New Report Reveals Trends, Opportunities in Drug Development
We surveyed 150 drug developers around the globe to assess drug development trends and opportunities. Here’s what we found.
As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.
The PPD clinical research business of Thermo Fisher Scientific has surveyed more than 150 drug developers around the globe to gather annual data on trends in pharmaceutical research and development. Now in its second year, the survey enables detailed directional insights and industry changes over time.
The findings reflect the growing importance of patient diversity and the increasing complexity of trials, with geography and company size affecting sponsors’ goals, greatest difficulties and chosen approaches for growth. Respondents illuminated the challenges, opportunities and innovations affecting their drug development processes, as well as the shifting areas of interest and varying levels of optimism regarding patient recruitment.
Four Trends Drug Developers Need to Know to Succeed
- Recruiting patients for clinical trials continues to be the top organizational pain point facing sponsors, followed by the complexity of clinical trials.
- Participants noted several areas of opportunity, including greater use of AI applications and real-world data (RWD)/real-world evidence (RWE) to complement data from clinical trials.
- Digital and decentralized clinical trials (DCTs) continue to expand and have become a standard solution for drug developers. Respondents predict that in two years, 90% of trials will include DCT elements.
- The combined use of functional service provider (FSP) and hybrid models outpaces reliance on full-service outsourcing (FSO).
- The drug development activities most likely to be outsourced in the next two years are patient recruitment, clinical laboratory and diagnostic services, and RWD/RWE utilization. In contrast, study design and product registration are the least likely to be outsourced.
- Clinical trial speed still lags, with 41% of survey participants reporting that the average timeline to produce a drug moves more slowly than two years ago. However, this percentage represents a decrease from the 48% who reported decreased speed in 2022.
- Smaller sponsors have been lengthening clinical trial timelines, while larger sponsors and sponsors in Asia have successfully managed to shorten them compared to two years ago.
These findings provide more evidence that pandemic-driven shifts are becoming cemented as standard operating practices. As such, clinical trial sponsors are embracing both current solutions (including implementing decentralized approaches, developing guidance to drive greater inclusion and using digital platforms for improved tracking) and employing innovations, strategies and technologies from big data to adaptive trial designs.
Patient Recruitment and Complex Trials: Top Hurdles for Drug Developers
Drug developers share a common sentiment: Recruiting the planned sample size within a defined time frame remains “the chief bottleneck in the drug development process.” Survey respondents’ rankings of the two most significant organizational pain points underscore this concern.
The first is an ongoing challenge with aspects of patient recruitment in clinical trials, particularly patient retention and addressing patient population diversity (55% of respondents). Historically, clinical trial populations were almost exclusively comprised of white, male participants, exacerbating gaps in knowledge of diseases and conditions, preventive factors and treatment effectiveness.
Over the past two years, the results show a moderate increase in optimism regarding the recruitment of a qualified, diverse patient set. However, an equal number of respondents indicate no significant change in their ability to achieve diverse patient enrollments compared to those reporting a positive change.
Large sponsors and those based in Asia express greater optimism about patient recruitment. Despite larger sponsors noting a decline in their ability to achieve diversity targets, they are currently prioritizing patient diversity as a top strategy and dedicating resources to that end. Asian respondents exhibit a greater likelihood of utilizing big data, which may explain the increased optimism toward patient recruitment, suggesting the effectiveness of leveraging computational analytics for solutions.
The second most reported challenge (41% of respondents) is the increased complexity of clinical trials. Clinical trials continue to increase in complexity, especially oncology trials, which are still the fastest-growing area of drug development. The total number of investigational treatments targeting cancer nearly quadrupled over the past two decades (2000–2020), from 421 to 1,489. Overall, since 2013, the total number of trial objectives, endpoints and eligibility criteria has grown across all clinical trial phases, likely driven in part by the robust growth of oncology trials.
Trends Driving Transformation in Clinical Trials
Geographic-specific trends reveal a unique distribution of approaches and priority growth areas.
- In Europe, a profound shift toward innovative trial design has captured the attention of sponsors. By utilizing cutting-edge technologies and adaptive protocols, researchers aim to optimize efficiency, accelerate patient recruitment and enhance data quality in clinical trials.
- In Asia, personalized and precision medicine has become the driving force behind transformative clinical trials. Focusing on tailoring treatments to individual patients based on genetic, lifestyle and environmental factors, precision medicine offers more targeted and effective therapies while minimizing side effects.
- In the United States and Canada, a dual trend of RWD utilization and innovative trial design shapes the clinical trial landscape. Incorporating RWD alongside novel methodologies allows for a broader perspective on treatment outcomes and safety profiles, opening new possibilities for impactful and efficient research.
Differences in strategy also vary by sponsor size. Larger sponsors worldwide are keenly interested in leveraging RWD and embracing new technologies to enhance patient diversity, patient centricity and personalized medicine. In contrast, smaller sponsors are focusing on innovative approaches to investment and funding, adapting to the competitive clinical trial landscape.
Artificial Intelligence in Clinical Trials: Bridging the Gap Between Potential and Adoption
Artificial intelligence (AI) stands out as the second most influential force driving transformation in drug development. AI is ranked by 41% of respondents as a top 5 current trend driving clinical trials forward. However, it ranks last when it comes to its current implementation and usage, indicating a significant gap between potential and actual adoption. However, new technologies present major opportunities to expedite clinical trials.
For example, AI automation can analyze vast datasets, including RWD of patient profiles. It can predict molecular activity, toxicity and interactions, reducing the need for time-consuming experiments and enabling informed decision-making. Successful market access and product update stems from valuable RWD and RWE regarding a product’s safety, effectiveness and value. Robust early development clinical trial programs rely on real-world evidence of benefits and risks, and AI can fast-track this analysis.
Secondly, implementing AI could streamline patient recruitment by efficiently matching eligible individuals with appropriate clinical trials by analyzing electronic health records and patient data. Additionally, AI-driven predictive analytics can use both historical and real-time trial data to foresee and navigate potential challenges and outcomes, resulting in more efficient and adaptive trial designs, resource allocation, quicker decision-making and optimal treatment identification.
Drug Developers Who Respond with Solutions to Industry Challenges and Opportunities Will Gain a Competitive Edge
Drug developers have adjusted and tackled some of their biggest challenges post-pandemic by embracing innovations, tested strategies and new technologies. As the industry shifts, developers should remain nimble and implement solutions that provide them with a competitive edge.