One of the greatest challenges for sponsor companies seeking to complete clinical studies and gain regulatory approval for their assets is ensuring patient enrollment goals are achieved on schedule or, better yet, ahead of schedule.
Even before COVID-19, the majority of clinical trials were not meeting their patient enrollment goals. Now that we are in the middle of a worldwide pandemic, trial sponsors are faced with more challenges than ever, including hyper-competition for finite patient sets, limited ways of creating study awareness as well as logistic challenges. This cascades into difficulties enrolling and retaining patients in clinical trials in anything close to desired goals.
One way to positively impact patient recruitment goals is by developing a foundation alignment strategy and partnering with one of the many established disease area foundations or advocacy groups to advocate for the specific disease area from which your trial is seeking to draw. After all, the more targeted your patient recruitment is, the greater the study completion rates and the more successful your study (and potentially your outcomes) will be.
The foundation’s role is to continuously improve patients’ healthcare by providing information about and access to approved treatments and ongoing research opportunities within a specific disease area. In a sense, a foundation or advocacy group is a virtual repository of education and information for the community of interested patients, caregivers, and healthcare professionals to both learn about and participate in disease treatment opportunities – including clinical studies.
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The role of the foundation includes:
- Building awareness about the disease state
- Advocating for optimal healthcare
- Accelerating education, research & development
- Driving and impacting policy
- Integrating patient experience into the drug development lifecycle
- Providing patient access to and coverage for approved therapies and new studies
- Establishing interested communities within the disease state
It makes sense to identify and align with a foundation to help connect you with the targeted patients and caregivers you both seek and need. Foundations harbor thousands of interested and engaged patients, caregivers and healthcare professionals seeking better treatment options and better lives. Recent research has taught us that these patients seek to be part of the answer for the future of the disease treatment in most cases. Participating in studies and research will help them individually and help future generations of similar patients.
In fact, there is a movement among foundations to work ever more closely with R&D efforts to help them realize their missions and achieve results for their members. As a result, trial sponsors are increasingly welcomed to collaborate with these foundations.
Six Degrees has worked with sponsor companies and relevant foundations to better understand, position for, communicate to, and attract important communities. These initiatives have helped accelerate patient enrollment and retention for studies working with foundations such as Parent Project Muscular Dystrophy (for Duchenne muscular dystrophy trials) and the Foundation for Sarcoidosis Research (for pulmonary sarcoidosis trials), resulting in more directly targeted and accurate patient communication.
In these cases, the foundations were happy to post relevant and helpful information about the studies, including recruiting studies, study information, patient recruitment targeting and qualification, data sharing, site locations, and links to clinicaltrials.gov for additional trial information. These initiatives help the foundation and the sponsor companies alike by connecting patient need with therapy and research opportunities.
As you prepare your patient engagement strategies for upcoming studies, be sure to remember the role of the foundation or advocacy group. Time and again they demonstrate the ability and provide the platform for patient engagement optimization and, ultimately, hope for patients and sponsor companies alike. It’s a win-win scenario – take advantage of it!
For help with your clinical trial branding and patient recruiting needs, call us at Six Degrees.