Accessing Success: What’s Next in Drug Development
Creating a patient- and site-centric approach to clinical trials
Patient diversity in clinical trials is critical to ensure that safe and effective therapies are brought to market. That said, it’s been historically difficult to achieve.
To move diversity forward, sponsors’ studies must:
- Test medicines in real-world populations to ensure the solution benefits all potential patients
- Adopt a patient- and site-centric mindset – working holistically to drive inclusive, representative clinical development, with patients at the center.
- Prepare to respond to the growing pressure from regulatory bodies.
Tap into insights on how to embrace a patient diversity mindset from Rodrigo Garcia, Vice President, Sites and Patients Center of Excellence, PPD™ clinical research business of Thermo Fisher Scientific.
Video transcript
One pressing issue and opportunity that we’re facing in the clinical trial community is to make sure that all the potential solutions that we offer have a patient, and site-centric approach. That means that these solutions need to resonate very well with those communities to secure a successful implementation and outcome for patients. One trend that I’m seeing and that will continue for sure, is the need to work closely with sponsors, CROs and vendors to make sure that we bring diverse patient populations into our clinical trials.
The recent guidance coming from the FDA has given the necessary boost of energy so sponsors, CROs, and the site and patient community work together to make sure that moving forward we can measure success and all our tools and offerings are really driven by that patient diversity mindset. I expect more transparency between the clinical research community that will help us to better understand which recruitment strategies and tactics have actually yielded the best results to bring these diversity of patients into clinical trials.
It will also give us a much needed metrics that we’re looking for that will help us to educate how we should tackle the situation in the future. What sponsors should continue to do in order to be ahead of this important issue is to work together with CROs and the site and patient community to make sure that they put together a comprehensive, long-term transformational strategy so any tactics and interventions are really having a long-term impact, instead as a “now” impact. We are approaching patient diversity with a holistic mindset. We work together with multiple functions to make sure that we provide a well integrated, a seamless solution to our clients, patients and the site community. We have to make sure we’re embedding a true patient diversity mindset in all our solutions in a seamlessly factual way.
Video transcript
One pressing issue and opportunity that we’re facing in the clinical trial community is to make sure that all the potential solutions that we offer have a patient, and site-centric approach. That means that these solutions need to resonate very well with those communities to secure a successful implementation and outcome for patients. One trend that I’m seeing and that will continue for sure, is the need to work closely with sponsors, CROs and vendors to make sure that we bring diverse patient populations into our clinical trials.
The recent guidance coming from the FDA has given the necessary boost of energy so sponsors, CROs, and the site and patient community work together to make sure that moving forward we can measure success and all our tools and offerings are really driven by that patient diversity mindset. I expect more transparency between the clinical research community that will help us to better understand which recruitment strategies and tactics have actually yielded the best results to bring these diversity of patients into clinical trials.
It will also give us a much needed metrics that we’re looking for that will help us to educate how we should tackle the situation in the future. What sponsors should continue to do in order to be ahead of this important issue is to work together with CROs and the site and patient community to make sure that they put together a comprehensive, long-term transformational strategy so any tactics and interventions are really having a long-term impact, instead as a “now” impact. We are approaching patient diversity with a holistic mindset. We work together with multiple functions to make sure that we provide a well integrated, a seamless solution to our clients, patients and the site community. We have to make sure we’re embedding a true patient diversity mindset in all our solutions in a seamlessly factual way.
What are the biggest challenges your organization is currently facing?
2022 Industry Survey
In our 2022 industry survey of more than 150 global drug development leaders, more than half (55%) said the biggest challenge facing their company was patient recruitment in clinical trials, including patient retention and population diversity.
Our comprehensive patient diversity offering embeds inclusive research solutions curated to meet your needs at every phase of drug development— early phase through post-authorization. Through proactive planning, innovative strategies and solutions, and unparalleled partnerships, you can be confident your trial will meet regulatory requirements for including clinically relevant patient populations on time and on budget.
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