Coming Soon: ‘The Site’s Side’

Forward by: Dan Manak, Director of Business Development, goBalto, Inc.

Sites – It’s Where the Patients Are!

Ever since I left my first job out of college (late 80’s), working in an environmental organic chem. lab, I think I have been working directly with physicians and their offices.

From that lab, I went to carry a bag for Roche.  And for the next decade, spent the better part of my time selling and educating physicians on my products. To this day a more reputable and therapeutically significant product line is hard to find than the ones I’ve had the honor to represent. And the training I got at Roche – out of this world!  If nothing else, that experience taught me exactly how to do business with physicians and within healthcare communities.

As a drug rep and in running an SMO I have always had the luxury of working with the medical profession/industry directly and personally. Now, many of our readers probably feel the same way, and have excellent relationships with their sites and PIs.

I have spent the better part of my professional life negotiating and mediating between sites and sposnors/CROs. And in all those experiences, it has been very rare to come across an individual that did not understand &/or have a level of compassion for clinical research sites.

Yet…

It’s a big “yet”. Despite our individual good intentions and excellent perspective, the relationships between sponsors and clinical research sites can be distilled down to the B2B relationship between the two. And on this level, I’m afraid there can be a chasm miles wide between sponsor and site. Philosophically, I believe that sponsors and CROs have started coming around. Most would probably agree that industry has been trending for some time now, more in favor and recognition of site value.

My point is:  though the chasm seems like it may be miles wide, if we’re all philosophically aligned we may be closer than we think. There is little doubt in my mind that that information technology and software/hardware that actually work will soon revolutionize the science side of bringing new, therapeutically valuable therapies to market as well as the business side of clinical research.

We are embarking on a new blog series at goBalto, one about which we are very excited.  All along as we’ve been building Tracker we have worked closely with research sites. We’ve had site owners and PIs as bloggers. But never before have we focused a series that addresses the site side of clinical research.

I am but introducing the series. The majority of the rest will come directly from sites. To kick things off, I am including in this intro to the series a list of 19 site-specific roadblocks encountered by a real site today.

WARNING

The content you are about to view is not for the faint of heart. And if you are a less-experienced clinical study manager you may be quick to ascertain that this site might be too ‘difficult’ to work with. I feel strongly; however, that 100% of the “good sites” out there will identify with at least something on this list.

I hope that you will agree though, that the vast majority of the complaints are well within reach to rectify. Most have to do simply with smart business processes.  Admittedly, the human factor is a big component, and whenever there is a human factor there is mystery and error.

The core reasons for sites to participate in clinical research are pretty simple. Very often – it will have a lot to do with bringing value to their patients. Could be they are cutting edge thinkers and this is how they like to stay up to speed. Years ago, I believe some got into it for the money.  [I’ll pause while you stop laughing/choking.]  No doubt this alone is not a good enough reason to get into research.  But the clinical research site is where the patients are and this is where the sponsor’s “front line” is. The PIs and sites are performing a pivotal role, tantamount to the success of any potential product from which others may benefit. The involvement of research sites should include unquestionably fair compensation, and the highest degree of support.

As individuals we need to rally our respective company execs to support us through effective SOPs and new business tools & processes that will help narrow the chasm between sites and sponsors. Clinical research can be profoundly beneficial to PIs and to their patients. It is time we, as an industry, make it welcoming again to PIs and research sites.

THE LIST:

1. Monitors bring electronic copies of documents they need and then asking us to copy them all to hard-copy and bring those hard-copies to them so they can do their work… all at our cost.
2. Frequent non-optional but previously unscheduled telephone or web conferences, for amendments etc., requiring several of your staff be present, plus PI… all uncompensated.
3. Repetitive GCP and other unnecessary training, more and more lengthy, again, all uncompensated, last minute with little notice, and required of all the involved staff and sub-investigators (who are not used to being unpaid for their time. Why can’t they all decide on C.I.T.I. or other nationally recognized source of GCP training and accept that certification… even if q 6 months… as the standard requirement?
4. Monitors not looking at Reg binder at visits, but later calling and asking us to copy parts of it and send it… essentially remote monitoring saving them money but costing us.
5. Recent phone call: requiring back up investigator, not allowing a nurse practitioner, to sign in case of PI’s absence…. but requiring that that backup person perform all of the training etc., again, time-consuming and costly with no recompense to the site.
6. PI’s required to do the data entry training and be tested on it… when they will never be doing the data entry.
7. Hours spent just trying to get the passwords and to get on the websites, not only to do training but to be able to get in and break blind and sign etc.
8. IVRS systems don’t dispense drugs, have to reschedule patient, who then expects to be paid… though we are not paid for that visit.
9. Remote monitoring of SAE’s requiring us to dismantle charts, make copies of requested materials, then reassemble chart, and line out the patient identifiers on the copies made. All this then has to be faxed. Again, this is all stuff the monitor used to do at their visits.  We are saving them huge amounts on monitor visits, but they, despite these savings, are requiring a huge amount of payroll expense to the sites, all non-budgeted and therefore not reimbursed.
10. After negotiated budget, amendments often end up requiring extra work.  We have to first of all be able to identify that and get that to our business office, they then have to fight for money for these previously un-budgeted expenses.
11. SAE’s for some sponsors, require much more work with more forms than others.  Again, a budget item often met with great resistance.
12. Not being paid for company audits, when done because of high enrollment.
13. Re-issuing the same queries, which have been answered, but apparently not reviewed, over and over again.
14. Lab coming in bulk so we have to build our own lab kits, (we used to get all of these already made up in small kits).
15. Costs of i.v. fluids, syringes, needles that in the past were all supplied, now as an extra expense to the site who have to supply.  If it’s part of the protocol requirement, it should be covered in the protocol expenses.
16. EDC upgrades which lose all our previously entered data, requiring us, again for no compensation, to re-enter.
17. Training for amendment, required by all on the site signature log, whether the amendment affect their role in the protocol log or not, eg. lab personnel, blind pharmacists etc, no recompense.
18. Reg docs required through password-protected web sites that requires yearly training, even if we have been actively using at the site.
19. Continued resistance to covering costs of record storage and record retrieval.

Please note that this is not meant to be an all-inclusive or even a specific list.  It is provided as food for thought.  The goal of this series will be twofold:

1. It will highlight the roadblocks and challenges at clinical research sites.
2. It will reveal the most successful sites’ approaches to mitigating these challenges and creating success in their clinical trials and their research business.

A third, ultimate goal is for this dialogue to spin-off thoughts, ideas, conversations and action that brings sponsors and sites closer, allowing for faster, easier, safer, and more equitable execution of clinical trials.

Over the course of the coming weeks, our site bloggers will no doubt cover many of these items listed below.  As always though, whether from a site or from “the other side”, your constructive thoughts are always appreciated!

Tagged as: clinical research sites, EDC, gcp, healthcare, physicians, PI, SMO, sposnors/CROs