Looking ahead at 2018 and beyond, there are several shifts in clinical trial outsourcing trends that Sponsors and vendors should be aware of. Many of these trends are driven by regulations and industry guidelines as well as a growing need for new therapies.
In 2017 there was a slight increase in clinical outsourcing penetration as it grew from 43 percent to 45 percent (Clinical Leader). While the majority of outsourcing still lies with large, full service CROs, the percentage of work going to specialist CROs is growing due to a need for experts in therapeutic areas and indications, regulatory requirements and pharmacovigilance.
As for 2018, technology and eClinical are hot topics for most clinical trial Sponsors as they look to comply with guidelines such as ICH GCP E6(R2) which requires a risk-based approach to trials. Trends in outsourcing point to a bigger emphasis on eClinical solutions for data services.
Below is a look at 10 trends in outsourcing that will shape 2018:
Sure, technology has been an ongoing trend in clinical trials for years. Technologies such as Electronic Data Capture (EDC), Patient Recorded Outcomes (PRO) and Clinical Trial Management Systems (CTMS) have become the norm, however technology is now playing a fundamental role in the overall clinical study strategy. Tech giants such as Google, Amazon and Apple are also looking for a chunk of the clinical trial sector by developing technologies that focus on patient centricity. Market leaders such as Medidata, Oracle and Veeva are continuing to develop extensive technology platforms for clinical trials.
Higher quality standards
Regulations are focusing on increasing patient safety and raising the bar when it comes to Quality Management Systems and overall quality assurance practices. The ICH GCP E6(R2) guidelines suggest taking a risk-based approach to quality assurance by following ISO norms and implementing best practices. Companies will be looking for niche, specialist providers in this area.
Data privacy, transparency and anonymization
2018 will be all about protecting citizen privacy. The European Union has taken critical steps to ensuring data privacy via the General Data Protection Regulation (GDPR) which applies to all companies managing data within the EU. The European Union is also set to implement Clinical Trial Regulation 536/2014 which calls for an EU portal publishing clinical study results once a Marketing Authorization Application (MAA) has been submitted. This calls for the removal of patient identifiers and the de-identification of data.
Understanding regulatory requirements and budgeting for support
In addition to GDPR and Clinical Trial Regulation 536/2014, there are many other significant regulations set to take effect especially in the areas of clinical data management, pharmacovigilance reporting, regulatory submissions and medical device trials. Fines can be severe for non-compliance and therefore Sponsors should budget for the extra regulatory support.
Data Analytics are fundamental
Centralized statistical monitoring is being mentioned more frequently as Sponsors look to facilitate risk-based monitoring with real-time, accurate metrics. Data analytics will play an even greater role in crucial strategic decisions for Sponsors.
The ICH GCP E6(R2) guidelines place a huge emphasis on oversight and lay the responsibility of clinical trial conduct on the Sponsor. This means Sponsors are looking for an efficient means of vendor oversight when it comes to metrics, deliverables and quality.
Pharmacovigilance outsourcing (PVO) on the rise
Pharmacovigilance Outsourcing is getting its own acronym and some attention in 2018. The management and reporting of adverse events is becoming a complex business and new regulations are making it more difficult for Sponsors to keep up without support from specialized experts. In Europe, for example, there are new changes to the Eudravigilance system for the reporting of adverse events.
Medical Device regulations
The EMA and FDA have both looked at medical device trials in the past year, and the FDA is looking at the pathway for medical device approvals. The EU set forth a new framework for medical device trials including an EU-wide coordinated procedure for multi-centre investigations and improved transparency. Medical device companies need to look at how they are managing data.
Biotech going at it alone?
Biotechs have often looked to large pharma partnerships to carry their compounds into late phase trials and on to approval. Biotechs now have multiple outsourcing models available including Functional Service Provision to allow them continue developing their product.
Rise of strategic partnership model and FSP
Over 60 percent of Sponsors have started outsourcing in-house activities to “strategic partners”. For clinical, data, regulatory and clinical IT solutions, Sponsors are increasingly looking to the Functional Service Provision model.
If you are evaluating providers for your upcoming pipeline, send an RFI request to CROS NT. Specialized in biometrics, CROS NT also provides a portfolio of eClinical technologies, clinical and regulatory services and a 5-point Sustainable Quality model for FSP.