What can clinical research organizations and their partners change in order to better support the demand for proof of value?
Well, my guess is that successful clinical research organizations are already gearing up for a lot of this. They really need to be able to assess the comparative agents in these studies so that you have not only drugs from the company, but also the drug you want to compare it with. You’ve got to be able to recruit large-scale numbers of patients. You’re not talking about studies with just two or three hundred people. You’re talking about thousands.
So, you’ve got to have an organization that can recruit these numbers of patients in a timely fashion. And my guess is that there is intense competition out there. The major pharmaceutical companies are going to competitively bid out these trials. A CRO has to have a pretty cost effective procedure in order to successfully win out on these deals.
More than ever before it has become crucial for manufacturers to prove the value of drugs today. Why is it so and what does proving that value entail?
John: I would say that, yes. But it depends on the disease. So, for example, let’s talk about kidney cancer as an example. There are drugs out there to treat kidney cancer, but they are not 100% successful. There is occasionally a relapse on these therapies. So, you could envision a company coming up with a new drug to treat kidney cancer and you’ve got to give it a comparison to a sustained therapy. But for a study like that, you don’t have to run it for years. Depending on the nature of the patient population you may have to run it for six months to a year. And you wouldn’t need tens of thousands of patients. You would only need a small number of patients.
So, a lot of this, Marc, would really depend upon the nature of the trial and the nature of the disease and what you’re trying to prove. I wouldn’t say that it all would go to the large players. There is room, I think, for everybody depending on your expertise, capabilities and what you can bring to the company that is sponsoring the clinical trial.
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John LaMattina will be the moderator for the Wall Street State of the Industry Address: Mergers
& Acquisitions in the Industry — Near Term Solution to a Long Term Problem? featuring panelists including Colin Shannon, President, CEO and Director, PRA International; Michael Martorelli, Director, Fairmount Partners; Eric Coldwell, Managing Director, Robert W. Baird & Co.; and Douglas Tsao, MPH, U.S. Specialty Pharmaceuticals & CROs, Barclays Equity Research. Would you like to join John for this panel at Partnerships in Clinical Trials this coming March 30-April 2, 2014? As a reader of this blog, when you register to join us and mention code XP1900BLOG, you're eligible to save $100 off the current rate!