making a difference. Using cloud-based platforms tools such as our Reportum service, which provides a multi-platform solution that enables the standardised capture of adverse event data at source, optimising its quality, gives pharma companies far more accurate data on which to base their assessment and analysis to help produce more refined, effective drugs. Having high-quality data is also important to reap the full benefits of AI that relies on a feed of robust training data. Blending Reportum with AI and Robotic tools affords pharma companies the opportunity to transform their end-to-end drug safety processes today.
While there is no doubt that AI can analyse colossal amounts of data faster than humans to reveal patterns and predictions to enhance disease diagnosis, inform safety profiles, deliver more accurate clinical trials and enhance public health, the insights delivered by AI will only be as good as the data it analyses. Fundamentally, no amount of polishing by AI tools will rectify critical gaps in information that can only be addressed at source.
According to the McKinsey Global Institute, it is estimated that, by applying big data strategies to better inform decision-making, the United States could generate up to $100bn in value annually across the US healthcare sector, in part by ‘building new tools for physicians, consumers, insurers and regulators to meet the promise of more individualised approaches’.
Also worth considering is the effect that regulations, specifically GDPR, will have on these developments. GDPR’s stipulation that patients who grant companies the use of their data can withdraw consent at any time and have it deleted (‘right to erasure’) contradicts regulations governing the integrity of drug development that require all data to be kept on file. While some security can be had from the public health exception in Article 17, which may provide a mechanism for the requirements of good clinical practice and good pharmacovigilance practice to be met while working in the confines of GDPR, there is a real risk that regulations such as GDPR could hinder some of the benefits that big data will have and it’s important that policymakers consider this when implementing the policy.
Medical adherence is being improved
Drug delivery technology has improved significantly in recent years. We are seeing the emergence of smart pharmaceuticals that promise to increase adherence, thus improving the efficacy of medical treatment plans. Factors contributing to poor medication adherence are myriad and include those that are related to patients (for example the lack of health literacy and involvement in choosing a treatment plan), issues relating to the healthcare professional (for example complicated treatment plans, issues relating to communication, failure to inform patients about potential adverse effects of the drugs in question) and those relating to the national healthcare system (for example limited access to care and the lack of health information technology).
Because the reasons for poor medical adherence are so complex, approaches to improve it should be multifaceted. Smart pharmaceuticals, and the added value they bring regarding the improvement of adherence, is one of the areas that is helping to drastically improve adherence. The FDA recently approved a ‘digital pill’. The pill includes an embedded sensor that digitally tracks if patients have ingested it. The makers of the pill hope it will offer a unique benefit for patient groups with typically low adherence, specifically schizophrenics. While this technology is still in its infancy, there is scope for it to be developed further and, eventually, become an important component of treatment for groups with typically low adherence. It must be used alongside diligent medical care so that patients with paranoid symptoms feel reassured rather than have their condition reinforced.
According to a systematic review of 39 studies, published in Clinical Psychology in 2002, a mean rate of medication non-adherence in schizophrenia sufferers is 41%, one of the highest of any particular group. Furthermore, given the serious negative effects of non-adherence among schizophrenia patients, smart pharma could be a key factor driving positive change in ensuring higher levels of adherence among this important group.
More effective tailored treatment plans
Smart pharmaceuticals are also having an impact when it comes to developing tailored treatment plans for patients. Tailor-made treatment plans do require sufficient data to ensure patients are receiving the best possible drugs to treat their illness, ensure greater levels of adherence and improve patient engagement. The McKinsey Global Institute expects that, within five to seven years, a significant proportion of the pharmaceutical portfolio will create value through more than just drugs. This will come partly as a result of many drugs becoming part of a digital ecosystem that constantly monitors a patient’s condition and provides feedback to relevant stakeholders. An effect of this will be that health professionals can begin to target improvements in health outcomes by tailoring therapy to a patient’s individual clinical profile. It also ties into patient empowerment and their ability to be part of their own digital ecosystem, thus closely monitoring adherence with the goal of improving the efficacy of medicines.
A new world of healthcare
Digital health is facilitating an enhanced exchange of information between healthcare providers and patients. Virtual doctors are just one element of the multiple channels that will be used to improve the sector. It is expected that virtual doctors will save national health providers, such as the NHS, more than £20m per year and reduce the time spent on treating minor illnesses, currently costing the NHS around £2bn per year. Other aspects of this omni-channel approach include patient portals, which enable users to access their medical records and communicate with their physicians.
This era of patient empowerment is creating more discerning customers. With the vast array of information available, patients are becoming more inclined to weigh up the merits and downsides of healthcare products, leading to a health competition between pharma companies. We are seeing a move by tech companies such as Apple, IBM and Google into the healthcare sector. These companies are well placed to utilise an array of technologies that can provide insights into the patient’s condition. Such companies, given appropriate permissions and consent are able to collect petabytes of data from patient records, data secured via smart devices and insurance claims to capture valuable data that can help improve the healthcare sector as a whole.
Positive change is occurring across the healthcare sector. New technologies and the growing capabilities of big data are widening access and improving efficacy, thus hugely benefiting patients. Furthermore, digital health, smart pharma and pharmacovigilance are converging and innovative companies are discovering how to implement aspects of all three to provide best-in-class products and services. While this new era might still be in its infancy, the scope for it to completely disrupt and improve the healthcare sector is vast. In our closing thoughts we should take time to remember those that have limited access to technology: the poor, the elderly, those living in locations not served by internet. However for many who suffer from chronic physical disabilities, technology offers an opportunity to transform their lives with voice-activated systems, self-monitoring and ultimately robotics.