Why You Need a Strong State-of-the-Art (And How to Get There)
If you’re in a clinical research field (or related), you’ve probably heard of a State-of-the-Art. But what is it? And how do you ensure that your clinical evaluation or submission contains a strong one?
What is a State-of-the-Art?
“State of the art” refers to a technology that is the highest quality available of its type. In a clinical evaluation, a “State-of-the-Art” (or SOTA, for short) section encompasses the current state of all available treatment options, and should include information pertaining to the disease the product seeks to cure, alternative treatment options, possible clinical benefit of treatment, and performance and safety metrics of similar devices on the current market. Some organizations may also decide to write a SOTA as part of an FDA submission, in order to establish where their product fits in terms of the current available treatment options.
The literature that encompasses a high-quality SOTA section should be based on rigorous systematic literature searches, and the literature search protocol for these searches should be documented in a detailed fashion. This literature search will be separate from the subject device literature search, and usually should span at least the last 5 years of literature in order to be comprehensive while staying current. In most cases, a supplemental nonsystematic literature search (performed via Google Scholar or similar) may also be completed to fill any potential gaps missed by the systematic search. Google Search tends to be a favorite of experienced medical writers, because while PubMed and Embase allow for systematic searches, Google Search scans full-texts of articles, allowing for closer searches for vital search elements such as manufacturer and product names.
The literature selected from literature searches should itself contain high-quality studies and reviews. Systematic literature searches are preferred, with randomized clinical control trials with adequate follow-up also being acceptable. In cases where materials and material hazards are discussed, bench data obtained from nonclinical studies may also be discussed.
Planning a Quality State-of-the-Art
No matter their area of subject expertise, a properly trained medical writer should be able to write a SOTA about just about anything. Be it a medical device, a new pharmaceutical product, an in vitro device, or even a washing machine, the format for writing a compelling SOTA remains the same:
Overview: A skilled medical writer will introduce their SOTA section by stating what guidance they followed to determine state-of-the-art. In medical devices, this might include specific references to MEDDEV and/or MDCG Guidance. If clinical practice guidelines and recommendations exist for your device group, these are often discussed.
Current knowledge of the medical field: In a standard template, this is often referred to as the Area of Application or Epidemiology subsection. This subsection encompasses the incidence of the disease the product under evaluation ultimately hopes to treat, and any patient-related and/or treatment-related factors that may affect the occurrence of the disease.
Available Treatment Options: Often called an Alternative Treatment subsection, this subjection provides an overview of all the available treatment options that may be pursued as an alternative to the device or product under current evaluation. Possible clinical benefits (and potential risks/disadvantages) of alternative treatment options are often discussed, with the goal being to highlight the gap the current device group fills in the current treatment options.
Standards of Care: This subsection may also be called the Common Specifications subsection, and discusses any clinical standard practice recommendations. This subsection is often based off of recommendations released by various societies, either directly on society websites, or released via peer-reviewed journals.
Similar Devices: Sometimes called the Benchmark Device subsection, similar (or benchmark) devices or products belong to the same generic device group as the current device or product under evaluation. Similar (or benchmark) devices provide information as to just that: metrics on comparative devices that can provide performance and safety benchmarks to later compare to the device or product under evaluation. Comparative devices should be as similar as possible to the device of evaluation, especially in terms of materials, indications.
Discussion and Conclusions: Every good SOTA ends with a summary of what was discussed, and concludes with a firm statement as to whether or not the device or product under evaluation is considered to be state-of-the-art when compared to its device group.
Of note, the SOTA literature search should encompass these elements of a SOTA template, and a quality literature search will produce a quality SOTA section. Unfortunately, that does mean the reverse is also true, which is why a lead medical writer trained in high-quality literature searches is a vital component of producing a quality SOTA.
How the MDR has changed the SOTA
Whether you’re writing a SOTA for an FDA submission, or an MDD clinical evaluation update, many of the conceptual elements of the SOTA discussed herein apply. However, the MDR has changed the process and scope of the SOTA in a number of ways.
In general, the EU MDR has overwhelmingly stressed the importance of clinical data. An EU MDR compliant clinical evaluation needs to discuss the benefit-risk of treatment options, with high-quality literature informing these elements. Alternative treatment options need to be assessed in-depth, as this will also inform the technical documentation. Possible risks and benefits of similar devices must also be obtained via high quality clinical literature.
The EU MDR also provides information about establishing “well established technology” (or “WET”) devices. According to the MDCG-6 Guidance, “Data from similar devices may be also important to establish whether the device under evaluation and similar devices belong to the group of devices considered as “well established technologies” (WET)...Data from similar devices may be used, for example, to demonstrate ubiquity of design, lack of novelty, known safety and performance profile of a generic group of devices, etc.”
Per the EU MDR, manufacturers are now also required to specify and justify the level of clinical evidence necessary to demonstrate conformance in the SOTA section. This recommendation is made in consideration of characteristics of the device or product under evaluation, in conjunction with its intended purpose. The type of evidence (e.g., clinical, PMCF, performance evaluation) should be defined in relation to the SOTA section, and any clinical evidence of the device under evaluation should later demonstrate, by referencing the state of the art section, that the clinical benefit of the device will be achieved and that devices or products under evaluation are safe.
What next?
A quality SOTA starts with a quality literature search, and a quality literature search starts with an experienced medical writer. Check out the related materials from the experienced medical writers at MINOLA SCIENTIFIC to learn more about how you can create a quality SOTA (and subsequent clinical evaluation).
