Who's Driving the Study Selection Process?

Would you agree to buy a car without knowing the cost and, worse yet, without enough information to know whether you can afford the terms of the car loan? The idea of doing something like that surely must sound ludicrous to you. Yet a scenario much like this occurs every day in the clinical study selection process involving sites and their business partners.Let's review how this process typically happens now.

Clinical research sites receive an informal inquiry such as a fax or e-mail asking if they'd be interested and able in conducting an upcoming clinical study. The contact more times then not perpetuated by the site being in a database and seldom on a preexisting relationship. At this point, information shared with the site is sparse at best.

Sites sign a confidentiality agreement and then a little more information is forthcoming. On that, they are expected to make a decision... but rarely is it enough information to make an informed decision. So most sites agree it's best to usually say yes and continue to gather more information.

Then the site selection ball gets rolling and gathering speed quickly. Hopefully a pre site visit occurs with a full protocol in place and intelligent questions can be asked and the protocol discussed in depth. Unfortunately it doesn't always occur that way. Sponsors, CROs and sites begin to invest time and money and neither a final protocol nor financial information is shared with the site. During pre site visits the sites are often told the budget is managed by another department and I'm just here to evaluate the site. Before you know it, travel arrangements are being made for attendance at an Investigator's meeting by two site staff often with critical information still pending.

Sound familiar? Sure it does. Just this week, a site asked me if they could negotiate compensated for amendments because there were asked to submit the regulatory documents quickly and then there were three amendments before the site initiation occurred. I asked what the contract said pertaining to amendments and I learned the site had not even negotiated a per-subject budget and study budget yet.

Shocking... but not so much if we're honest with ourselves. No matter how often I encounter this scenario - and I see it all the time - it continues to amaze me. It amazes me both that sites are expected to make a decision about study participation without a final protocol or per patient reimbursement and that sites accept studies without a full understanding of every element of the protocol and budget terms before making commitments.

Not only does this happen every day, but it also seems to be an acceptable practice.

Let's Get Behind the Wheel!

I don't know about you, but I'd rather drive the study selection process in a more purposeful and professional manner. Unlike that mystery car purchase from above, I want sufficient and relevant information before I drive it off the lot. In doing so I can assure the word (or contract I'm about to sign has merit) i.e. I can meet the enrollment goal!

At the Site Solutions Summit in 2009, sites identified items that are "critical to know" and "nice to know" when considering a study (see details below in the sidebar). No surprise the final inclusion/exclusion criteria are the greatest concern. Right behind that criteria is the need to know the per-subject reimbursement to the site. However, this information is almost never available to the site. Why? If you're out looking to purchase services and partner with sites to conduct a study, is it not only reasonable but critical for sites to know the remuneration they can expect for each subject enrolled as well as the inclusion/exclusion criteria?

I propose giving a collegial "heads up" to those who place and accept studies. Sites from the Site Solutions Summit, as well as other stellar business partners, think it is reasonable to know and will be asking poignant questions pertaining to multiple aspects of study selection before making a final decision about their ability to conduct a study. It may be during the initial conversation or at a minimum during the pre-site visit. And isn't that what you really want? A site partner that thinks enough about the various elements that they must address before committing to your study?

In 2010 it's time to implement a new process of study site selection.

Sponsors/CROs: Do everything you can to ensure that critical information is available to sites during the initial inquiry so an informed decision about which studies to accept and which to pass on can occur.

Sites: Don't be afraid to drive! Ask for the details you need to make smart business decisions about studies that come your way.

The only way we can hope to change the current metric where 70% of sites enroll zero or fail to meet their enrollment goal, is to work together and in this case working together means sharing information early for an informed decision to be made by the sites. What do you expect is reasonable for a site to know before making a decision about study participation?

- Christine Pierre, RxTrials

[From Above]
Critical to know when considering a study:

Final Inclusion/Exclusion criteria 96%
Per subject payment 68%
Enrollment goal 61%
Rescue or add on status 60%
Gut reaction 54%
Complete protocol 53%
Past metrics/similar study 50%

Nice to know when considering a study:

Sponsor 58%
Study start date 57%
CRO 56%
IRB 55%
Who provides the source docs 55%
Expected screen failure rate 54%
Paper or electronic CRF 49%

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