Clinical News Roundup: ICH Looks To Revamp GCP Guidelines

By Ed Miseta, Chief Editor, Clinical Leader

Members of the International Council for Harmonization (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017.

The changes will include updating current guidance on interventional trials and expand on novel trial methodologies for drug registration. ICH members also voted to adopt an addendum to the organization's 1996 Guideline for Good Clinical Practice (E6(R1)). The addendum, referred to as ICH E6(R2), aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials.

Additionally, ICH announced that it will be creating a new guideline (ICH E19) aimed at harmonizing requirements for optimal collection of safety data during late stage pre-market and post-approval clinical investigations of new drugs and new indications for approved drugs.

DrugDev Builds Site Offerings With SecureConsent Acquisition

DrugDev has announced it will acquire SecureConsent, a platform featuring an eCconsent solution that can be deployed on tablets and other mobile devices to optimize site and patient convenience. SecureConsent has been pioneering electronic informed consent since 2003 by working closely with patients, IRBs, CROs, sponsors, hospital systems, academic institutions, and regulatory authorities to deliver the best process possible. The fully-validated solution features multimedia education, real-time reporting, and end-to-end document management. The hope is for sites to be able to create better-informed patients, eliminate paperwork, simplify remote monitoring, and ensure complete transparency for regulatory audits.

The eConsent team will continue to operate out of its headquarters near Washington DC, with SecureConsent co-founder Eric Delente assuming leadership and growth responsibilities of DrugDev’s entire portfolio of patient solutions, which also include feasibility and engagement capabilities.

 “We’re working hard to put the ‘informed’ back into ‘informed consent,’” said Delente. “Prior to starting SecureConsent, we were focused on patient education for healthcare with a proprietary learning management system. Using familiar and efficient tools, such as tablets, to deliver easily consumed informational content was a natural extension from our initial mission and passion.”

Considering 10-15 percent of audit findings are related to consent, there is significant risk for sponsors to rely on antiquated paper methods which lack control over the process, such as ensuring patients sign the right documents, use correct dates, and acknowledge protocol changes.

In recent years, support from patient advocacy groups and draft guidance from the FDA has served as catalysts for adoption of electronic informed consent. This heightened demand has necessitated rapid scalability of SecureConsent’s eConsent mobile solution. Over the past two years this has been further developed under the guidance of DrugDev Executive Chairman and active principal investigator Hugo Stephenson, MD, in the DrugDev Innovation Lab.

BMS: Adaptive Designs Are A Prospectively Planned Opportunity

At the 2016 AAPS annual meeting in Denver, Peter Trimboli, Group Leader, Drug Supply Management at Bristol-Myers Squibb (BMS), noted adaptive trial designs are a “prospectively planned opportunity.”

“Changes are made by design, not on an ad hoc basis,” said Trimboli. He added the most successful adaptive design trials are designed by nature, and that changes are made based on analysis of interim data. By looking at where they stand in the trial, companies can view interim analysis as a window for course correction. With traditional trials, it is difficult for companies to course correct.

Trimboli did note there are concerns when using adaptive designs. As a result, it is essential for sponsors to present the validity and integrity of the trial despite the modifications. “That is a key critical element that an adaptive design has to meet,” he adds.

Study Reveals Method To Ensure Phase 3 Success

A new study published by Cutting Edge Information found that 60% of surveyed life science teams agreed that risk of Phase 3 failures decreases when using adaptive design techniques in early-stage studies. Although the study found many life science companies strongly agreed with this statement, adaptive design clinical trials still face skepticism.

The data show that 20 percent of surveyed life sciences teams were indifferent to utilizing adaptive studies prior to Phase 3. And another 10 percent claimed that using these methods did not reduce Phase 3 failures.

Cutting Edge Information's study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, discusses how trial sponsors' use of adaptive studies during early development stages may yield multiple benefits that indirectly impact Phase 3 outcomes. When leveraged appropriately, simple adaptive designs that test for futility may allow companies to ditch clinical trial programs that fail to demonstrate efficacy during analyses. On the other hand, complex adaptive designs may increase companies' knowledge of successful products' efficacy.

"Certain Phase 3 outcomes are difficult to predict," said Sarah Ray senior research analyst at Cutting Edge Information. "However, others can be prevented with the right amount of time to exploratory research. Some clinical teams may shortchange their Phase 1 and Phase 2 clinical studies to move drugs from exploratory to confirmatory trials."