Financial Analysis

Follow the Money

Seeking patients in new (funded) places

By: Michael A.

Director, Fairmount Partners

It might seem obvious that the drug development organizations with the greatest access to money will be the ones that continue to fund the conduct of most clinical trials. But the times are a-changin’.

Could Pharmacies/Pharmacists Become More important — and Compensated — Drivers of Enrollment? 
An interesting survey and webinar by McKesson and CISCRP recently suggested that pharmacists may have a previously unrealized role to play in the clinical research enterprise. 
  • Although 98% of the consumer respondents said they had never asked their pharmacist about a clinical trial, 80% of them said they would want those medical professionals to tell them about any relevant trial. 
  • While 87% of the pharmacist responders believe it is very important to educate the patients/customers about clinical trial participation, only 56% would be “very willing” to provide such information if their patients/customers were interested in receiving it. However, another 34% would be “somewhat willing”. 
Based on the survey, McKesson conducted a pilot study to flesh out the role of community pharmacists, especially those operating independent pharmacies, in expanding their businesses by proactively seeking to connect their patients/customers with appropriate clinical trials. The company mapped its 2,300 pharmacies to sites to identify nearby investigators. They then identified potential clinical trial candidates using prescription claims and demographic data, asked the interested pharmacists to vet the potential candidates, used a call center to engage and screen patients on behalf of their pharmacists, and referred interested and eligible patients to the study website for further action. The 300 participating pharmacies referred 221 patients to a range of Phase III and IV studies; 161 of them (73%) enrolled. Interest seemed particularly high in post-approval studies. 

Could Disease Foundations Become More Important Drivers of Clinical Trials?
The trade press has carried reports of several recent developments at the Michael J. Fox Foundation, which funds and supports research and development for Parkinson’s Disease. 
  • A MJFF-funded study identified the best clinical rating scale for testing drugs to control the dyskinesia (uncontrolled physical movements) commonly experienced by patients with Parkinson’s.
  • The Foundation extended its online clinical trials finder to include patients and studies in the UK, Ireland and Canada. 
  • The Foundation will collaborate with Sanofi to test a new early treatment for Parkinson’s.
These are only the latest of the Foundation’s funded efforts to ameliorate Parkinson’s Disease.

Will Integrated Healthcare Systems — Including Accountable Care Organizations — Accelerate Their Involvement in Clinical Research?
The traditional division of health care treatment systems and health care insurance organizations is breaking down. The formal ACOs that are an important part of ObamaCare might not work in every geographic area. However, there is a growing belief that provider systems taking the responsibility for the financial aspects of their patients’ care (as well as the health outcomes) will be able to deliver better outcomes at lower system-wide costs. It seems only a matter of time before such systems will recognize the increased relevance, importance, and cost-effectiveness of participating in more clinical research studies. 
 
My Take 
(With Apologies to CNN’s Fareed Zakaria)
Only a tiny fraction of all the persons treated in our nation’s hospitals and physician offices each day are involved in clinical research. Pharmacists, patient care interest groups, and healthcare treatment systems with financial responsibilities for their patients’ care can all become more meaningful participants in the broad clinical research enterprise. The financial incentives to make that happen may not be as effective as they need to be right now. But in the coming months and years, I anticipate a lot more innovative thinking about how to get real patients to become more involved in clinical research. 
Michael A. Martorelli is a Director at the investment banking firm Fairmount Partners. For additional commentary on the topics covered in this column contact him at [email protected]  or at Tel: (610) 260-6232; Fax (610) 260-6285.

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