At PAREXEL, we frequently get asked questions about protocol optimization – what it is, how it works, and trends in…
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Biopharmaceutical companies continue to explore ways to make clinical trials more efficient and effective at each phase of the drug development journey. This is especially the case when it comes to trial feasibility and patient enrollment. Effective management of these aspects can separate an effective trial from an unsuccessful one.
An aligned, comprehensive approach is essential. For example, PAREXEL has combined Feasibility, Patient Recruitment, Site Alliances and Site Intelligence into a single group for developing a successful trial operational strategy: the right countries, right sites and right patients. This enables clients to benefit from application of a more coherent strategy.
Innovation is also essential for successfully managing trial feasibility and patient enrollment. PAREXEL has developed a survey to obtain investigator input into studies up front, and has now completed nearly 100 of them. These surveys are in addition to traditional feasibility questionnaires and capture the perspectives of the investigator community beyond just protocol considerations. The Company also works with vendors to access international electronic health record (EHR) information and is developing a tool to query EHR databases from multiple U.S. and European vendors. This helps identify the potential for conducting a clinical trial in specific countries and better target patients. It also helps companies navigate EHR complexities, as PAREXEL will have already analyzed different available data sources and negotiated competitive rates ahead of time.
In addition, proactive and constant web listening is critical for gaining insights into how patients will view their trials and how investigators will react. Not only does this guide feasibility estimates, but it also helps position trials with these two critical groups when reaching out to them. Related to recruitment, PAREXEL is leveraging Facebook and other social media apps, as well as its own web-based platform, to recruit and retain patients. Such innovation is helping to make key parts of the clinical trial process more efficient and effective.
Patient Recruitment: Essential Yet Challenging
While technology innovation is being applied to trial feasibility analyses, it must also be used to address the critical task of patient recruitment. Ironically, although patient recruitment is becoming increasingly challenging, it isn’t often fully addressed until a study faces enrollment difficulties. In fact, 80 percent of industry clinical trials do not meet their recruitment targets on time. Although the science behind a clinical trial may be well conceived, a company still must ensure patient recruitment is consistent with the study design.
To be successful, a clinical trial must take the patient’s perspective into account. What would make a patient willing to participate in a trial? How could it be made easier for a patient to participate? What protocol changes could a CRO recommend to make it more likely a patient will volunteer? How could CROs make it easier to retain the patient? As protocols become more complex, biopharmaceutical companies are seeking to extract greater benefit from their studies and protocols have become increasingly demanding of investigators and patients.
It is important for study design to be patient- centric and for trial feasibility and enrollment efforts to emphasize patient understanding: what they think about a particular disease, how it affects them in real life and how a biopharmaceutical service provider can design a study to make it as easy as possible for the patient to participate. PAREXEL is addressing this issue by increasing the number of patient feasibility surveys conducted across the globe as well as developing our own patient panels to support additional surveys.
PAREXEL is also applying its Medical Communications expertise to patient recruitment and retention. A unique tool will provide clients with a cost-effective solution to the complex task of website design. The Company is also developing an online ICF tool that will help patients and their families understand the details of trials and the commitment they are making, while making it easier for site staff to take them through the trial process. As part of a drive to make it easier for busy site staff to deliver a study for PAREXEL and our clients, we also have a suite of mobile phone apps under development to support site staff in having critical conversations with potential study patients and providing reminders of key visits and study tasks.
Globalization of Recruitment Innovation
One trend that can’t be ignored is globalization of recruitment innovation. Historically, many patient recruitment tactics have been U.S.-centric, followed by some parts of Western Europe. In the future, there will far more use of these tactics in emerging markets.
PAREXEL’s GRIP (Global Recruitment Intelligence in PAREXEL) database pulls together our corporate knowledge and draws on the experience of some of our patient recruitment vendors to provide a comprehensive overview of recruitment tactics in every country where the Company operates, and identifies specific challenges in deploying them.
Often the barriers to successful recruitment can be linked to a lack of awareness about what is acceptable in different countries. However, PAREXEL’s database captures what is culturally acceptable and what is permissible by regulators and Independent Review Boards.
Feasibility and Recruitment Trends and Issues
PAREXEL is witnessing and addressing the greater demand for a data-driven approach to clinical trial feasibility and patient enrollment. The traditional approach to feasibility involves surveying investigators and asking for their opinions. However, this method is increasingly incomplete; investigators can provide a broad range of valuable information, such as the standard of care in their clinic or country, but relying on them for recruitment rate estimates has often proved unreliable.
In the future, leading biopharmaceutical service providers will increase their use of electronic health records to better understand the available population a protocol has defined. This will lead to more reliable estimates. PAREXEL already uses the Citeline commercial database, which provides a clearer picture of what other studies have achieved in terms of recruitment rates in comparable studies. In the future, there will be much more data available through the Internet. Those biopharmaceutical services providers that can leverage their global expertise and innovation, and augment their capabilities with external partners in a holistic, integrated manner, will be most effective at simplifying clinical trial feasibility and patient enrollment for their clients.
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