Barriers to the Integration of Digital Health in Pharmaceutical R&D: Conservatism and Evidence Gaps

There is much discussion today on how to integrate new internet healthcare technologies and models into the field of drug development. While optimistic views abound, so do pessimistic ones. As the saying goes, opportunities and challenges coexist. On the English website of Forbes, David Shaywitz, a columnist in this field, recently published an article expressing his views. VCBeat has compiled and translated the main content of the article as follows.

Over the past several years, I have been striving to demonstrate that digitalization can bring about a significant breakthrough in drug research and development. The reasons are as follows.

First, this technology enables us to gain a more profound understanding of patients’ lived experiences while suffering from illness, and reveals the unique characteristics of novel therapies. It also identifies the specific areas where new drugs need to exert their therapeutic effects.

Secondly, digital therapeutics can display richer readings regarding the pathological characteristics of a specific disease and, through their unique configurable basic recognition mechanisms, reveal the precise category to which the disease belongs. Leveraging this capability, digital health finds utility in many areas, such as improving patient adherence to medical advice, population-level analysis, and assisting in clinical diagnosis.

Yes, pharmaceutical companies have begun to gradually embrace internet healthcare, and the public has started to praise and hail it as a victory. However, I do not share this view; at least from an R&D perspective, things are not quite as they seem. In my opinion, internet healthcare largely remains in a stage of “innovation requiring practical validation,” rather than being an industry with “significant market demand” as the public perceives it (such as pharmacology). Pharmaceutical R&D departments have only just begun to dip their toes into digital health (and they are already pleased with themselves for their boldness at this early stage). Moreover, what will truly spark their interest in internet healthcare is certainly not what I would describe as “pig committed.”

During my conversations with heads of R&D departments at several pharmaceutical companies, two challenges facing this field emerged.

Conservatism Becomes the Biggest Obstacle

The first challenge is that current pharmaceutical companies are extremely conservative. Within these organizations, entrenched industry norms are difficult to break. Crucially, pharmaceutical companies often shift the blame for their resistance to change onto others, frequently citing excuses such as “overly stringent management” or “we want to change, but the Food and Drug Administration (FDA) would not support it.”

I have a vivid example to illustrate this point, citing Dr. Ethan Basch’s commentary in The New England Journal of Medicine. In his commentary, Basch asserts that if pharmaceutical companies were to gain deeper insights into medications highly favored by cancer patients, such understanding would incentivize them to develop and market more of these patient-preferred drugs, even if those drugs do not reduce cancer mortality rates. However, Basch observed that an emerging class of second-generation anticancer drugs met this criterion yet was ruthlessly abandoned by pharmaceutical companies. Compared with first-generation agents, these second-generation anticancer drugs exhibited lower tolerability. Merely because they failed to significantly reduce cancer mortality, the developing institutions faced substantial financial liabilities. Meanwhile, pharmaceutical companies turned a blind eye to patients’ clear preference for these drugs, had they been given the opportunity to express it.

I believe that drug development is unlikely to be disrupted by patient-centric internet healthcare technologies. Although the aforementioned secondary example does not yet fully support my argument, it does accurately reflect the prevailing mindset of current drug R&D professionals.

Another example that reveals the conservative mindset of current pharmaceutical companies is their anxiety over identifying new trial endpoints—whether to succumb to reality or remain patient-centric. Although some pharmaceutical companies have realized that existing disease endpoints may not necessarily correlate with patients’ actual conditions, it still requires considerable effort to persuade them to seek new endpoints that better reflect patient status. Moreover, no one yet knows how to gain regulatory approval for such novel endpoints. As a line from Pixar’s 2007 animated film Ratatouille goes, “Newcomers need friends,” which aptly describes the pharmaceutical industry’s attitude toward endpoints.

If you want to truly grasp how conservative pharmaceutical companies are, consider this scenario. Pharmaceutical companies view the transition from manual data entry to electronic data capture as a regression in traditional clinical research. A surgeon I know once told me that in his specialty, pharmaceutical companies refuse to adopt novel endpoints; they even continue to use outdated manual methods for recording symptoms. Their rationale is that all existing drug studies have relied on manual data collection and established endpoints. Since they perceive that neither of these elements has embraced digitalization, they consequently resist transitioning to digital approaches.

New Approaches Still Need to Further Prove Themselves

The second challenge facing internet healthcare technology is that pharmaceutical companies believe there is scant evidence demonstrating the unique efficacy of digital health solutions, and such evidence lacks the rigor valued in clinical research. This criticism has been regarded by some authoritative scientists as conservative, stagnant, and resistant to progress, with these scientists arguing that pharmaceutical companies lack innovative spirit.

These scientists’ ideas may have some merit, but the reality is different. Looking back at the history of medical development, it is replete with technologies and therapies that appeared promising but ultimately yielded limited benefits. Examples include the use of antiarrhythmic drugs to prevent sudden cardiac death after a heart attack, or the application of stem cell transplantation in the treatment of breast cancer.

It is necessary to find robust evidence to demonstrate the efficacy of digital health, but the challenges along this path may be greater than we imagine. Our experience with biomarker technology serves as a cautionary tale. Initially, there was widespread public optimism that developing widely applicable, easily accessible molecular-level identifiers would significantly aid drug development, as such molecular identifiers could reveal the mechanisms of action of existing therapies. However, extensive practice has demonstrated that developing reliable biomarkers is more difficult and complex than most people anticipated (a fact that some still fail to fully appreciate). In this regard, I recommend listeners tune into an interview with Anna Baker on Mendelspod, which offers a genuine sense of the complexity involved in biomarker development. In my view, our digital health technologies (or digital biomarker technologies) lag behind molecular biomarker technologies by approximately a decade. Hopefully, the hard-won lessons from the development of molecular biomarkers—including the necessity for rigorous data collection and pragmatic utility analysis—will accelerate our adoption of digital health technologies.

Compared with other therapies, one of the most obvious advantages of internet healthcare technology is that it is more closely integrated into daily life than biomarker technology. We are all familiar with wearable technology. Many of us constantly monitor ourselves for signs of illness and expect our physicians to do the same. Many hospitals are also seeking ways to collaborate with wearable devices. Furthermore, many academic clinicians are beginning to leverage their expertise to carefully evaluate existing technologies and develop new therapeutic approaches.

To return to the main topic, I am pleased to see that internet healthcare technologies are gradually being accepted in clinical drug development, which will bring many benefits to patients. Indeed, the revolution is not yet complete, but we are not far from it.

(Original Author: David Shaywitz; Compiled by Zhou Changling; Edited by Luo Xiaosou)