Article

Clinical Trials Face Persistent Challenges—and New Opportunities

Bain’s survey of 120 sponsors, CROs, and trial site professionals shows persistent pressure on recruitment and site capacity, but also an opportunity to redesign work around AI.

Par Jackie Flanagan, Michael Nelson, Brittany Rodriguez, et Kristin Moneyron

First published on septembre 02, 2026
min


Clinical trial complexity continues to rise, and the pain points that frustrate sponsors, contract research organizations (CROs), and trial sites most have proved stubbornly resistant to fixing. To understand where the strain is greatest, how stakeholders are responding, and how far AI adoption has progressed, Bain surveyed 120 clinical trial professionals across sponsors, CROs, and trial sites. Their responses reveal an industry contending with familiar problems and only beginning to grasp where AI will help the most. Clinical trial complexity Trials are increasingly complex. No one expects relief. Most respondents say trials are more complex today than they were three years ago and expect trials to have even greater complexity in the coming years. % of respondents think trials are more complex today than they were 3 years ago % of respondents expect complexity to increase over the next 3 years Timelines are slipping more frequently. The share of trials experiencing at least a 20% delay is rising steadily, up from 44% pre-2020 to 54% today. Sources: Bain Clinical Trials Voice of Customer Survey, April 2026 (n=120); Bain Clinical Trials Voice of Customer Survey, 2022 (n=95) Patient recruitment and protocol amendments are increasingly challenging. While many causes of delays eased modestly in the last four years, patient recruitment, site activation, and protocol amendments persist as top reasons trial timelines are delayed. The persistence of recruitment pressure is not surprising—intensifying competition for a narrower, more precisely defined patient population is now a structural feature of modern trial design, and it isn’t going away. More trials are competing for fewer eligible patients, many of whom are well served by the standard of care, and additional spending alone won’t solve the problem. Note: Percentages show respondents who ranked each factor among their top three Sources: Bain Clinical Trials Voice of Customer Survey, April 2026 (n=120); Bain Clinical Trials Voice of Customer Survey, 2022 (n=95) Site frustrations Site bandwidth constraints will likely hold flat or worsen. Despite seeing some improvement since 2022, twice as many sites expect their capacity to worsen over the next three years as expect it to improve. Sponsors are planning to run more trials against a site landscape that expects to have less capacity to support them. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, site trials n=40) Sponsors and CROs have meaningful levers to address sites' two biggest headaches. Slow contracting and managing progress across multiple software platforms top the list of site frustrations. Both are areas where sponsor and CRO choices can materially reduce site burden. Sponsors can meaningfully improve contracting processes, while system proliferation is a direct consequence of their and CROs’ technology decisions. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, site trials n=40) Some sponsor and CRO investment is missing the mark. Improved site onboarding and ongoing support is both the most seen sponsor investment and one of the most impactful initiatives overall. But automated and passive data collection, which directly addresses system fragmentation by digitizing paper documents and streamlining data capture across platforms, has the largest gap between seen and wanted. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, site trials n=40) AI Almost everyone's piloting AI. A few are already leading. The gap between tool adoption and organizational redesign is the defining characteristic of where the industry sits today. A combined 65% of sponsors and CROs are piloting AI tools in clinical trials, and 16% are reshaping roles and workflows around AI capabilities, not just deploying tools within the ones they already have. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, sponsors and CROs n=80) AI’s impact starts with the data. Everyone agrees the greatest disruption will be to data management and cleaning. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, sponsors and CROs n=80) But AI leaders have moved past the data pipeline. Organizations still piloting AI rank data manager as the single role most likely to be disrupted. But those already redesigning don't even rank it in their top three, instead shifting focus toward the roles that touch trial operations and patients directly, such as trial monitoring and patient recruitment. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, sponsors and CROs n=80) AI and machine learning (ML) adoption is picking up. CROs and sponsors say the technologies are appearing in more trials, at least to some degree. However, most use them in under 25% of studies. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, sponsors and CROs n=80) True redesign is what powers the gains. Those using at least some AI or ML are already seeing benefits. But the organizations that are taking steps to redesign roles and workflows around AI report the greatest performance gains. A broken-out review reveals just how ahead these proactive redesigners are. Source: Bain Clinical Trials Voice of Customer Survey, April 2026 (total n=120, sponsors and CROs n=80) Questions for sponsors and CROs The findings point to a difficult reality: Trial complexity continues to rise, sites remain stretched, and AI is creating new possibilities without yet providing all the answers. For sponsors and CROs, the challenge now is deciding where to intervene and where redesign can make the biggest difference. Three questions stand out: What two or three areas will sponsors and CROs reinvent to differentiate with sites and improve experience? Where can AI leapfrog pain points, and where are traditional solutions better suited? How must the workforce evolve as trials and technologies grow increasingly complex? About IncQuery IncQuery is a leading programming provider of quantitative surveys for primary research. Its collaborative co-authoring platform, combined with support from experienced survey directors, empowers professionals to quickly launch high-quality surveys. Visit incquery.com for more information.

Clinical trial complexity continues to rise, and the pain points that frustrate sponsors, contract research organizations (CROs), and trial sites most have proved stubbornly resistant to fixing. To understand where the strain is greatest, how stakeholders are responding, and how far AI adoption has progressed, Bain surveyed 120 clinical trial professionals across sponsors, CROs, and trial sites. Their responses reveal an industry contending with familiar problems and only beginning to grasp where AI will help the most.

Clinical trial complexity

Trials are increasingly complex. No one expects relief. Most respondents say trials are more complex today than they were three years ago and expect trials to have even greater complexity in the coming years.

of respondents think trials are more complex today than they were 3 years ago

of respondents expect complexity to increase over the next 3 years

Timelines are slipping more frequently. The share of trials experiencing at least a 20% delay is rising steadily, up from 44% pre-2020 to 54% today.

Stacked bar chart of phase 2/3 trial delay severity pre-2020, three years ago, and today, split into limited, moderate, and significant delay. Significant delays held at 19% before rising to 22% today, while moderate delays grew from 25% to 32%. Limited delays shrank correspondingly, from 56% to 46%.

Patient recruitment and protocol amendments are increasingly challenging. While many causes of delays eased modestly in the last four years, patient recruitment, site activation, and protocol amendments persist as top reasons trial timelines are delayed.

The persistence of recruitment pressure is not surprising—intensifying competition for a narrower, more precisely defined patient population is now a structural feature of modern trial design, and it isn’t going away. More trials are competing for fewer eligible patients, many of whom are well served by the standard of care, and additional spending alone won’t solve the problem.

Bar chart comparing delay causes cited by sponsors and CROs in 2026 against 2022, by share ranking each in their top three. Patient recruitment rose sharply from 64% to 86%, and protocol amendments from 28% to 37%. The other three causes fell, with insufficient resourcing dropping most, from 34% to 22%.

Site frustrations

Site bandwidth constraints will likely hold flat or worsen. Despite seeing some improvement since 2022, twice as many sites expect their capacity to worsen over the next three years as expect it to improve. Sponsors are planning to run more trials against a site landscape that expects to have less capacity to support them.

Stacked bar chart of how 40 site respondents expect their bandwidth to change over the next three years. Just under half, 47.5%, expect no change. 35% expect capacity to worsen against 17.5% expecting improvement, with most of both groups choosing the slight rather than substantial option.

Sponsors and CROs have meaningful levers to address sites' two biggest headaches. Slow contracting and managing progress across multiple software platforms top the list of site frustrations. Both are areas where sponsor and CRO choices can materially reduce site burden. Sponsors can meaningfully improve contracting processes, while system proliferation is a direct consequence of their and CROs’ technology decisions.

Bar chart ranking the challenges site staff place in their top three for managing phase 2/3 trials today. Site contracting and activation leads at 45%, followed by progress management across multiple platforms at 35%. The remaining six challenges cluster between 30% and 20%.

Some sponsor and CRO investment is missing the mark. Improved site onboarding and ongoing support is both the most seen sponsor investment and one of the most impactful initiatives overall. But automated and passive data collection, which directly addresses system fragmentation by digitizing paper documents and streamlining data capture across platforms, has the largest gap between seen and wanted.

Horizontal stacked bar dividing sponsor and CRO respondents into three stages of AI maturity. Half, 49%, are piloting AI tools without having restructured roles, while 34% are in early planning, relying on vendors, or not treating AI as a priority. Only 16% are proactively redesigning roles.

AI

Almost everyone's piloting AI. A few are already leading. The gap between tool adoption and organizational redesign is the defining characteristic of where the industry sits today.

A combined 65% of sponsors and CROs are piloting AI tools in clinical trials, and 16% are reshaping roles and workflows around AI capabilities, not just deploying tools within the ones they already have.

Bar chart ranking where sponsors and CROs expect AI's greatest impact, by share placing each area in their top three. Data management and cleaning leads at 54%, ahead of protocol design and feasibility at 39%. The remaining seven areas cluster between 31% and 8%, with site activation last.

AI’s impact starts with the data. Everyone agrees the greatest disruption will be to data management and cleaning.

But AI leaders have moved past the data pipeline. Organizations still piloting AI rank data manager as the single role most likely to be disrupted. But those already redesigning don't even rank it in their top three, instead shifting focus toward the roles that touch trial operations and patients directly, such as trial monitoring and patient recruitment.

Bar chart comparing roles sponsors and CROs expect AI to heavily redesign in one to two years, split between organizations proactively redesigning roles and everyone else. Both groups rank medical writer first, at 69% and 60%. The sharpest divergence is data manager, ranked second by everyone else at 61% but fourth by proactive redesigners at 38%.

AI and machine learning (ML) adoption is picking up. CROs and sponsors say the technologies are appearing in more trials, at least to some degree. However, most use them in under 25% of studies.

Stacked bar chart of how many of their phase 2/3 trials sponsors and CROs use AI or machine learning tools in. The largest group, 38%, uses them in few trials, 1% to 25%, and 20% use them in none. Only 13% report use in most or all trials.

True redesign is what powers the gains. Those using at least some AI or ML are already seeing benefits. But the organizations that are taking steps to redesign roles and workflows around AI report the greatest performance gains. A broken-out review reveals just how ahead these proactive redesigners are.

Stacked bar chart comparing AI performance gains reported by organizations proactively redesigning roles against everyone else. Redesigners cluster at the top, with 41.7% reporting significant gains and 22.2% transformative, and none reporting no gains. Everyone else centers on moderate gains at 50%, with 7% transformative and 4.4% reporting none.

Questions for sponsors and CROs

The findings point to a difficult reality: Trial complexity continues to rise, sites remain stretched, and AI is creating new possibilities without yet providing all the answers. For sponsors and CROs, the challenge now is deciding where to intervene and where redesign can make the biggest difference. Three questions stand out:

What two or three areas will sponsors and CROs reinvent to differentiate with sites and improve experience?
Where can AI leapfrog pain points, and where are traditional solutions better suited?
How must the workforce evolve as trials and technologies grow increasingly complex?

About IncQuery

IncQuery is a leading programming provider of quantitative surveys for primary research. Its collaborative co-authoring platform, combined with support from experienced survey directors, empowers professionals to quickly launch high-quality surveys. Visit incquery.com for more information.