Clinical Trial Startup: Insights from the Industry
The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Each of these have contributed to a rapidly evolving clinical research landscape.
To learn more about the influx of sponsor-provided technology, site enablement tools, and their impact on study startup over the past five years, Advarra surveyed clinical research professionals in late summer 2023. The 2023 Study Activation Survey Report provides insights gained from over 500 North American clinical researchers and gives recommendations on improving the overall site experience during trial activities. This blog uncovers key findings from survey respondents.
Growth in Volume
About 60% of survey respondents said their study volume is higher now than compared to 2018. In parallel with a higher trial volume, 67% of respondents indicated sponsor technology setup and training is more burdensome now than five years ago. The most burdensome activities included:
- Sponsor technology setup/training
- Site training
- Managing/Tracking referrals
- Feasibility survey completion
- Essential document collection
Conversely, the least burdensome study activities include:
- Patient retention
- Ethics submissions
- Recruitment from own database
This growth in study volume comes with opportunities and challenges for research sites. Navigating this surge requires a blend of expertise, from understanding patient populations to streamlining startup activities.
Sponsor Technology and Training
The role of technology in clinical trials has never been more pronounced. As the industry leans into digital transformation, there is an even greater emphasis on sponsor technology and training. In the past five years alone, the use of sponsor-provided technology in studies has grown.
The most popular sponsor-provided technologies include electronic data capture (EDC), interactive voice response systems (IVRS), and safety letter acknowledgment. However, respondents said sponsor-provided technology was the most burdensome. Although sponsors have technology in place to ease trial operations, it’s likely these platforms are making it more difficult for research staff to perform their jobs efficiently.
For example, with more technology platforms comes more login credentials to remember. When asked, about 70% of respondents said they had six or more logins to remember per study. And that’s just for one study – if they are working on more trials, the chances they have more logins to remember is greater. More than 80% of those taking the survey said using their own site credentials would be valuable as they logged into various platforms during the trial.
Feasibility questionnaires play a pivotal role in determining a site’s capability. From evaluating exclusion criteria to understanding the intricacies of the clinical trial protocol, feasibility surveys can be the bedrock of successful trial startup.
Even though they are pivotal to success, sites are often frustrated with the information sponsors and CROs choose to collect in their feasibility surveys. These questionnaires are viewed as time-consuming and redundant since sponsors and CROs continually ask sites to provide the same information over and over – sometimes, even to the same sponsor.
As the volume of research studies has increased, so has the volume of feasibility surveys. About half (49%) of respondents said their feasibility survey load has increased over the last five years. With the influx of surveys, however, less than half (46%) reported their feasibility surveys are more focused on study-specific questions now versus five years ago, and 38% said there was no difference. This suggests there is an opportunity for sponsors and CROs to streamline the survey process.
Contracting and Budgeting
Generally, site contracting and budgeting are the most involved aspects in study startup. In total, 67% of respondents indicated they always or often leverage existing terms. Even if a sponsor or CRO agrees to terms with a site, negotiating contracts and budgets still contributes to site activation delays.
More than one-fourth (26%) of sites indicated it takes them up to eight weeks to negotiate a contract with a sponsor or CRO; sometimes, it takes them longer. One-third of respondents said it takes the same amount of time to agree on a budget.
These timelines vary between the types of site organizations. About 30% of academic medical centers (AMCs) said it took them more than three months to negotiate contracts, compared to 14% non-AMC health care providers (HCPs) and 7% professional sites and site networks. The budget approval process is similar: 16% of AMCs complete negotiations in four weeks or less; 47% for professional sites and site networks.
Updated research appears to show there are still challenges surrounding adoption and integration of sponsor-provided technology and processes. Particularly, there are significant opportunities for sponsors, CROs, and sites to improve feasibility surveys, contracting, and budgeting processes. Our full survey report breaks down these insights further, providing additional perspective into barriers and challenges for study startup activities.