Clinical Trials Arena

A packed agenda at Arena International’s Outsourcing in Clinical Trials (OCT) West Coast 2025 conference, which took place at the Hyatt Regency San Francisco Airport, Burlingame, on 11 and 12 February, heard from speakers about the state of the industry and how to manage specific pain points.

There was a sense of relief amongst industry experts as they realised that everyone in the clinical trial sector is facing the same challenges.

From recruitment to engagement and trial set-up to regulation as well as recent political shifts globally, the clinical trial sector is facing a turbulent time and is preparing for more change on the horizon.

Recruitment and engagement struggles

Among all the new developments in the clinical trial sector, patient recruitment and engagement remain a severe pain point for sponsors in clinical trials.

Shantheri Pai, associate director of clinical operations for oncology at Gilead, shared her opinions on how making trials more site-centric will also trickle down in making them patient-centric.

“It goes hand in hand,” Pai explained. “We need to make sure site feedback is incorporated into future studies. We can’t just hear feedback, we need to be actively listening and executing. While we must also be transparent that we may not be able to incorporate 100% of that feedback immediately, the feedback should be considered for future process and trial design improvements.”

Nisha Trivedi, a rare disease patient advocate and former participant in two clinical trials for epidermolysis bullosa. Image credit: GlobalData / Abigail Beaney

Nisha Trivedi, a rare disease patient advocate and former participant in two clinical trials for epidermolysis bullosa (EB), highlighted her experience and how sponsors could run studies that will better engage patients.

“The records were made in a paper diary, but it was 2022. I had a binder where I was asked to fill out daily and weekly entries. Not only that but I took photos on a Canon digital camera that was around a decade old,” Trivedi explained. Adding that this was a real shock given the global technology that is easily available, asking sponsors to consider adding the ability to provide feedback and self-assessment and take photos on a mobile phone to improve convenience for the patient.

She also shared concerns about how trials measured endpoints and how they could be too subjective.

“I felt that there was some subjectivity to the scales. I would be asked to rate itchiness on a scale of one to 10. I would be thinking – what is a 10 and what is a five? As a patient, I was concerned I would not be providing the standard, objective responses the sponsor necessarily needed which concerned me.”

Shantheri Pai presenting at OCT West Coast 2025 - Her presentation focused on patient and site centricity — Shantheri Pai, associate director, Clinical operations for Oncology at Gilead Sciences said that it is vital for sponsors to reduce burden on the site if they also want to reduce burden on patients. Image credit: GlobalData

Not only was that a concern, but Trivedi also explained the need for site staff to better understand a patient’s condition before they work on the clinical trial.

“Overall, the trial site staff were knowledgeable, and they regularly expressed gratitude for my participation. There were however some issues with the evaluations needed – examples being the blood draw and the EKG. Given this was a trial for patients who have sensitive skin, I was asked whether I would be able to handle the adhesive for the EKG and the answer was absolutely not,” Trivedi said. “I had a similar issue with the blood draw when the site staff was looking for a vein, they rubbed my skin – the worst thing that you can do to an EB patient is to create unnecessary friction.”

Trivedi said she did report these issues to the team, and they were rectified for other patients. However, she believes that a basic understanding of the disease is needed to retain patient trust in trial participation.

Regulatory alignment is improving

Another issue which has plagued the industry is regulatory challenges in the set-up of global trials. While many sponsors take the approach of meeting the desires of the strictest regulatory agency, this can be met with resistance by sites that may be overburdened.

Katie Bessette, who is the director of regulatory affairs at Abbott Laboratories, held a session about the US Food and Drug Administration (FDA) draft guidance on informed consent in trials. Although Katie said she had not put the guidance from the FDA, the European Medicines Agency (EMA) and China’s National Medical Products Administration (NMPA) side by side, she did believe that the agencies have been working hard to become more unified in their approaches. Katie added that the FDA has done a good job of alignment across pharma, medical devices and diagnostics.

The exhibition room at Outsourcing in Clinical Trials West Coast 2025. Image credit: Arena International

Leesa Gentry, chief clinical officer for the San Jose, California-based RenovoRx, sat on a panel about the change in regulatory alignment on a global scale.

“Back in the 2000s, I sometimes felt, certainly in APAC and South America, that when we met with regulators either everything or nothing was possible because their infrastructure wasn't robust at that time, but I do think that has changed,” said Gentry. “Now, if you have a study that has been reviewed by the FDA or the EMA, the trial is much more likely to get accepted. Not just that but in the Philippines, South Korea, other parts of APAC and South America, I've seen a shift in the timelines for a regulatory startup from more than a year previously to six to eight months now. I do believe we are moving in the right direction,” Gentry said.

Chair Susan Edelstein, from Ardelyx opening the Outsourcing in Clinical Trials West Coast 2025 conference. Image credit: Arena International

China may fill research hole

One shocking revelation at the conference was how China is stepping into the research space. Research by GlobalData revealed that China has taken over the US as the global leader in annual clinical trials – but most of the studies are single-country trials.

Speaking at the conference, Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData, said that the country overtook the US in 2021 and has remained the biggest contributor globally ever since. As a result, there is a chance that outsourcing companies may look over to China for research possibilities.

“What does that mean for us in the US, especially for outsourcing of clinical trials? Where are the opportunities? Are there new business opportunities for CROs, CMOs and pharma for their clinical operations?” Tatake asked.

Meanwhile, the US’s withdrawal from the World Health Organization (WHO) could impede the US’s contribution to research globally according to Archana Sah, founder of AS Pharma Advisors and oncology board member for the Society for Clinical Research Sites. Sah explained that the US will “lose out” on important research should the US go through with the withdrawal.

Archana Sah spoke about how the US's withdrawal from the WHO will have a global impact. Image credit: Abigail Beaney / GlobalData

“US researchers do stand to lose out on many fronts like limitations to key data access on diseases across the globe, reduced international collaboration, disruption of global standards potentially impacting the comparability of data, reduced funding of global health research-including clinical trials in low resource settings,” Sah said. “Countries like China could move ahead and take over this research leadership.”

The Outsourcing in Clinical Trials West Coast 2025 conference is organised by Arena International, a part of GlobalData, which is also the parent company of Clinical Trials Arena.