According to a study conducted by the Tufts Center for the Study of Drug Development, the average study activation time is a full month longer than it was 10 years ago. While there are a number of factors that contributed to the increase, including a higher number of new site initiations and increased trial complexity, this eye-opening statistic makes it clear that delayed study start-up is a chronic problem in the research industry.
Over the years, the industry has worked to find a way to streamline the study start-up process through best practices, technology and services. However, improving processes during study activation is only part of the solution. Relationships between stakeholders, particularly clinical research sites and sponsors, are incredibly influential to expedited study activation and poor communication can lead to delays both during start-up and later in the study. In this infographic, we examine how both sites and sponsors can improve communication and organizational practices in three key areas: enrollment estimates, feasibility questionnaires and protocol complexity.
You can also download our free eBook Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials to learn more steps sites and sponsors can take to improve relationships and speed up study timelines.
Both sites and sponsors can take steps to improve how to predict and create enrollment targets, assess trial feasibility and effectively gauge protocol complexity.
Defining targets and accurately predicting enrollment numbers can be a guessing game. Lack of communication between stakeholders leads to over- or under-estimated enrollment numbers, ultimately setting sites up for failure.
According to the Tufts University CSDD report in 2013, 39% of sites meet their enrollment targets2, 37% of sites under-enroll2 and 11% of sites in a given trial fail to enroll a single patient2.
Honest and open communication between sites and sponsors upfront so everyone is aware of necessary study details and has what they need to ensure accurate estimates.
For more accurate enrollment predictions, sponsors should allow sites to explain variables to estimates, tell sites where they are in the process and share changes to I/E criteria with sites and let them update their enrollment numbers. Sites should showcase past enrollment performance, be honest about competing studies, don’t over estimate enrollment potential and get what’s needed from the sponsor to be more precise.
Clinical trials are often under way before the site and sponsor truly have the information necessary to ensure the study is productive downstream. This leads to a lot of extra time and resources in the study start-up phase.
Eight months is the average time to move from pre-visit through to site initiation and the estimated cost of initiating a site is between $20,000-$30,0003.
To enhance feasibility assessments, sites should improve feasibility questionnaires and only participate on trials that are mutually successful.
Sponsors can enhance feasibility by:
- Giving sites enough time for thoughtful answers.
- Making simple changes to your traditional questionnaire.
- Identifying the right point person to answer questions.
- Follow up with ALL sites submitting a questionnaire.
For sites, can enhance feasibility by:
- Picking up the phone and talking to the sponsor.
- Don’t just tell the sponsor what they want to hear.
- Doing a reverse feasibility questionnaire.
- Knowing deal breakers and when to walk away.
The growing complexity of clinical trials, on top of amendments and changes coming up mid-study, making it even more difficult for sites to determine whether or not they can address all study requirements.
A 2008 Tufts CCSD study of unique phase 1-4 protocols conducted between 1999 and 2005 showed5:
- 6.5% annual increase in number of unique procedures per protocol.
- 8.7% annual increase in frequency of procedures per protocol.
- 10.5% increase in investigative site work burden to administer each protocol.
To gauge protocol complexity more effectively, sites should understand and align expectations about protocol complexity, providing a clear picture of what conducting the clinical trial entails. Sponsors should also set expectations with sites, asking for input on the protocol design and provide sites with the training and resources needed. Sites should also identify staff bandwidth and required resources, practice walking through the motions before scaling and do a break-even analysis.
- Tufts Center for the Study of Drug Development, Impact Report Vol 15, No 1, Jan/Feb 2013, https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa2c28fec212d492f36cc8a/1520616079359/Jan-Feb+2013+IR+summary.pdf
- START Study Tufts CSDD, 2012. Ken Getz’s presentation entitled: Uncovering the drivers of R&D costs.
Streamlining study activation begins by ensuring all involved stakeholders have the tools and information they need to perform critical start-up tasks. Download your copy of the free eBook Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials to learn more steps sites and sponsors can take to improve relationships and speed up study timelines.
For ideas that can helps sites and sponsors improve their partnerships, download the eBook, Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.