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.