Clinical Evidence Must be at the Heart of DTx Solutions. Here’s Why.
Sidekick Health is committed to demonstrating rigorous clinical evidence for all our digital therapeutic (DTx) solutions. We understand the importance of ensuring that health interventions are safe and effective for patients.
Not all clinical evidence is created equal, however. This article breaks down the essential components of what makes a successful – and clinically reliable – digital therapeutic.
What is Clinical Evidence?
Clinical evidence is a collection of information and data produced through research in systematic scientific trials to demonstrate a medication or therapeutic’s medical effectiveness, potency, and safety in the treatment of a patient for a particular disease.
As with all treatments, whether they are pharmacological, physical, or digital, the clinical evidence for a therapeutic must be proven before it can be deployed to treat patients.
Good clinical evidence will involve the highest standard of scientific research and evaluation.
Clinical evidence exists not just to satisfy medical regulatory requirements to ensure that a treatment will not harm a patient, produce disproportionate side effects, or be ineffective, but it is also the basis of good scientific research:
worthy medical advancements are always based on necessity (a true and unmet medical need),
ethicality (satisfying the ‘four pillars’ of medical beneficence, non-maleficence, autonomy, and justice), and
accountability (ensuring that research and treatment is always carried out by those with appropriate qualifications and with the high standards for integrity that healthcare rightly demands).
Hierarchy of Evidence
Different types of evidence serve different purposes, but generally speaking, the best forms of clinical evidence are towards the top of the diagram below:
In terms of prospective studies to examine a new intervention, Randomized Controlled Trials (RCTs) are considered to be the ‘gold standard’ for producing reliable data that reduces bias. For Sidekick Health, RCTs are always a part of the long-term evaluation pathway when we design a new digital therapeutic solution.
Are DTx Bound by Clinical Evidence Requirements?
The Digital Therapeutics Alliance (DTA), a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics, provide the following official definition of DTx:
Digital therapeutics deliver evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.
The DTA go on to establish foundational principles that an intervention must abide by in order to claim use of the term ‘digital therapeutic’, including:
Publish trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals.
Make claims appropriate to clinical evaluation and regulatory status.
Collect, analyze, and apply real-world evidence and/or product performance data.
These specifications ensure that DTx are patient-centric, scientifically sound solutions that can provide a number of clinical benefits to payers, providers, and pharma alike.
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DTx are evidence-based treatments delivered via digital modalities. They can be used alone or in combination with other therapies to prevent, treat, or manage a wide range of medical conditions. However, with the boom of wellness apps on the general user market, the challenge remains to differentiate a DTx as a specific treatment that targets a particular disease or set of diseases in a clinically-effective way. Clinical evidence is what separates a DTx from a wellness app.
In a similar way, pharmacological treatments also face this challenge. Both medicines and homeopathic remedies can look alike. At an initial glance they may look indistinguishable, packaged in familiar tablet blister packs or bottles. Fortunately, there are strict regulations to ensure a medically effective and safe drug can be differentiated from an un-tested herbal supplement, ensuring patient safety. These regulations and requirements underpin the forming of gold-standard clinical evidence to demonstrate the clinical efficacy and safety of a drug, and the same standards apply to a DTx.
Instead, DTx must be able to demonstrate they have an actively positive, safe, and clinically-relevant effect on the patient. This evidence not only provides the patient with a treatment that is effective, but it also allows payers and physicians to identify with confidence those DTx which are going to be of most benefit to their patients.
Clinical evidence is not just limited to controlled clinical trials. Extremely valuable information can also be gleaned from real-world data (RWD) – that is, the data produced in real-life settings in the form of electronic health records, patient surveys, and health insurance records. This is a crucial stage in the evaluation process of a therapeutic as it allows for assessment of the intervention amongst the general population, encompassing heterogenous patient characteristics that may not have been fully represented in clinical trial cohorts.
Real-world evidence (RWE) can be derived from the analysis of RWD, which can then be used to demonstrate the efficacy of a treatment to all stakeholders, from the patient being treated to the payer that is reimbursing the treatment.
How can a DTx Solution Provide Clinical Value?
The RWD generated by DTx gives a wealth of long-term information about treatment effectiveness that can be analyzed and fed directly back into the research and development (R&D) process for pharma companies. This is particularly useful in assessing the impact of the DTx on population subgroups, which may not have been feasible during clinical trials.
DTx also have the ability to improve medication adherence through program design, ensuring patients receive reminders and tracking abilities for taking their medicine regularly and on time. By improving treatment compliance, pharma companies can ensure their products are being used to their full effect, and healthcare providers can be better equipped to tailor treatment plans for their patients in the knowledge that the medication was taken as intended.
By their digital nature, DTx support rapid updates to software. Some also have AI functionality that can use specialized algorithms to adjust to the individual user’s habits and preferences. These features enable the DTx intervention to not only be personalized, but also swiftly aligned with the latest changes to best-practice clinical care guidelines.
Where it may take many years to develop a new cancer drug that doesn’t have such severe side effects, a DTx solution can be updated quickly to adapt to a patient’s needs.
Additionally, by making patient-reported outcomes (PROs) a focus of the platform, DTx can help drive a paradigm shift towards value-based care. PROs typically cover metrics such as quality of life measures, patient satisfaction, and symptoms from comorbidities. By actively including these metrics in the treatment equation rather than taking a traditional, siloed approach in treating a disease in isolation, the patient is treated holistically. Holistic, patient-centric care has been established as an effective approach to improving patient outcomes.
DTx offer cost-effective treatment due to their increased scalability compared to traditional treatment options such as drugs or face-to-face appointments, and also due to reduced patient dependency on in-person healthcare services.
By their digital nature, DTx are inherently accessible too. Over 85% of Americans currently own a smartphone and projections estimate over 92% will have one by 2025, and this is the most common platform for a DTx to be offered on. Therefore, DTx can support patients to receive care where they may have been unable to do so for physical or financial reasons prior.
With relatively lower capital investment, and typically lower R&D costs than those associated with new drug development, DTx can also deliver value beyond the pill for pharma.
Clinical evidence is at the heart of DTx solutions and is a priority for Sidekick Health. The research and development process of a DTx is based upon internationally recognized standards of clinical quality, efficacy and safety, as it would be in any drug development process. DTx have the potential to be as powerful as traditional medications in treating diseases, and so it is crucial that there is strong evidence to support the clinical benefit to the patient as well as the economic benefit to the developer and payer.