Patient care, at the speed (and scale) of science

By Dr. Gautam Gulati, Innovator-in-Residence and Curator of Klick Author Series, Klick Health

The urgency of a worldwide pandemic and the fluidity of modern communications platforms have led clinicians to new, crowdsourced research models that deliver radical increases in speed to care.

After the pandemic, how can we leverage the current change in mindsets toward these new research models and leverage the resultant behaviors?

• Can physicians make evidence-based decisions in real time and still do no harm, or do we need traditional long-term analysis in every case?
• Can real-time tools accelerate and amplify the current clinical guideline development process?
• Can we collect real-time contextual and demographic-specific inputs to inform all of our medical and marketing activities to have a greater impact on patient outcomes?

If there’s one thing we’ve learned from this pandemic, it’s that science does not wait for anyone. Given the urgency of containment and timely intervention measures for the SARS CoV-2 virus, many providers are not letting good enough stand in the way of perfection. They’re teaching and learning from each other in real time, and making critical clinical decisions based on credentialed and verified peer recommendations. This new decision-making approach has put into question the requirement for universal consensus on triage protocol and treatment guidelines that can delay the right action in a moment of need.

During this time of the pandemic, real-time peer review is happening in droves. It’s happening in private backdoor conversations encrypted on Slack, WhatsApp, and the like. Doctors from China and Italy are sharing rapid investigator studies and commentary on prevention protocols, treatment guidelines, and even therapeutic interventions that can then be applied to local cases here in North America.

Real-time collaboration has been made possible today through cloud computing. Now anyone can view, comment, and edit shared files, which function most like wiki pages with real-time collaboration for doctors. Peers are now able to support, reject, question, challenge, or confirm peer recommendations. Peers are invited by referral to help ensure medical credibility and to validate expertise. Each peer is incentivized to then offer their expertise for the greater good of the community. Once a consensus is rapidly achieved, such guidelines are then “spun out” and shared with the medical community at large.

I’ve seen real-time protocols developed and released by health professionals on the front lines at Stanford, Brigham Women’s Hospital, and several others. I’ve seen physicians challenge the use of unproven, media-hyped drug combinations such as hydroxychloroquine and azithromycin. I’ve seen sub-protocols being developed for specific use cases, such as for patients who are immunocompromised, for patients that experience a cytokine storm, or for a better understanding of the trajectory of multi-organ involvement as the disease takes its course. I’ve even seen the sharing of how-to-hack protocols for converting single patient ventilators into dual-use, and instructions of how to 3D-print PPE and respiratory devices.

We’ve observed that the recent loosening of restrictions by the FDA of Emergency Use Authorizations for select medications and diagnostics has forced some health providers to take matters into their own hands. Knowing an existing medication may have possible benefits in select patients for compassionate use situations, physicians do not want to rob the very sick patients of a potential lifeline.

When the pandemic eventually subsides, we will be left with a choice: will we embrace these changes and incorporate rapid, real-time peer reviews, or will we let them fizzle out and revert back to the status quo?

While such practices may not be suited for those decisions that can afford the luxury of time, having such tools available at hand can prove to be lifesaving in cases where urgent and underdeveloped recommendations are desperately needed.

Perhaps we will explore the immediate applicability for select use cases to accelerate areas of science and research that can either benefit from accelerated peer reviews and/or benefit from time-sensitive conditions where immediate lives are on the line.

Action plan for life science leaders

Let’s consider the possible future that leverages real-time collaboration tools for peer reviews and collaborations. Here are some ways to take advantage of these new ways of working going forward.

1. Determine which conditions and medications could be better suited for rapid peer review to speed up their development and approvals:

• • Consider how this approach could speed up development of orphan or precision-based medications.
  • Consider how rapid peer review could help assist central committees for FDA approvals and the like.
  • Create a collaborative model with advocacy groups and the CDC/NIH/FDA to establish a data-driven approach, like the NICE-style metrics, that can be used to guide specific recommendations by condition. In this collaborative model, past requirements can be loosened in the pursuit of getting therapeutics and diagnostics in market faster.

2. Real-time physician input:

• • Using real-time messaging platforms, create closed self-run/regulated physician virtual committees that answer key questions that help inform approaches, guidelines, etc.
    • The outputs from the committee, which are based in real-world experiences, could be used to speed up medical and/or marcom activities.                                                                                                        

3. Real-world, real-time patient segment inputs:

• • Gain real-world, real-time understanding of physicians’ experiences at any time, not just once a year when a segmentation may be created.
    • Gain a deeper and quicker understanding of how to optimize treatment across various patient segments and understand patient segments that you may not have known existed.

4. Incorporate agile methodologies:

• • In an era of accelerated digital transformation, parse out areas of digital development for applying agile methodologies to patient and HCP solutions with rapid turn-around (days to weeks) instead of applying traditional waterfall methodologies (months to years).
  • Reconfigure and incentivize internal product teams to work in agile environments for quicker turnarounds and rapid feedback loops.

For more details on how to implement these steps, please explore Life (Sciences) After Covid-19, to read the full article and find a collection of Klick Health perspectives designed to inform and inspire the life sciences community for the changes, challenges, and opportunities anticipated as a result of the global health crisis.