As part of the clinical research organization (CRO) community, providing expertise to biopharmaceutical, biotechnology, and medical device companies, PROMETRIKA is accustomed to being part of a clinical research team that includes these companies (‘sponsors’) in addition to a variety of supportive and complementary companies (‘vendors’).
A single drug requires the involvement of hundreds, sometimes thousands, of people for resources and development. Additionally, the clinical trial process can be very long; it can take upwards of 10-15 years to get a new drug to the market and available for sale to the general public. Some sponsors are not sufficiently resourced to execute clinical trials internally and solicit assistance from one or more CROs in managing their clinical trials.
A collaborative relationship between the sponsor and CRO or CROs working in parallel is imperative. The pharmaceutical industry is very competitive, not only at the sponsor level, but also at the CRO level. As a result, CROs may adopt an ‘Us versus Them’ mindset when collaborating on a clinical trial on behalf of a sponsor. Today’s trials are quite costly and coordination among several CROs can be either tremendously beneficial or can add to the expense. Effective collaboration allows for trial risks to be identified earlier (e.g., site performance, enrollment challenges, protocol deviations), thereby allowing for cross-functional insight to help mitigate issues proactively rather than reactively. Close communication among CRO collaborators is especially critical in trials with adaptive designs or those using decentralized elements (e.g., rare-disease trials).
With increased specialization available in the field (regional or country-specific regulatory knowledge, therapeutic-area specialization, advanced technology platforms/analytics, etc.), trials lasting for several years and a larger pool of competitors, it is becoming increasingly likely that each trial will have multiple vendors. When multiple CROs are involved (for example, a lead CRO plus specialty or regional CROs), effective collaboration can directly influence trial quality, speed, cost, and regulatory success.
There are several key items that CROs need to consider when aiming for successful collaborations with other CROs and vendors: work collectively rather than individually; work towards project/sponsor goals rather than individual CRO goals; practice effective communication; and most importantly, reject the competitive mindset. Teamwork is key to the success of running a clinical trial, and that teamwork should be inclusive of all team members - the sponsor team members and all CRO and other vendor team members. With over 25 years in the clinical research and development field, the most successful projects, in my mind, are those that embody teamwork. Project teams can quickly become dysfunctional when teamwork is not practiced and prioritized.
In summary, success of a clinical trial is often viewed binary in that the clinical trial either results in a new medicine or device being approved by regulatory agencies or not being approved. However, there are a great number of variables that all must work together efficiently and with a common focus in order to be able to achieve success. Multiple independent entities must come together and maintain a collaborative and productive relationship during the clinical trial process and move beyond the competitive mindset in the best interests of the sponsor, the clinical trial, and the patients awaiting these new therapies.
