Tuesday, November 27, 2012

Topic 18 – Site Payments in Phase 4 Clinical Trials

(Full Disclosure – I was introduced to this issue by my client who has a interest in the solution to the problem but regardless I believe this to be a real problem. )

As P4 clinical trials grow larger and more complex, the challenge of site payment computation and accrual grows as an issue.

As more and more sites become sophisticated partners in clinical trials they are demanding customized contracts with payment terms associated with their work and cash flow needs.  It is hard to blame them when pharma and CROs has been so bad about paying, many times paying sites over 90 days after the site incurs the cost and paying inaccurately.

Payments are a source of friction with PIs and thus KOLs.

CenterWatch has identified late payments as the #1 site concern about pharma for the last three years. For a P4 study, Principle Investigators (PIs) are often key opinion leaders (KOLs), since many of KOLs have access to the type of patients needed for the trial.  Developing a strong scientific dialog with KOLs is a fundamental role of MA.  Yet, at the same time we are working so hard to establish a positive working environment to collaborate with KOLs, we are also degrading that relationship due to late or inaccurate study payments.

It is not at all unusual for an MSL to receive complaints about late payments on trials, even though the company has outsourced the trial to a CRO for payments.  The PIs will hold the company responsible despite the CRO’s involvement.

Payments are a source of regulatory risk.

Since payments are generally computed manually even by most CROs, many mistakes are made.  Thus at the end of each study there is a process called “End of Trial Reconciliation” when the actual amounts owed are computed against the final data collected.  Any missing money (and there is often hundreds of thousands in overdue money) is paid at this point.

BUT, the regulatory risk is not in delayed payment.  The regulatory risk is what happens if we find we have paid too much.  This happens often in clinical trials because due patients drop out but due to computational errors the site still receives payments for that patient.  If that occurs we have overpaid the site and the PI (which we discussed are also KOLs).  But this computation error may be from years before.

Now the quandary is – do we demand repayment from the site for our error.  Technically, the site should refund the overpayment.  But, I would ask your operations group if you have ever asked for that money back.  My practical experience is that the overpayments are rarely if ever collected back.  If they are not collected back, we have essentially paid more for the trial than fair market value and thus we have a potential compliance issues.

While this issue has not been one I have seen enforced to date, given the growing scrutiny on all payments to physicians with the Sunshine Act, I think it would be wise to ensure that this risk is avoided.

Payment computation is a hidden cost. 

With these more sophisticated contracts comes the need to administer them and compute payments.  Sites don’t send an invoice.  So, determining the amount to pay is left up completely to the pharma company.  Performing that computation can be complex and time consuming.

Since many pharma companies outsource their P4 trials, what they are doing is paying the CRO to perform this computation for them.  In some larger P4 trials, hundreds of thousands of dollars in fees are spent for the CRO to compute and issue payments.

New solutions are available.

The good news is that a new type of software is being developed to automate the payment process and avoid the need to do any manual calculations.  If you are interested check them out .  My client is www.clinverse.com.  Also their competitor is www.greenphire.com.

What has been your experience with P4 site payments?  Leave your thoughts in the comments.

Thursday, November 8, 2012

QuickNote: The Sunshine Act is Here to Stay!

Given the results of the presidential election, the remaining hopes I have heard expressed that the Sunshine Act would not be implemented should have evaporated.

We have already discussed here some immediate work MA needs to do to start prepping the ground for the data.  While it is looking likely that implementation may be delayed, MA leaders should be planning for this in their 2013 budgets.

Any other impacts of the election that MA leaders should consider?  Leave your thoughts in the comments.

Thursday, November 1, 2012

Topic 17 – New MA Organization – MedComm/SciComm

A reader and I discussed her dilemma the other day.  She was being tapped to create a new MA function for a small biotech that was bringing its first product to market.  She had fairly broad latitude but was not sure where to begin.  Some of the points of our discussion are captured below.

We have already discussed preparing an MA team for launch here, the effective way to manage MSL groups here  and the best way to develop a MedInfo function here, I thought I would focus on the Medical Communications or Scientific Communication group with this post.  A note about function names.  I very much prefer the term Scientific Communication because it more correctly reflects the role of the function which is to provide scientific data to the market place some of which is purely medical but some of which may be of a health economic nature that are not purely medical.

SciComm is a critical function for MA but developing one from scratch is as much a challenge in internal politics as a challenge in terms of operations.  At a small company, before there is a SciComm group the company is already publishing.  So, developing a group can be sensitive and many toes can be treaded upon if one is not careful.  The best approach is to co-opt the staff that have been driving the publication efforts in designing (and maybe leading) the new SciComm function.  But, it is critical that everyone involved realize that publications take on a broader role in SciComm than they did in CD.

In CD the role of publication was primarily focused on the results of clinical trials.  That continues to be a responsibility of SciComm but its role of sharing scientific data expands to identifying the scientific questions that the marketplace needs answered, some of which will be answered through literature analysis or through non-clinical studies.

Given that CD is typically handling the publications in advance of the SciComm function, the temptation may be to put developing the group on the back burner until other MA functions have been more fully developed.  This would be a mistake.  SciComm needs to be analyzing the scientific needs of the HCP community and ensuring that the required scientific information is available concurrently with launch.  Any delays can result in a vacuum of information and who knows what will fill that vacuum (or which competitors will try to fill that vacuum).  So, at least 18 months prior to the launch the SciComm group should be launched, right along side the MSL function.

What has been your experience with SciComm groups at launch?  Leave a comment.