A new survey reveals the most important elements for a successful partnership between pharma and clinical research organisations
As evidenced at the recent SCOPE Summit 2017, pharmaceutical companies are striving to build productive, collaborative relationships with their contract research organisations (CROs). CMOs, VPs of clinical operations and data management teams realise it’s a complex collaboration founded on a mutual objective of a high-quality clinical trial result.
In Comprehend’s recent CRO Oversight Benchmark Survey, 90 percent of sponsors said they planned to increase their use of CROs in the next year. However, only 22 percent of them were confident that their CROs could hit milestones on time with a quality result. This year, 80 percent anticipate significant process changes to govern their CROs.
When we asked the ClinOps leaders about the CRO-related risks that keep them up at night, the number-one response was missed milestones, followed by data quality. Asked a second way about why CRO oversight is a priority, the same focus areas topped the responses. Ultimately, the message is clear: CRO oversight is to deliver both speed and quality. To increase speed and quality, sponsors identified three critical elements as best practice:
- Contractually document study performance metrics in a Quality Agreement
- Add guidelines to act and measure outlined in an Oversight Plan
- Automate the quality agreement and oversight plan with continuous monitoring and proactive issue resolution to facilitate Real Time Oversight.
Quality Agreement: “The what”
Sponsors often comment that the most successful Pharma-CRO relationships are aligned with shared goals and metrics. In the CRO Oversight Survey, we asked “What metrics do you need to improve to increase speed to a quality result?” The responses were fairly consistent.
The survey respondents indicated a focus on three core CRO oversight processes:
- Response is measuring subject enrollment, including management of each stage from screening to completion. The questions they want answers to include: Why is enrolment lagging? Which sites have been active the longest with the lowest enrolment rate? How is that affecting enrolment actuals versus plans? Do we need to close sites or increase investment in key regions?
- Focus area is measuring subject compliance, including management of protocol deviations, adverse events and subject visit compliance. Respondents are looking for answers to: Where are the risks? Is the increasing protocol deviation rate across sites or specific to a region or set of sites? Do we need to retrain sites and amend the protocol?
- Focus area is measuring site productivity including management of query, data entry and query resolution rates. ClinOps leaders are asking: Which sites generate higher than expected queries? Does increased site contact frequency reduce outstanding queries? What CRFs have the most queries?
The goal of the oversight planning is for sponsors and CROs to agree on both study metrics and metric oversight processes. As a critical element of oversight, 78 percent of respondents placed the highest priority on establishing a CRO oversight plan. These are slowly becoming a form of gold standard to structure and set expectations between parties. It goes without saying, in the execution stage of the trial, both the planned metrics and progress against the metrics are to be visible to all stakeholders throughout the study.
Oversight Plan: “The how”
The CRO Oversight Plan is a guideline for the ClinOps Vendor Managers that ensures the vendor’s adherence to the Scope of Work (SOW), study-speciﬁc plans, processes, procedures, and GCP guidelines. The Vendor Managers are the sponsor’s primary contacts and are responsible for monitoring the vendor’s performance including timelines, milestones, quality, deliverables and ﬁnancial adherence. Although sponsors may delegate clinical trial activities and functions to vendors, the sponsor is ultimately accountable and will perform oversight of the clinical activities and functions. Our discussion with sponsors on the key pieces of an oversight plan include the frequency and process steps for monitoring key performance indicators, identification and management of issues and then escalation where required. Best practice oversight plans include system and data access requirements. This is typically presented as a data transfer agreement. Sponsors ensure data transfer agreements include the data transfer type, integrating systems, format, delivery method, and frequency.
With well thought out and agreed upon quality agreements and oversight plans sponsors identified the next step to success was automation. They agree that automation was critical to adhere to the ICH E6 (R2) addendum and a key component of their Quality Management System (QMS) approach. Automation of quality agreements and oversight plans enables sponsors and CROs to focus on what matters and act more quickly to address issues and assign responsibilities across both the sponsor and the CRO teams.
The following are the top four requirements that survey respondents identified as best practice to achieve real-time oversight:
- Data transparency: cross-system, cross-study and cross CRO insights
- Proactive investigation: access to real-time KPIs and analytics for outlier identification and course correction
- Trusted partnership facilitation: integrated collaboration tools for efficient issue resolution
- Compliance: full audit trail.
With real-time oversight, the automation of even a basic quality agreement and oversight plan enables sponsors to hold their CROs accountable. With automation, sponsors can look across trials and optimise their operations.
The future is promising
Increasing use of CROs and the ICH E6 (R2) addendum is highlighting the need and focus around Sponsor/CRO relationships. Best Practice approach to CRO oversight is Clinical Intelligence: providing continuous visibility into CRO performance, real-time investigation and collaboration. Sponsors can now answer critical questions such as: “Are my CROs doing what I hired them to do?” “Are they adhering to the quality plan?” “What issues should we be escalating?”
With Clinical Intelligence, clinical executives, ClinOps teams, study managers and their CROs are now focusing on what matters and acting faster. The net result is the reduction in study overruns, achievement of milestones, and return of sites to within risk threshold. Clinical Intelligence provides the CRO oversight and collaboration needed to deliver speed to quality results.
Rick Morrison is CEO of Comprehend