you got a password?

A sponsor recently presented some site audit findings at an investigator meeting and I think two of them are definitely worth repeating:

1) The site has a number of personnel that were granted IVRS/EDC access, but never changed the initial passwords or accessed the system at least once.  So what's the big deal?  Well when user accounts are generated an initial password is created, which is sent either by email or fax and must be changed (by the person whose account it is) to something unique.  The sponsor is likely arguing that if an account is never fully activated or deactivated after the initial access information is sent, then that log on information could easily be abused by someone who is not supposed to have permission to access study specific files or databases.  The take home messages here are that if you have multiple users for a number of EDC/IVRS accounts, make sure that those individuals log in at least once when access is granted and if someone leaves the site (or study), contact the system administrator to have their account deactivated.
   Seems easy enough, but I imagine there are lots of situations where this situation exists at research sites.

2) Eligibility reviews.  The same sponsor noted that they are looking out for an assessment of continuing study eligibility by a qualified investigator at every visit up to (and including) randomization.  This includes washout visits, run-in visits, and screening visits.  Such a request is there to demonstrate that the site is continually monitoring subjects for eligibility and that inappropriately qualified personnel are not making decisions concerning subject eligibility.  While it may seem like more of a hassle than its worth, the eligibility assessment prior to baseline can be as simple as a statement signed by an investigator that a subject "meets all study criteria at this time."  Once that's done, you're in the clear (but of course, make sure the investigator is actually assessing eligibility...no blind signatures, please!)

Linked Up

EDC provider OmniComm has announced that it has finalized plans to link its TrialMaster EDC with an electronic medical records platform: MS HealthVault.  This plan would allow for those patients or providers using this medical records system to seamlessly upload their records to the EDC system. Sites using paper records are currently stuck in a perpetual battle with ensuring that the information they report about trial participants is accurate and up to date.  Such a connection between electronic records and EDC would eliminate the need for tedious data entry for medical history and allow for the inclusion of more detailed participant history into the trial database.  I imagine there could be all sorts of interesting trends that could be gleaned from the merger of EDC and patient records, likely going above and beyond what is possible today.

The one thing that this merger of EDC and EMR would need to recognize is that patient confidentiality has to be maintained.  There has to be some sort of mechanism to remove confidential patient identifiers from the records before transfer into the EDC system while at the same time allowing for identification of patient in the trial database (by date of birth, initials, etc).  Check out this link for more information: OmniComm

Also, in an unrelated note, I think it's worth mentioning the importance of organization for clinical trial sites.  If a site is audited one of the worst things that can happen is to have files in a state of disarray.  This will frustrate the auditor (amongst other things), and cause he/she to start looking more closely for problems.  Yes, the auditor is there to perform a detailed review of the study files, but it's in the site's best interest to make the auditor's job as easy as possible.  One of the best ways to do this is having everything in order because uniformity, clear labeling, and precise filing can do wonders for a site.  More to come on this later...

Spread the Word

The FDA has taken what I believe to be an important step to increase public awareness of what exactly the agency does by creating a section of their website called "FDA Basics."  The idea behind this website is that most people don't really know what all the FDA does and how the FDA does its job.  It looks like a work in progress, but it does have a section on "drugs," which contains some information about the drug approval process as well as enrolling in clinical trials. 

Research sites should take advantage of this resource and use it to not only inform site staff of the FDA's functions, but also present it to potential trial participants as a free educational public outreach tool.  Clinical trial sites are always struggling to find better ways to inform the public on research studies.  Often the problem is not getting word out via advertising, but rather actually educating people on how and why clinical trials work.  It's important to remember that a critical part of informed consent is the actual "informed" part, which may be detailed in descriptions about a study but could be lacking on a description of the "big picture" of clinical research.  That's where this new website from the FDA can help: it has the potential to offer information direct to participants straight from the top regulatory authority in this country.  I think that the site could stand to have more detailed clinical trial background information, but it's certainly a step in the right direction.

Feel free to share the site on your websites or in your conversations with staff and potential participants:

http://www.fda.gov/AboutFDA/Basics

return of the paper CRF?

Everyone has heard about the recession and the economy affecting almost every industry out there.  In clinical research the recession has tightened R&D budgets and made new trials harder and harder for sites to come by.  In line with this trend, sponsors are always looking for new ways to cut costs such as limiting CRA travel and taking lower bidders for study vendors.  But how about the technological revolution in clinical research?  Is its growth going to be stunted by the recession?

The main example I'm thinking of is with case report forms.  I'm thinking that some sponsors may forgo the expenses of electronic data capture such as bidding for services (those RDE companies cannot be cheap at all) in favor of more traditional paper case report forms.  Yes electronic data capture is faster, more efficient, and cleaner (no illegible handwriting), but paper case report forms are likely cheaper to implement for smaller studies even if the data takes longer to process.  I may be wrong about this, but I think it's a situation that sites should consider because most studies at this point are using some form of electronic data entry.  However I should mention that even if paper CRFs return (at least for the short term), it won't be long before they are totally obsolete.  The emergence of the entirely paperless source document is just around the corner and if you want to talk about a real game changer, that will certainly be it.

In the meantime, if you start seeing more paper CRFs come your way don't say I didn't warn you!

Pharma Audible

Fierce Biotech and the Wall Street Journal reported today on the evolution of Research & Development at Eli Lilly.  In a nutshell the pharma giant is changing the way it gets from novel molecule to blockbuster drug by outsourcing more and more of its R&D operations to CROs instead of running them in house.  On the surface, it makes sense that most huge pharma/biotech companies cannot reasonably do everything at once without tearing themselves apart, but this trend (which is mirrored by companies like Sanofi, GSK, and Pfizer) also has implications for clinical research sites.

For example with Lilly's growing investment in CROs for R&D, it is exceeding important to maintain strong relationships with CROs as they will provide valuable feedback to the study sponsor about the quality of work coming out of research sites.  If a site is a high enroller, collects clean data, has few deviations, and is generally pleasurable with which to work, then that site would likely receive a favorable recommendation from the CRO to the sponsor.  Present studies beget future studies, and the best way to ensure this continues (and that we all stay in business) is to provide high quality work with high quality customer service.  I believe that Lilly's movement towards more collaboration with CROs is a sign of the changing times, and sites must work harder than ever to ensure that a good reputation precedes them when being considered for new studies.  A good reminder of this fact comes straight from the Code of Federal Regulations that basically says if a sponsor elects to delegate certain clinical trial responsibilities to a contract research organization, then that organization assumes the role of the sponsor....keep that in mind when working with CROs...they have essentially the same authority as the sponsor itself!

Oh, and here's a few reminders about good customer service:

-Be prompt in returning voicemails and emails (every "customer" is important!)
-Act/Dress appropriately when working directly with sponsor/CRO representatives
-Respond to requests in a timely manner...this includes queries/data entry (few things please a sponsor more than fast/accurate CRF transcription)
-Be organized! (this took me a long time to figure out, but I'm glad I did!)
-Be confident, but not cocky...know your stuff, but don't flaunt it.