Craig’s List: 5 Predictions for the Clinical Trials Industry in 2024

Forecasts for the new year are a popular theme for posts in the first weeks of January.? Many are coming back refreshed from time off-line, some with fresh optimism and outlook for the new year.? For better or for worse, here are five of my forecasts for those working on clinical trials in 2024.

(1) Sites Question If The Love Is Real

Over the past 2 years there has been a resounding shift in attention from biopharma research sponsors toward the needs of the site.? Benchmarking studies of pharma development operations spending priorities support this perception, including some resources moving from “patient centricity” to “site centricity”.

Much of this has been driven by a staffing crisis at the research site, which has created a shift of supply-and-demand.? With many sites struggling to fill roles, they are in a position to turn studies away; some site leaders in 2023 noted they no longer needed to attend conferences to look for new studies as they were already saturated.

Groups such as ACRP have been shining a spotlight on the urgency of research staffing for years, but the COVID-19 pandemic created a crisis.? As sites are able to normalize staffing levels/gaps during 2023, the state of staffing will move back from “crisis” to “urgent” and supply/demand will rebalance.

Sites still deserve the attention of sponsors, but pharma sponsors tend to gravitate resources and attention to squeaky wheels and fires.? Will sites continue to feel the same degree of attention from pharma, or will these relationships revert back to pre-pandemic “business as usual”? It seems in our industry there is always another fire brewing to divert resources and attention.

(2) Representation Becomes The New Diversity ...Or Risks Political Backlash

Sachin Jain recently posted a prediction that DEI (diversity, equity and inclusion) initiatives in healthcare will face a backlash.? It is a sad observation, but one to take very seriously in clinical research as well.? DEI has become a political hot-button in an election year, and polarization on the topic will only worsen as the year progresses.

There is sound scientific and clinical rationale to ensure that clinical trials are enrolling diverse participants: representation.? The evidence of efficacy and safety that is generated from clinical trials will be used as the basis of treatment decisions for diverse patients, therefore the studies must enroll patients who represent the disease to ensure the data is applicable.? These efforts and investments must outlast the noise and rhetoric that will soon consume headlines and debate stages.

Efforts might be sustained by attempting to educate and inform on the apolitical clinical importance of diversity initiatives, but it will likely prove more feasible in the near-term to embrace language that will be less politically divisive while still achieving the desired outcome.? 2024 may become the year of 'representation'.

(3) The Fall Of Acquisitions

Many of today's tech companies completed large capital raises with high valuations prior during the pandemic.? As markets dropped, these companies have had to go further on existing cash (“stretch their runways”) or attempt to raise bridge rounds (without significantly lowering valuation and irritating existing investors).? Many may have been holding out hope they can “grow into their valuation” with a surge of new business, but that has only been challenged as pharma pipelines -- and spending -- remain stalled.

By this summer, there will be companies at the crossroad and many will become acquisition targets – whether by larger tech and CROs, or to be rolled together with other purchases by private equity.? This may create a Fall 2024 with significant acquisitions.

It is worth mentioning that there have still been opportunities for young early-stage companies to form, albeit at more “pre-pandemic” valuations.? As some existing companies get acquired, this will create a bit more “breathing room” for younger ones to grow and find business opportunities.

For those that do become acquisitions, what will happen next?? We have not seen tremendous success to-date when larger tech, CROs or private equity have made acquisitions in our industry.? In fact, it seems too often that the acquired companies seem to fall off of radars.? Can our industry do better at making acquisitions thrive? Or will acquisitions result in high-potential solutions disappearing from the market?

(4) Where Do Site Networks Go From Here

Private equity investors continue to reward well-performing sites with significant multiples for acquisitions, but PE firms only hold their “rolled-up” companies for a few years.? As the value of these networks continues to skyrocket and the IPO market remains sluggish, where do site networks go next?

In most cases they will likely transition from one PE firm to another, but in some cases we will see the large incumbent providers make big acquisitions.? The big CROs have purchased site networks before (although never at the scale of some of the leaders today), but who else will step forward with deep financial pockets to become owners of the biggest site networks around?? Will the companies holding IRBs further diversify into the areas where they are meant to be ‘independent’? And how will these transactions be beneficial to patients?

(5) Insourcing vs Outsourcing…of Algorithms

Even as pharma (or at least those without a commercialized GLP-1) continue to reduce headcount and cost, many continue to make internal investments in algorithms to power their AI futures.? While tech companies are building solutions meant to support pharma from process automation to LLMs to digital twins, many pharma continue to believe they can build AI solutions that are “fit-for-purpose” with their internal organization and needs.

Still to be determined is how those companies will transition from internally-developed approaches if (or when) those innovative tech companies show superior performance.? Tech companies dedicated to algorithms and AI will pour millions into software development and may draw on far more diverse data across multiple sponsors, while those approaches developed within an individual pharma may see support ebb and flow.?

Dropping an internal approach and transitioning to one from outside is often not a trivial process -- both due to technical integrations but also the sunk cost. Just look how hard it can be to stop an internally developed drug candidate; there's a reason why those in pharma used to say "it's easier to kill the chemist than to kill the chemical."

Bonus: Where For Art Thou DCT?

Since you've made it this far, allow me to add a bonus forecast.

While cynics may be eager to proclaim “the end of DCT” as adoption weakened by the end of 2023, decentralized research methods are far from over.

Sponsors have remained committed to overcoming the challenges of operationalizing and scale – this is the hard and less 'sexy' work that lives in the “trough” of the Gartner Hype Cycle.? But as sponsors remain committed to listening to patients – and will continue to hear about challenges of burden and access – decentralized approaches will remain a critical approach to support access and representation.? Meanwhile the overwhelming signals of support from regulators will continue to remove perceived barriers.?

As companies sort out operations and share evidence through collaborations to understand where DCT approaches are bringing measurable impact, decentralized research will make a very predictable ascension up the “slope of enlightenment”.

The tourists and buzz have left the DCT room; those focused on operations and impact remain committed to getting the models right for patients.