We all love trends; fashion trends, music trends, twitter trends, you name it. In clinical trials it is no different – we love our trends. Be it patient centricity, risk-based monitoring, digitization, adaptive trials or analytics. However, we sometimes fail to see and plan for the impact these trends can have on the way we outsource our work. Below we will look at five of the current biggest clinical trial trends and see how each may impact clinical outsourcing decisions, and potentially create trends of their own.
1) Patient Centricity
In the article from Applied Clinical Trials, A Practical Overview of Patient-Centric Trials, the idea for patient-centric clinical trials is “to lessen the burden of participation by making the participant journey as convenient and pleasant as possible.”1 What the industry will likely see in the next few years is a rise in niche vendors, rather than large full service CROs, providing more patient-centric technologies and direct to patient services. In terms of outsourcing decisions, there will likely not be a consolidation of vendors in a clinical study, but rather a rise in the number of vendors being utilized for at least a few years (until the big CRO players acquire them).
Patient centricity will also bring about faster evolution and improvement of the products, technologies and services being utilized by patients in clinical trials. This is due to the more real-time feedback culture (e.g. patients will take to social media and blogs if something is not working correctly). This will in turn create industry pressure for improvement, movement and more agility in responsiveness than ever before. Not only has patient centricity disrupted the way we design clinical trials but it will also disrupt its business and outsourcing decisions.
2) Risk-Based Monitoring
Risk-Based monitoring (RBM) is one of the biggest industry trends aimed at helping smarter data-driven decisions, risk mitigation as well as reducing overall monitoring costs. However, one of the current challenges of risk-based monitoring is being able to achieve data integration from separate sources to allow for efficient risk mitigation and decision-making.2 Although the adoption of RBM seems to be the biggest challenge, it is the integration of disparate data sources into an intelligent decision-making source that will prove whether this trend is valuable. This challenge opens an outsourcing opportunity (and a market advantage) for technology vendors and full service CROs with platforms that can effectively integrate data from multiple systems into a central decision-making tool.
3) Digitization of Clinical Trials
Like the patient-centricity trend, the digitization of clinical trials is grounded on making things easier and more enjoyable for patients. It is also like the RBM trend in that the market will call for efficient data integration platforms. However, one of the trends digital trials will generate is the outsourcing selection of vendors and CROs who can demonstrate their strength in the “PIAT Effect” or their “pulling it all together” ability for digital trials.
Digital trials will call for a strong project management component which may be kept in-house with larger sponsors, but will likely be outsourced for smaller-size organizations. Additionally, since these trials directly engage the patient, it is their voice and experience with vendors and CROs that will influence future outsourcing decisions made by the vendors.
4) Adaptive Trials
This is one of the few industry trends which seem to have strong support from those in Washington D.C., as well as the new FDA head nominee Scott Gottlieb. Mr. Gottlieb along with many in the industry see the advantages of adaptive trials to promote shorter timelines to drug approvals, and a more efficient FDA review.3 However, as the name suggests, adaptive trials are meant to be adaptable. So how does this adaptability potentially impact the way we conduct studies, and especially our outsourcing decisions? One sure thing this trend will require is flexibility.
Flexibility to ramp up and down resources, flexibility to manage changing study designs, and flexibility to respond to new drug supply requirements, just to name a few. This need for flexibility will likely influence even more outsourcing decisions made by trial sponsors to assure quick adaptation of new study designs or other study changes as needed.
The analytics trend has taken clinical trials by storm and shows no signs of abating. This trend has already created a new wave of outsourcing whereby specialized patient recruitment and retention vendors leverage predictive analytics to find sites and patients. However, another area where the analytics trend will become more prevalent is within the actual outsourcing decision-making process for pharma and biotech companies. Outsourcing decisions will be more and more powered by a vendor’s past metrics and predictive analytics of future performance.
Existing relationships and vendor/CRO discounts will only be a complimentary trait. Predictive analytics will be in the driver’s seat for clinical outsourcing decisions. Actual vendor and CRO performance will be put to the test, potentially starting a new trend to outsource work to less known or smaller vendors, and CROs who may have a smaller marketing budget, but better overall predictive performance analytics.
The reality is that every trend innately generates its own set of trends, be it in fashion music or clinical trials. The important thing is to watch, plan and to be adequately positioned to meet the needs these trends will naturally create.
Débora S. Araujo
Associate Director, Clinical Site Budgets and Payments
*The views of the article are those of the author and not necessarily those of Boehringer Ingelheim Pharmaceuticals, Inc.
Svahnvist, H. L., & Skabeev, A. (2017, March 01). A Practical Overview of Patient-Centric Trials. Retrieved October 09, 2017, from http://www.appliedclinicaltrialsonline.com/practical-overview-patient-centric-trials
Giblin, M. (2016, September 28). The Core of RBM is Centralized Monitoring. Retrieved October 09, 2017, from http://www.appliedclinicaltrialsonline.com/core-rbm-centralized-monitoring
Servick, K. (2017, April 7). Congress and FDA nominee heap love on ‘adaptive trials’. Retrieved October 09, 2017, from http://www.sciencemag.org/news/2017/04/congress-and-fda-nominee-heap-love-adaptive-trials