The Covid-19 pandemic has brought about a seismic shift in the clinical trial industry, altering the foundations of clinical trial design and management. As the industry adjusts to a new normal, the changing landscape has caused trial sponsors and contract research organisations (CROs) to rethink how they collaborate.
New operational challenges—from diversifying patient recruitment to managing virtual visits—have left many pharma companies reassessing how they work with CROs across their portfolio. Experts say the traditional model of relying on a small number of CROs has fallen out of favor as sponsors prioritise flexibility and customised outsourcing models.
Pharma companies are particularly looking to collaborate with a wider range of both specialty and full-service organisations, or even to reduce overall CRO reliance.
Meanwhile, CROs have also changed their offerings to meet evolving sponsor demands. Experts say open data-sharing models and personalised medicine are quickly becoming industry standards. And while the surge in decentralised clinical trials could witness a slight decline in uptake, a broader focus on adaptive trial design remains here to stay.
Before the Covid-19 pandemic, most pharma companies had broad, transactional relationships with CROs across their whole portfolio, explains Kenneth Getz, who researches clinical trial management practices at Tufts University.
Now, more sponsors are pursuing “hybridised approaches” where they juggle multiple types of CRO collaborations simultaneously. This could mean engaging with a handful of boutique or specialty CROs for one trial, while using a traditional full-service CRO for another.
Meanwhile, some small and mid-sized pharma companies are looking to add flexibility by reducing their comprehensive reliance on CRO support. “Bringing a wide range of clinical operation functions in-house, rather than out-sourcing them to a CRO, can achieve significant efficiencies across the clinical trial process,” explains VistaGen Therapeutics CEO Shawn Singh. VistaGen has elected to perform more clinical trial management in-house for a Phase III program in social anxiety disorder after pivoting the primary endpoint from a previous study.
Nevertheless, Singh says there are still key functions that warrant collaboration with CROs provided there is in-house oversight from the sponsor. These include data management, regulatory submissions, and serious adverse event reporting that can leverage existing CRO operating procedures and processes.
Above all, Getz says the pandemic caused pharma companies to realise the importance of agile development. The recent uptick in patient recruitment delays, drug supply shortages, and adaptive study designs have highlighted the need for more trial flexibility. “Going forward, pharma companies will be even faster to pivot and change how they approach the execution of their trials to accommodate curveballs that take place when the trial is already underway,” he notes.
Data drives innovation
Looking ahead, experts say the CRO and sponsor relationship will be marked by more widespread data-sharing. Rather than each party controlling siloed datasets, open collaborative models across stakeholders are quickly becoming the norm, Getz explains. “The pandemic really opened CRO eyes to the role that more diverse datasets can play in supporting clinical studies,” he says.
As a result, CROs are leveraging data to meet the growing demand for innovative trial designs and personalised medicine approaches, explains Dave Bowser, Executive Vice President and COO of the CRO Worldwide Clinical Trials. “Trials are going to get smaller and become more complex, and we will rely more and more on technology to find the right patient populations and available patients,” Bowser says. In the rare disease and oncology spaces, where personalised medicine has the most momentum, innovative trial designs like Phase 0 studies and master protocols are gaining steam.
Meanwhile, the surge in healthcare data could open the door for new collaborations between academic research organisations and CROs. Academic research organisations have access to large datasets, which could pair well with the operational efficiency and organisation of CROs, explains Dr. Alexander Fanaroff, a cardiologist at University of Pennsylvania who has researched the rise of academic research organizations and CROs.
As CROs continue to scale up capacity to meet these new drug development demands, there has been widespread consolidation in the CRO industry. However, Getz says the moves toward personalised medicine and flexible outsourcing have still left ample opportunity for smaller sponsors to find boutique CROs that can cater to a specific need. “The largest market leaders are necessarily creating an environment where there is a limitation on the access to specialty services or some of the smaller CROs,” he notes.
Slowing down decentralisation?
Since the emergence of the Covid-19 pandemic, there has perhaps been no bigger buzzword in the clinical trial industry than “decentralisation.” In many ways, the reality matches the hype: there has been a steep rise in decentralised clinical trials, and experts say sponsors are looking for CROs that can handle services like remote trials and home visits.
Long-term, however, it will likely be individual patient communities that dictate the role of decentralisation as sponsors move away from a one-size-fits-all approach, Getz explains. “Some pharma companies are retrenching and taking a step back to think about how best to use decentralized clinical trials support,” he says.
VistaGen’s Singh adds that the key is finding the right balance between decentralisation and classical in-person trial strategies that present the best overall fit for a specific program. “The Covid-19 pandemic has illustrated the growing use and significant potential execution efficiencies offered by various decentralised clinical trial strategies,” Singh says. “There are also potential limits to their use that should be considered when planning certain types of studies—notably mental health trials involving neuropsychiatry.”
For example, while virtual enrollment and participation tools can diversify the potential study population, there are also eligible patients with mental illness who are not comfortable using the internet or data-gathering tools to participate remotely, nor do they want strangers to come into their homes during a trial, Singh explains.
Overall, CROs and sponsors will need to build trials that can flexibly adapt to new challenges and customise the level of decentralised tools—whether this entails full-service CROs or a series of specialty organizations with more sponsor control. “Big picture, we expect to see much higher levels of trial customisation,” Getz says.