Clinical trial management has evolved rapidly in recent years – particularly as patient recruitment and trial execution have become more complex, and COVID-19 inspired a transformation of traditional trial structures.
As such, drug developers are adopting methods such as decentralized trials (or partnering with providers) and identifying areas for operational improvement to advance clinical research.
The PPD clinical research business of Thermo Fisher Scientific recently surveyed 150+ leaders at drug development companies worldwide to gather their insights on trends in pharmaceutical research and development.
Over half of the survey respondents reported their organization now utilizes the following innovations, strategies and technologies:
- Adaptive trial design (64%)
- Digitalization (e.g., cloud computing, APIs, digital platforms) (62%)
- Greater use of real-world data (RWD)/real-world evidence (RWE) (59%)
- Big data and analytics (53%)
- Decentralized, digital and remote trials (50%)
Keep reading to learn more about these approaches and what to look for in a clinical research partner.
1. Adaptive trial design
According to the FDA, adaptive trial design references a study design that “allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial.”
Adaptive designs are “smart.” They allow drug developers to use resources and time much more efficiently, while increasing scientific precision. Sponsors that adopt adaptive trial designs see reduced costs and streamlined development processes.
To gain an edge with this innovative approach, drug developers should look for a partner that delivers extensive experience in designing and operationalizing adaptive trials, has a wealth of biostatistical, medical and regulatory experience, and possesses deep and diverse therapeutic expertise.
Digitalization of clinical trials involves the use of a variety of technologies to improve patient engagement, study conduct, and data gathering and reporting, and has potential to lower costs and improve speed to market.
Drug developers should seek partners who have a demonstrated commitment to best-in-class technologies and combine new and innovative solutions with simplified processes and real-time analytics.
3. Greater use of RWD/RWE
Because clinical trial diversity remains one of drug developers’ biggest challenges, RWD is particularly important in compensating for limitations in clinical trial representation. It is impossible to execute a global clinical study that fully includes all patient, lifestyle, environmental and genetic types. In order to get as close to causation as possible to evaluate drug efficacy, sponsors should be ready to supplement trial results with RWD.
The use of RWE (clinical evidence derived from RWD analysis) continues to evolve. With RWE’s growing importance in demonstrating value for market access and commercialization, drug developers must navigate a myriad of data sources, extract the most relevant and valuable insights from that data, and analyze the insights to drive decision-making.
A key to success is to partner with a team of experts in evidence-based solutions that has a deep understanding of and experience in extracting valuable insights from RWD. This team will design and execute prospective data collection, direct-to-EMR, direct-to-patient or hybrid study approaches that result in tailored, fit-for-purpose data for your study.
4. Big data and analytics (data science)
Medical decision-making is becoming more dependent on data analysis, particularly large and complex data sets. At the same time, in PPD’s survey, more than half of respondents noted clinical trial complexity as a challenge. In the face of these realities, drug developers should look to a partner that has a strategic approach to big data, putting it to use to: sharpen focus on direct-to-patient engagement campaigns and community outreach, get trials up and running quickly, and meet diverse enrollment goals in record time.
5. Decentralized, digital and remote trials
Decentralized methods have now become a mainstay in clinical research. As an expected aspect of studies, drug developers should partner with contract research organizations (CROs) that are adept in executing decentralized clinical trials and utilize a variety of capabilities and solutions — including telemedicine, direct to/from patient models, remote consent, home health care and nursing, devices and wearables, and remote monitoring.
To learn more about the additional methods drug developers are exploring and pursuing to ensure clinical trial success, read the full findings of PPD’s data-driven report and discover ways to embrace innovative approaches to clinical research.