Guest article

2017 in review: Shaping the next-generation of clinical trials

By Leanne Madre, director of strategy, CTTI

- Last updated on GMT

(Image: Getty/DedMityay)
(Image: Getty/DedMityay)

Related tags: Clinical trials, Clinical trial

This past year, the clinical trials landscape continued to shift and adapt to promising trends—including mobile technology, real-world data, and patient engagement—that can help us build a stronger clinical trials system.

Keeping at the forefront of these approaches, the Clinical Trials Transformation Initiative (CTTI) released five sets of novel, evidence-based recommendations to help the enterprise improve the quality and efficiency of clinical trials.

CTTI works with stakeholders across clinical research to address the top barriers and biggest opportunities in clinical trials, creating resources that can be put into action by industry, academia, investigators, patient groups, and others.

Here’s a look at the latest from CTTI in 2017:

Develop novel endpoints generated by mobile technology for use in clinical trials

Integrating mobile technology into clinical trials has several potential benefits: faster and more efficient data acquisition, reduced patient burden, and studies that are more inclusive.

Despite this enormous promise, the uncertainty about how to use the data captured by mobile devices has slowed progress. CTTI recommendations and resources, including four use cases, can assist with selecting and developing viable novel endpoints that are meaningful to patients – using mobile technologies to accelerate the development and evaluation of urgently needed therapies.

Make registries into reusable platforms for conducting clinical trials

Clinical registries, if designed appropriately, can be valuable sources of real-world data, facilitating high-quality clinical trials at lower costs.

CTTI’s recommendations outline best practices for assessing and designing registries so that the data can meet expectations for FDA review of new products. This includes help determining whether registries are sufficiently relevant, robust, and reliable to be successfully used in clinical research.

Improve pediatric trials in antibacterial drug development

Pediatric trials, though critically needed, are especially difficult to complete, particularly in populations with antibacterial infections.

CTTI’s recommendations offer practical strategies to improve the quality and efficiency of pediatric antibacterial trials, such as tips for streamlining trial design to decrease burden on sites and families, approaches for improving the informed consent process, and special considerations for conducting trials with neonates.

Many of the recommendations can also be applied to improve pediatric clinical trials in other therapeutic areas.

Plan for pregnancy testing in clinical trials

Surprisingly, there are no specific guidelines around how pregnancy testing should be conducted to prevent the unintended exposure of an embryo or fetus to a study’s intervention, nor how risks should be clearly communicated to females of reproductive potential.

CTTI developed recommendations​ and an interactive web application as a standard way to plan for and make decisions about pregnancy testing in clinical trials.

These resources help assess the balance of benefits and burdens of different pregnancy testing plans and inform decisions about the appropriate strategy based on the probability of pregnant participants.

Strengthen the investigator community

A strong pool of qualified and motivated investigators is the engine for an effective clinical trials system, yet many investigators do not continue clinical research after conducting a single trial. CTTI identified reasons why investigators stop conducting trials, and designed recommendations to address investigator turnover and strengthen the investigator community.

The CTTI recommendations outline actions that different stakeholders, such as investigators, sponsors, contract research organizations, and health systems, can take to reduce investigator burden and foster a rewarding research environment.

In the year ahead, CTTI will tackle other issues related to the use of mobile technology in clinical trials, including scientific challenges and legal and regulatory barriers.

It is also actively exploring the appropriate use of real-world data sources and real-world evidence in randomized clinical trials conducted for regulatory submissions, and reexamining the GCP training status quo—investigating strategies for the effective qualification of investigators to conduct clinical trials.

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