Clinical Research Organizations (CRO) are the go-to partner for helping biotech and pharma companies to research, evaluate and launch their new brilliant idea of a novel compound or medical device. And in fact, the CRO market has been growing in the last few years and is expected to reach $44bln by 2021.
You can see more details in the picture below (taken from www.outsourcing-pharma.com)
This ongoing trend is to be expected, as 58% of the development costs (according to EFPIA) of a new medical product are related to clinical trials. Just a few of the biotech and pharma companies have sufficient human and data resources to conduct trials in-house. In recent interviews with country clinical trial managers from big pharma companies like Novartis, Bayer, and Roche, I was told that even the big players prefer to outsource a good share of their research.
The advantage of working with CROs for small and mid-size companies is obvious:
“CRO’s have the expertise, better capabilities and can help with FDA/EMA approval.”
CRO’s past experience is one of the big selling points that sponsors look at, as mentioned in my previous article on request-for-proposals and their hit rate. Another focus of interest is the Key Opinion Leader (KOL). However, there are three other crucial factors that influence the success of a clinical trial that are often forgotten by the sponsor, but considered by CROs:
Clinical Trial Competition – All Phases
Country selection is also influenced by the level of clinical trial competition. However, there is a discrepancy in the understanding between CROs and sponsor companies. Biotech and pharma companies often only consider studies in the same phase and region/country. Feasibility managers from CROs always consider each study: “No matter which phase, they are all targeting the same audience of patients”.
NB! By the way, you can check your clinical trial competition here.
Past Country Experience
Besides their own experience, CROs carefully perform an in-depth analysis of previous, similar clinical trials on a country, city and whenever possible sites’ level. Why is this so important? This is important because it helps CROs identify patterns and predict clinical trial outcomes. As an example, being aware of the fact that in the last 3 years every phase lll trial for Crohn’s disease in a specific country faced serious patient recruitment delays would alert you that you might expect the same problem. It will allow you to consider mitigation strategies early on, or even reconsider your country selection.
Additionally, the past country/sites experience provides an opportunity to identify sites with previous experience currently not involved in any conflicting study.
Average Recruitment Rate (ARR)
This term might be new for most people, however, if you are from the CRO industry it is definitely not. This indicator comes alongside the Past Country Experience. It is extrapolated data and might in fact not be the best way to measure your future trial success. Yet many feasibility managers consider it a good starting point to predict patient recruitment speed and timelines (which is in fact what the sponsor expects). Of course, the ARR is a starting point and will normally be combined with site-specific information, however, in case of a request-for-proposal due in a couple of days (which is mostly the case), it might not be that easy to deliver a complete assessment.
Certainly, some sponsors are internally researching such information to carefully select the most promising and beneficial country for their clinical trial. Yet let’s not forget that most pharma and biotech companies do not have the time for such in-depth research, or consider these factors as details while they are busy fundraising for the next phase.
These and other details, however, make the CRO the experts that they are and ensure their business growth. Investing in improving trial outcome predictions will differentiate one CRO from the other, and indeed, access to more data with the capability of meaningful data extraction and analysis is not only a trend ((Quintiles – IMS merger, INC Research – InVentiv Health deal, etc.), but a must for an industry where 9 out of 10 clinical trials fail (Forbes).