Lisa Henderson

Dr. Harsha Rajasimha, Founder and Chairman of IndoUSrare, discusses the emotional reason behind founding the non-profit, programs they offer that are helping rare disease parents/patients, rare disease research in India, and much more.

Podcasts

IndoUSrare: Purposeful Clinical Research For Rare Diseases In India

Dan Brenner, Founder and CEO of 1nHealth, discusses his path into clinical research and patient recruitment, the Gold Eagle Next Generation Board, what millennials/next generations want from organizations they buy from or invest in, how industry can best harness patient data to accurately predict recruitment timelines, and much more.

Patient Recruitment Strategies In A True Digital Age

In this podcast, Dr. Milligan makes the case for studying drugs in pregnant and lactating women on an ongoing basis to understand long-term efficacy and safety, as well as effects of concomitant medications on these women. Sandy believes that the entire ecosystem--regulators, policymakers, governments, physicians, healthcare systems, and industry, need to have a conversation around improving the under-met and unmet needs of women, which includes understanding the unique experiences of women with conditions such as pre-term labor, menopause or endometriosis.

Sandy Milligan, MD, JD, Head Of Research And Development, Organon

Currently, we are straddling two worlds, or more—post-pandemic, always endemic, another full-fledged pandemic? People are looking to these coming winter months with trepidation. Flu? RSV? Or COVID? It’s a toss-up.

But this confusing 2022 world impacts trends for 2023. Let’s take a look at a tiny fraction.

Telemedicine as a basis for decentralized clinical trials (DCTs)

. Telemedicine and receiving healthcare remotely was the basis of clinical trials and healthcare delivery during COVID. According to data from IQVIA, after its “dramatic entrance,” telemedicine is holding steady at 8% of all claims data through 2022. Not a decline, 

, but not a demonstration of ongoing growth. Other models of DCT visits—pharmacies, or home nurses, for example, are also not without challenges. For home nurses, it’s the consideration that some patients may not be amenable to others in their home. And large pharmacy retailers have shuttered over 700 stores in the past two years (IQVIA, September 2022).

 As DE&I initiatives and patient engagement outreach outside of urban areas continues, the “community” approach is a primary target for growth, in theory. Historically, however, that last mile from community outreach to participant enrollment is still a tricky one. Numerous ways to reach those community sites (hospitals/health systems/sites) include networks or partnerships; EMR search for potential participants; physician referral programs; and boots on the ground efforts in underrepresented population areas to amplify trust and further local engagement. Each of these is not an insignificant lift for clinical operations.

Not one presentation this fall has failed to note the decline of available professionals to staff clinical trials operations, on numerous levels and roles. At the site. At the CROs. Hospitals. Pharma. Turnover is high, and overall, the healthcare field is suffering a dearth of trained staff. This is not a 2023 problem, this is a long-term projected problem that is impacting all levels of healthcare delivery.

I didn’t intend for this column to only highlight challenging trends. But the truth is, as industry weaves its way through hybrid clinical trials and delivering on underrepresented populations for participation, there is no one way to success; it’s a complex 2023 world. 

 is Editor-in-Chief of Applied Clinical Trials. She can be reached at 

Articles

Industry straddling two worlds as new year approaches.

From Present to ‘Post’: Holdover Trends to Watch 

Jane Myles, Vice President, Clinical Trial Innovation at Curebase, discusses her current role, what led her there, and challenges their clients face with DCTs.

The Key To Innovation In Clinical Research? Listening.

Chief Science Officer at Unlearn.AI, Dave Miller, discusses digital twins, their pros and cons for the industry, and developments in Bayesian design and adaptive trials for CDER and CBER.