CTTI’s new recommendations target investigator qualification

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Olivier Le Moa)
(Image: Getty/Olivier Le Moa)

Related tags: CTTI, Clinical trial, Investigator, Fda, GCP

The new recommendations look to provide a more efficient and effective means of qualifying clinical trial investigators – to help teams ‘conduct better, more efficient clinical trials,’ says CTTI exec.

The Clinical Trials Transformation Initiative (CTTI​) recently released recommendations and resources proposing a new approach to investigator qualification – an approach that CTTI Executive Director Pamela Tenaerts said “goes beyond repetitive, identical training, and includes individual experience and protocol-specific preparation.”

Current US Food and Drug Administration (FDA) regulations require sponsors to select qualified investigators, and while good clinical practice (GCP) training is generally regarded as the industry standard for qualification, there is little evidence that this training alone is sufficient, according to CTTI.

Tenaerts explained that the new recommendations aim to provide sponsors and contract research organization (CROs) with a more efficient and effective means of qualification and help investigators and better prepare for a clinical trial.

“Ultimately, it’s about helping stakeholders streamline processes and target training to exactly what is needed, when it is needed,”​ she told us.

To develop the recommendations, CTTI brought together various experts to conduct a literature review, interviews, and a survey. The team also used other evidence-gathering methods to further explore the challenge, Tenaerts explained.

“This work led to the development of CTTI’s new recommendations and resources, which aim to help sponsors, CROs, and site teams work together to better qualify investigators and their delegates to conduct better, more efficient clinical trials,”​ she added.

Tenaerts said the new recommendations and resources help stakeholders recognize previous training and experience, and identify knowledge gaps and qualification aspects, beyond applying GCP principles.

“They also encourage collaboration, formalized mentorship, and knowledge-sharing platforms as new solutions to help ensure that site teams have the appropriate skills and knowledge they need to run high-quality clinical trials,”​ she explained.

CTTI proposes that the new recommendations be used in conjunction with its Quality by Design (QbD) recommendations​ on protocol development as well as its Investigator Community recommendations​.

The organization in July released recommendations​ on the use of mobile technology for data capture and improved clinical trials. Also in July, CTTI’s new Patient Engagement Collaborative​ selected advocates to enhance the FDA’s understanding of how to best engage with patient communities.

The Association of Clinical Research Professionals (ACRP) also is developing competence standards for principal investigators (PIs)​ as part of its goal to reduce variability in performance across various clinical research roles.

CTTI is the product of a public-private partnership between Duke University and the FDA and aims to increase the quality of clinical trials​.

Related news

Show more

Related products

RACE Act Prompts Pediatric Oncology Trials

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 01-Mar-2020 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

What do big pharma companies spend on R&D?

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

Related suppliers

Follow us


View more