Post-Pandemic: An Argument for Protocol Simplicity

The impact of short-term fixes in investigator grants to continue clinical R&D over the duration of the global COVID-19 pandemic will set an unsustainable precedent for sponsors, CROs, sites, and ultimately patients—and should bring a shift toward protocol simplicity.

Protocol complexity is the white whale for many industry experts and has long been trending in the wrong direction. Investigator grants have seen a similar trend upward due to a multitude of factors, but, most importantly, protocol complexity. The two are linked, and unless protocols are simplified, the costs associated with study conduct will continue to increase dramatically over the next few years.

Study protocols were overwrought with unnecessary data points (blood draws, invasive procedures) before the pandemic, and the rush to add flexibility in home health visits or telehealth visits to protocols has not translated to ease of implementation in study start-up or maintenance.

If a pre-COVID visit was bloated with nonessential assessments, how should a sponsor/CRO and site implement that visit and the required flexibility (and complexity) of home health/telehealth visits during this pandemic? How do you justify the necessity of those assessments when CROs and sites have furloughed staff and patients are less likely to adhere to the rigors of study conduct without extensive flexibility?

Protocol complexity translates to R&D cost; sites globally during this pandemic have either had the network support to sustain themselves, pivoted to COVID-19 research exclusively, or made the difficult decision to close. This pandemic will create a longer-term consolidation and reduction of available research sites in any country, adjusting the balance of supply and demand. The U.S. has historically represented about 50% of all of clinical R&D, but as markets emerge and the cost of supporting clinical research reaches exponential levels, I expect sponsors to reallocate spend to countries with more accessible contracted rates.

The exponential jump in clinical R&D costs due to the pandemic will ultimately be passed to the consumer. Sites, CROs, and sponsors have been flexible during the pandemic (and I’ve never seen more collaboration, creativity, and resiliency in this industry), but there is a limit and that required flexibility for current studies will create new standards for site contracting and budgeting postpandemic should protocols retain the complexity at which they are currently written. That flexibility—in the absence of protocol simplicity—results in increased costs (for vendors, sites, solution providers, CROs, and sponsors).

Conversely, the sponsor who chooses to pursue simpler protocols with a reduction of required assessments and added flexibility for continuity and patient convenience will have access to a broader range of sites that would have the ability to implement and support their studies. Protocol simplicity is directly correlated to reduction in overall cost and increased patient adherence, retention, and safety—what does the industry have to lose in pursuing a simpler, more straightforward path?


Until the industry decides to reduce the number of necessary (versus desired) data points for a given interventional study, sponsors, CROs, sites, and ultimately the patients we all serve will bear the resulting costs.