A common trend in the drug development industry is to utilize data and innovation to safely begin participant involvement earlier and earlier in clinical trials. As innovation continues to be generated by small biotech and pharma start-ups there are also economic reasons why innovators want to get participants into trials earlier. Many small innovators don’t plan on commercializing their products, but rather partnering with or licensing to a large pharmaceutical company at the peak of product value prior to performing expensive Phase III clinical trials. Pharmaceutical companies place value on seeing, if not efficacy signals, at least pharmacokinetic and pharmacodynamics (PK/PD) signals as early as possible. Hence, you have small innovators, driving an increased volume of participant work into phase I of testing. Call it Phase I, call it Ib, call it IIa, it all drives access to participants.
Traditionally Contract Research Organizations (CROs) have possessed full service networks that focused on performing Phase I trials in healthy normal volunteers (HNVs) in their own units. The trend to perform participant trials more frequently in Phase I has led the large CROs to adapt their model, allowing them access to a network of sites capable of recruiting the needed participant populations. Hence, they could offer their “wrap around” CRO services and utilize multiple third party clinical pharmacology units to recruit the participants and perform the clinical portion of the study. In theory the model makes sense. In reality it was less than perfect. CROs would sometimes assist in writing protocols with sponsors that may or may not have been “recruitable” because the CRO may or may not have consulted the units prior to the study being authorized. This often resulted in delays in recruitment, costly study amendments, and participant/subject dissatisfaction. Sites were often blind-sided by protocols that came in at the last minute with timelines promised to the sponsor by the CRO that could not be met because of a lack of planning between the CRO and the pharmacology units.
Enter the reality of today: The entrance into the market of specialty CROs that offer full services, recruit HNVs as needed, and recruit their own participants at their own sites. CROs that have links to healthcare providers and have set up unique relationships are better positioned to design implementable and recruitable clinical trials. If trial size makes it advantageous for specialty CROs to collaborate with third party sites, the specialty CROs have in-house medical and operational experience to help make that happen more effectively and at a higher level of quality.
If a specialty, full-service CRO writes the protocol with a sponsor, the study is more likely to get off the ground faster and may have a higher probability of success because the site performing the study was involved in its design. Look for specialty CROs that can provide insights from medical and operational professionals in the therapeutic area you need, and that have a track record of success in that area.
-Kevin Goudreau, V.P. Strategy and Growth