Vice President, Head of Development Operations-Biopharma, PPD Clinical Research, Thermo Fisher Scientific

Matt Latey

The clinical trial landscape is more crowded than ever, with nearly 60,000 studies launched worldwide in 2021 alone.

 This expansion of clinical research will undoubtedly bring thousands of patients with life-altering conditions closer to therapies and cures. However, the busy research landscape is also demanding that sponsors and key stakeholders transform how to set up their clinical trials up for success.

The boom in trial volume presents new challenges to clinical trial organizers and administrators throughout the industry. More than 80% of clinical trials fail to meet enrollment goals on time, leading to significantly prolonged study timelines, protocol amendments, and increased costs.

 As drug developers prioritize more advanced, targeted therapies, competition to recruit from limited candidate pools within specific research indications also has increased dramatically.

Despite these challenges—in addition to high rates of turnover among clinical research staff and increasing trial complexity—the launch of new therapies hinges on sponsors’ ability to accelerate their trials and ensure they run efficiently.

 So how should biotech and biopharma organizations adapt their clinical trial strategy in an increasingly busy environment?

In this article, we’ll discuss five key areas to consider from the onset of a trial to make your study a priority in this crowded field.

1. Engage with clinical trial stakeholders from the start

What is one simple way of understanding what trial sites and participants need for a study to run smoothly? Proactive communication. It may seem obvious, but sponsors that seek and incorporate perspectives from sites’ staff and potential participants as early as possible in the trial planning and startup process are more likely to succeed in operationalizing truly patient- and site-centric trials.

 Early engagement ensures the goals and parameters of the study are realistic for those who develop, manage, and participate in clinical trials.

For example, site staff can provide valuable insight regarding the targeted patient population, potential recruitment numbers, and best practices and lessons learned at their site, which then influences development of feasible enrollment timelines and inclusion parameters. Additionally, a recent mandate by FDA requires sponsors to submit a “Race & Ethnicity Diversity Plan” for every study to ensure adequate representation of traditionally underrepresented groups in clinical trials.

 By seeking input from the target patient population in the conceptualization of their trial development and diversity plans, sponsors

Can create effective strategies to reach patients from diverse and underrepresented backgrounds;

Develop more inclusive, culturally appropriate trial plans; and

Potentially avoid costly protocol amendments and delays.

2. Take a data-driven approach to identify new sites and patient populations

Many sponsors lean on the same sites for study after study, leaving other potential sites, physicians, and patient populations unknown or untapped. A data-driven approach, leveraging multiple data sources, offers drug developers potential competitive advantages such as: trial optimization; expanded site and patient networks beyond “usually” crowded and constantly tapped sites; and new patient populations.

The feasibility process conducted by a clinical research organization (CRO) is crucial to introduce new sites to clinical research and have them join the clinical trial landscape. CROs must conduct extensive feasibility analyses and follow detailed processes prior to finalizing site identification and selection for an upcoming clinical trial. This process is executed in close collaboration with sponsors and even vendors involved in the clinical trial.

With access to deep and transparent site data, CROs have a proven, data-driven methodology to guide sponsors through the site-selection process. This wealth of data is paramount not only to identify and highlight well-equipped sites, but also to identify underutilized sites with the potential to bring value to the clinical trial. For example, if a feasibility analysis reveals that a potential site has a strong patient pool but lacks the staff or specialized equipment required for the trial, CROs and sponsors can work to fill these resource gaps.

3. Leverage new technology—but do so intelligently

As the clinical trial landscape grows, so does the range of new study tools, capabilities and approaches enabling a trial to become “decentralized.” The PPD clinical research business of Thermo Fisher Scientific recently surveyed more than 150 drug developers across the globe on pharmaceutical and biotech R&D trends and found that, among organizations currently using decentralized trials, usage is expected to jump 24% over the next two years.

 Even organizations not yet using decentralized trials anticipate 27% of their clinical trials will employ this approach by 2024.

However, many trial sites are struggling to cope with the implementation of these decentralized methodologies. While technological developments enable the collection of novel and more complex data and improved data integrity, they also burden already overwhelmed site staff and site support mechanisms. The Society for Clinical Research Sites recently found that 60% of sites use more than 20 systems on a daily basis, and that some sites have turned down studies based on protocol technology.

To enable efficiency, when planning a clinical trial, take time to evaluate the applications and capabilities the study requires and how they fit into the larger site and patient ecosystem. Additionally, consider investing in training, virtual enablement and resources for site staff to ensure they are comfortable with tools and applications. Not only does this provide sponsors valuable feedback about future selection of applications and devices, but it also strengthens and promotes a site-centric mindset from sponsors and CROs.

4. Simplify the trial ecosystem for patients with an inclusive mindset

Patients who evaluate clinical trial participation as a therapy do not base their decision on the intervention alone. They also assess how trial design and procedures may fit into their lives, as well as the lives of their families and caregivers. Our survey on the state of the drug development industry found that patient recruitment, including patient retention and patient diversity, is the biggest pain point for biotech and biopharma companies, with 55% citing it as the top challenge faced by their organization.

To assure that your study is truly patient centric, consider multiple factors that may affect patients participating in the clinical trial, such as: number and duration of on-site visits; distance between sites and patients’ homes; and the need for patient transportation and family support (such as child care). Partially or fully decentralized visits can make participation easier for potential patients who cannot find alternative child care or take time off work. Similar to a well-rounded site engagement strategy, consider user-friendly training and support resources that help patients easily participate. At the same time, it is important not to over-engineer the protocol or over-utilize technology at the expense of accessibility for the target patient population. For example, will older adults be comfortable using tablets or biometric devices for a study, or are the demands too daunting?

In addition, sites find more success in carrying out protocol tasks when they properly communicate the potential therapeutic offering of the clinical trial to all patient populations. Sponsors should regularly evaluate whether their materials convey the significance and value of patients’ involvement with inclusive, non-biased, culturally appropriate and health-literate language.

5. Leverage partnerships to strengthen your trial

Community organizations and patient advocacy groups can expand access to care and therapies in their communities. For them, a partnership with trial sponsors and CROs offers an opportunity to open a new “road” to new therapies. For sponsors, this valuable partnership provides access to honest and patient-centric feedback. Partnerships also enable trial organizers to tap into supportive resources, such as transportation to study visits, which can broaden the pool of potential participants for a study. Ultimately, an investment in relationships that enhance community health access will create long-lasting collaboration among sites, patients, sponsors and CROs well into the future.

Another critical partnership is between CROs and stakeholders (e.g., sponsors, patient organizations, vendors). CROs serve multiple clients and hundreds of clinical trials, and can deliver a deep and dedicated base of knowledge and experience to draw from throughout the planning and execution of a trial. Do you want to know precisely what does and does not work in a trial, pertaining to a particular indication? Tap into the expertise, tools and networks of your CRO. An ideal partnership model with a CRO incorporates shared values, governance, and honest and transparent early engagement to prioritize and co-manage the sponsor’s pipeline.

 Even as the clinical trial ecosystem becomes increasingly complex, experienced trial partners can provide valuable guidance to set your study apart from the beginning.

The expanding clinical trial landscape is promising for the development of lifesaving therapies. And new strategies and technologies—such as adaptive trial design and the use of real-world data and evidence to complement clinical trial data—offer exciting methods for trial organizers and administrators to advance the future of medicine.

However, with so many trials competing to enroll participants and navigate similar timelines, the rapid increase in research has created a daunting, constantly changing reality for those looking to claim space in the field.

Within this crowded ecosystem, leveraging the right input, data, tools, capabilities, and partnerships will position your trial for success.

, MD, MS, Vice President, Sites and Patients Center of Excellence, and 

, Vice President, Head of Development Operations-Biopharma; both PPD Clinical Research, Thermo Fisher Scientific

Number of clinical trials by year, location, disease and phase

. (2022, February). Www.who.int; World Health Organization. 

https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-trial-registrations-by-year-location-disease-and-phase-of-development

Desai, M. (2020). Recruitment and retention of participants in clinical studies: Critical issues and challenges. 

Buchanan, D. A., Goldstein, J., Pfalzer, A. C., Lin, Y.-C., Kang, H., & Claassen, D. O. (2021). Empowering the Clinical Research Coordinator in Academic Medical Centers. 

Mayo Clinic Proceedings: Innovations, Quality & Outcomes

https://doi.org/10.1016/j.mayocpiqo.2020.09.014

Goodlett, D., Hung, A., Feriozzi, A., Lu, H., Bekelman, J. E., & Mullins, C. D. (2020). Site engagement for multi-site clinical trials. 

Contemporary Clinical Trials Communications

https://doi.org/10.1016/j.conctc.2020.100608

Vat, L. E., Finlay, T., Jan Schuitmaker‐Warnaar, T., Fahy, N., Robinson, P., Boudes, M., Diaz, A., Ferrer, E., Hivert, V., Purman, G., Kürzinger, M., Kroes, R. A., Hey, C., & Broerse, J. E. W. (2019). Evaluating the “return on patient engagement initiatives” in medicines research and development: A literature review. 

Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

Trends in Pharmaceuticals Research and Development

Closing the Gap on Clinical Tech for Sites

https://myscrs.org/resources/sites-now/closing-the-gap-on-clinical-tech-for-sites

The Growing Role of CROs in Clinical Trials

https://www.ppd.com/blog/growing-role-of-contract-research-organizations-in-clinical-trials/

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A more crowded space is presenting new challenges for stakeholders that must be addressed to improve efficiency.

Matt Latey

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Make Your Clinical Trial a Priority in a Busy Landscape