It has been a turbulent time for the pharmaceutical industry – especially in regard to the clinical trial sector. From reduced investment, to a lack of public trust in the industry, it has been difficult, especially for small and medium-sized biotech’s, to get efficient clinical trials off the ground.
On top of these challenges, the industry has also seen a change in demand, with the types of therapies in the pipeline, such as cell and gene therapies, requiring a shift away from the gold standard randomised controlled trial (RCT) model. As a result, companies have had to learn how to effectively run adaptive trial designs, while tackling small patient numbers and providing sufficient data to regulatory authorities.
Go deeper with GlobalData
Other challenges, including shifts with new government administrations, and new regulatory guidance and legislations will likely cause further upheaval in 2025.
Better trial designs will be key in 2025
As more advanced therapies move their way into the clinic, sponsors and biotech’s are looking to improve trial designs to better evaluate the efficacy of a therapy.
Steve Herne, CEO at Unlearn says as a result, this is providing new problems for sponsors. “Trials are getting more complex and expensive as they target smaller, more specific patient populations, rely on larger and more diverse datasets, and navigate stricter global regulations,” Hernes explains. “We’ll need to design trials that are smarter and more efficient, plan our operations carefully, and stay nimble as the landscape keeps evolving.”
It will therefore be more important than ever, especially for biotech’s with less cash reserves, to ensure a higher level of confidence in therapies before clinical trial initiations. Orr Inbar, CEO, and co-founder of QuantHealth, an AI-powered clinical trial design company, says: “I think we will see better science before going into a trial to ensure the right therapy and right trial is being conductive. I also think we will see a resurgence of adaptive trials such as umbrella and platform trials. CROs may be worried as CRO costs have been ballooning over the last decade. Efficiency and reducing the number of trials and trial size puts fear into the CROs.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
Global political changes could cause big shifts
2024 also saw a shift in politics, with Donald Trump winning the Presidency in the US. This is anticipated by many major pharma companies to cause a change in the clinical trial landscape.
“Regulatory priorities might shift—an administration focused on deregulation could speed up approval pathways, which might bring new opportunities but could also raise concerns about cutting corners,” Herne explains. “An administration pushing stricter oversight could slow things down but might help build trust in trial outcomes in the long term.”
Inbar believes there could be a push for deregulation under the Trump administration. “As part of the new administration, we could see a big push for deregulation. The focus on efficiency from Musk means the FDA may become more open to adopting and driving the incorporation of more risk and beneficial technologies to address these challenges.”
True impact of new legislation will be revealed
There have been several legislative and regulatory changes in the past 24 months which experts believe will start to take full effect in the next 12 months.
Ariel Katz, CEO of H1, believes that 2025 will start to reveal the true impact of the Inflation Reduction Act (IRA), estimating it will impact the number of clinical trials initiated in the US.
“As pharmaceutical companies shift their focus toward fewer, high-value therapeutic areas in light of the IRA’s drug price negotiations, the overall number of clinical trials will go down. Additionally, we’ll see a move to multi-indication trials to maximise profitability.” Katz explains.
Given the struggles that small and medium-sized biotech’s have faced in the past five years due to a drop in investment, the ability to reduce trial costs will be enticing.
On the downstream, however, Katz believes the impacts of the IRA will lead to fewer new drugs making it through trials and entering the market, limiting treatment options for patients.
Differing regulations remain a challenge in global trials
On a global scale, Zee Zee Gueddar, senior director commercial at IQVIA, believes that regulatory disparities will impact global studies.
“One of the most prominent challenges will be the growing complexity of global trials, with sponsors needing to navigate an increasingly intricate regulatory environment across diverse international markets,” Gueddar says.
There will also likely be developments in patient reimbursement, which is one of the biggest barriers for sites and sponsors in patient enrolment and retention.
Kevin Coker, former CEO at Proxima Clinical Research (a CRO based in the Texas Medical Center) and who currently serves as an Innovation Strategist and Head of MedTech Development at MD Anderson Cancer Center added: “Running trials across different countries sounds great but navigating different regulations, cultures, and standards is no small feat.”
Diversity guidance helpful but challenges remain
One of the biggest recent advancements in the clinical trial sector is the release of definitive guidance for improving the enrolment of diverse populations in clinical trials from the World Health Organization, the US Food and Drug Administration (FDA) and the European Medicines Agence (EMA). Dr. Stacie Bell, executive vice president of Lupus Therapeutics, said she is pleased that the industry appears to be responding well to agency recommendations.
“I look forward to diversity action plans to be enacted in future trials,” Bell said. “This is extremely important to ensure that diverse populations are included in clinical research – that is a big assistance to the challenge that we’re facing in that area.”
eClinical Solutions’ chief delivery officer of biometrics, Katrina Rice, agrees. Rice said: “2025 seems poised for transformative progress in diversifying clinical trials. To overcome challenges in meeting these diversity goals, sponsors will increasingly need to explore unconventional recruitment avenues. Collaborating with community organisations such as urban leagues, faith-based groups, and historically Black colleges and universities (HBCUs) is a particularly effective approach. These partnerships can foster deeper community trust and reach participants who have historically been underrepresented in clinical research, addressing both awareness and accessibility challenges.”
Coker says however that due to issues in trust with the industry, guidance alone will not be enough to improve diversity in studies. “It’s tough to recruit diverse groups of participants, and even harder to keep them engaged. Some people don’t know trials exist, while others might find them inconvenient or too much of a burden. On top of this, some people are sceptical about the pharmaceutical industry or fall for health misinformation, which doesn’t help when trying to recruit participants,” Coker explains.
Patient benefit should be considered
Of course, in all trials, patients should remain at the heart of all decisions, but at a time when trust in the industry is low, this will continue to be a test in 2024.
“Clinical trial participation is about striking a balance and most importantly to that balance is putting the patient’s voice at the centre” Bell adds. “The trial design needs to consider what is most convenient for participants, not just what is most convenient for a pharmaceutical sponsor or a site. Participating in a study should provide benefit to patients and not burden.”
“In an industry already challenged by patient enrolment and participation, organisations realise they will require more flexible and timely payment processes to improve clinical trial outcomes. As clinical trials continue to grow in size and geography, across multiple countries, multiples languages and currencies, sponsors and sites will seek to improve payment processes that can accommodate this growing complexity,” Gueddar concludes.
