You might be wondering what is the common thing between Clinical Research Organizations and school students. Well, they all have homework and exams just in a different format.
Thanks to TrialHub, my team and I are putting a lot of effort toward supporting the growth of CROs and in the last one year, we learned so much about their interaction with sponsors. It’s amazing how the qualification process for a CRO hasn’t changed much since the beginning of their existence.
It’s all about the Request-for-Proposal and their Bid Defense performance which gives Yes or No to a contract. During this process the CROs are being examined on how well they have prepared their “homework”, a.k.a run a feasibility and site assessment on the protocol.
This usually means they have a maximum of 10 days to create a proposal going through all the traditional types of information (where the patients are, sites, and competition) and preparing a high-level budget.
This is great! And I am sure, my dear sponsors, this gives you great access to free information from how many CROs you decide to approach. So, what is the challenge then?
Expecting them to prepare their “homework”, especially in a short period of time, is like examining them who’s best at manual research on Google, quicker with getting trial information from ct.gov, and more creative when creating maps and charts on Powerpoint.
If you are communicating with some of the big CROs, they might have a sophisticated platform in place to help automate feasibility requests and get more data quicker. This means they will seem more prepared, yet this doesn’t always mean:
- This is the CRO that can run your clinical trial successfully.
- They have the capacity and experience to do so.
- You can feel like they’re an extension of your team – there is a cultural fit too.
To get these answers you need to ask for a different “homework”, one that requires more time to establish a relationship and to brainstorm together what makes the most sense for a given protocol.
There is another challenge here that applies to all outsourcing industries. Usually, the client wants the best quality for the lowest price. I hope by now most of you are convinced that this is not possible – quality has its price unless you found a technological solution to help you scale your services/ processes.
Feasibility means work for free from the people in the CRO business and these people are afraid of the so-called unbillable hours. Especially public companies that are closely monitored for how much time they spend on unbillable hours and every employee is being constantly reminded.
How come, sponsors, you expect to get a real quality feasibility assessment and that way to meet the “love” of your clinical trial? It’s going to be hard. I have a few suggestions for the industry:
- Try to focus your RFP request on data on the historical experience of the CRO, their capacity, and overall pricing;
- Once you’ve identified the companies that you believe have the most solid background (country-wise, research-wise, regulation-wise whatever is important to you) go the next step: Ask them to assess your protocol, but think of paying for this service even a minimum amount.
- Maybe you should also rethink the time you spend on protocol development, feasibility, site selection, and patient recruitment planning because:
“Lack of critical thinking in Feasibility is what breaks Patient Recruitment.”
You need to not only ask the right questions but also rationalize the answers.
And let’s face it: As a sponsor planning a clinical trial, you are going to spend a lot of money on getting your drug/treatment/device to the next stage.
Deciding to save on the planning stage, might cause you to spend a lot more money due to delays, challenging patient recruitment, rescue country selection, rescue site selection etc. Or maybe this is exactly what happens to the 85% of trials that get delayed?