Big Pharma’s R&D is a daily focus and their huge pipeline requires careful consideration. This includes, of course, the clinical research section. In fact, even Big Pharma relies on Clinical Research Organisations (CRO) to run their clinical trials – at least in part. In the last few months, I spent a lot of time speaking to Country Heads of Clinical Operations departments working for companies like Novartis, AstraZeneca, Bayer, AbbVie, etc. No matter the extent to which their clinical research is outsourced, one point remains the same:
Big Pharma companies always invest additional time and money into their clinical trial planning – independently from the CROs
You might ask yourself the same question I did:
Why would you outsource your clinical trial to a vendor if you do not even trust their initial assessment and/or planning process?
The answer is, unfortunately and as always, not as straightforward as we would like it to be. Let me summarise two main points.
1. Average Recruitment Rate (ARR):
Historical recruitment rates from comparable, completed clinical trials are probably the most powerful metric to receive a ‘green light’. In fact, this is not just a number – it provides you layered insight into the expected speed of patient enrollment, and is a strong indicator for your country selection.
CROs and sponsors, however, differ in their belief which is the best way to calculate ARR. CROs usually use the data provided by CT.gov to calculate every single clinical trial’s ARR. Their feasibility experts consider eligibility criteria to select the most relevant trials for a close assessment and prediction of the recruitment speed. Nonetheless, this assessment is trial-specific, but there might be sites and/or countries, which perform much better than others.
Pharma would rather see:
- ARR per site for a similar clinical trial
- ARR per country based on similar clinical trials
Picture: An example of country-specific ARR by TrialHub
Some of the big-size CROs, such as IQVIA, Covance, etc. have their internal databases for additional, more precise calculations, however, this again depends on their experience in a specific field. Probably the closest to actual ARR are local, specialized CROs, that have close ties to sites, and are experts in a therapeutic area – they are able to quickly assess if a study might be interesting for patients. The downside is that they are stronger in early phase clinical research, or as a local partner than managing international late-phase clinical trials.
2. CROs have or don’t have internal capacities as well.
The best scenario is managing a clinical trial in which you have local staff that knows the landscape. The proposal managers from CROs have to consider their capacity and capability before submitting their offer to the sponsor. Even if, for example, Poland is the most prosperous-looking country for a particular clinical trial, the CROs might suggest another one, just because their staff is overwhelmed and there are other countries where things are looser.
Pharma companies on the other side base their decisions about the location on the questions below:
- In which markets do I want to sell my drug first?
- Where do I have the best chance for my trial to stay on time and within budget?
This article is, of course, a general summary based on conversations I had with Clinical Operations professionals. There are, by all means, more scenarios that justify trust in the CRO’s feasibility process. At the end of the day, the clinical research outsourcing business relies on credibility and success in order to grow and be awarded more projects. This adds pressure for CROs to constantly find new ways to answer sponsors’ requirements and be on top of innovation.
If you are interested in how feasibility research works in pharma companies, you can have a look at one of my previous articles (Why AstraZeneca and Novartis Are Reshaping Their Clinical Trials Feasibility Process?) and I will be happy to hear about your experience too.