Author: Hannah Faulkner
CTTI Article Uncovers Why Principal Investigators Conduct Multiple FDA-Regulated Drug Trials
Building on a previous study on the reasons why principal investigators conduct only one FDA-regulated drug trial (“one-and-done” investigators), a new CTTI article published in Contemporary Clinical Trials Communications explores the converse: barriers and critical factors that contribute to “active” investigators’ success while conducting multiple trials.
Through in-depth interviews with 23 experienced investigators, CTTI found that “active” investigators cited infrastructure, staff support, advance planning, and personal qualities as critical factors in successfully conducting multiple trials. They also shared many of the same barriers and frustrations that “one-and-done” investigators faced—including trial finances and patient recruitment—however, “active” investigators had developed strategies to overcome these barriers. Of particular importance, the amount and type of support to which investigators have access may represent a crucial difference between “active” and “one-and-done.”
The study resulted from CTTI’s investigator community work, which explored factors that influence investigators’ decisions to leave or remain in clinical research practice. Through this research and multi-stakeholder engagement, CTTI created a set of recommendations that systematically address barriers and implement reliable solutions to help reduce attrition of first-time and veteran investigators who leave the research environment.
New CTTI Publication Maps The Road Ahead For Decentralized Clinical Trials
A peer-reviewed article highlighting CTTI recommendations for Decentralized Clinical Trials (DCTs) was published this month in Therapeutic Innovation and Regulatory Science. The article describes the process of identifying and addressing the legal, regulatory, and practical hurdles for planning and conducting DCTs.
DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address roadblocks that could be hindering the widespread use of DCTs.
The article covers recommendations about trial design and conduct, telemedicine state licensing, medical product supply chain, mobile health care providers, investigator delegation and oversight, and safety monitoring that can help the industry navigate real and perceived barriers in the road to greater adoption.
New CTTI Publication Maps the Road Ahead for Decentralized Clinical Trials
A peer-reviewed article highlighting CTTI recommendations for Decentralized Clinical Trials (DCTs) was published this month in Therapeutic Innovation and Regulatory Science. The article describes the process of identifying and addressing the legal, regulatory, and practical hurdles for planning and conducting DCTs.
DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address roadblocks that could be hindering the widespread use of DCTs.
The article covers recommendations about trial design and conduct, telemedicine state licensing, medical product supply chain, mobile health care providers, investigator delegation and oversight, and safety monitoring that can help the industry navigate real and perceived barriers in the road to greater adoption.
Watch CTTI-hosted Webinar on FDA’s Patient Engagement Initiatives
The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online. “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:
- Andrea Furia-Helms, OC, FDA
- Michelle Tarver, CDRH, FDA
- Robyn Bent, CDER, FDA
- Diane Maloney, CBER, FDA
- Theresa Strong, Foundation for Prader-Willi Research
“Patients are at the heart of all FDA activities,” Furia-Helms said. She kicked off the webinar with an overview of the history of patient engagement at the FDA. Participants then reviewed patient engagement activities throughout the process of development and regulatory decision-making for drugs, biologics, and devices.
Bent said that patients are uniquely positioned to inform understanding of the therapeutic context for drug development and evaluation. She added that there is a need for more systematic ways of gathering patient perspectives on their conditions and treatment options.
Strong spoke from the perspective of a patient advocate working with the FDA. She said that the patient perspective, particularly with rare diseases, provides context and nuance to the associated symptoms and challenges within a disease. “We bring some experience about living with the disorder and can hopefully help FDA staff understand that laundry list of symptoms, and tease out what is important to patients and what is keeping people living with Prader-Willi syndrome from living healthy and productive lives.”
CTTI and the FDA have partnered on several patient engagement efforts, including co-creating the Patient Engagement Collaborative (PEC) and collaborating on a recent “Enhancing the Incorporation of Patient Perspectives in Clinical Trials” workshop. Additionally, CTTI has developed a robust set of recommendations and resources that help foster effective patient group engagement.
Additionally, answers to the virtual Q&A session are available here.
New Paper Offers Recommendations for Efficient Identification and Training of Investigators
CTTI has released a new preprint paper describing its recommended approach for identifying and preparing investigators and their delegates to perform clinical research. The paper suggests that by moving beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution, sponsors, CROs, investigators, and other research professionals may be able to more efficiently find and train investigators for quality research.
Specifically, CTTI recommends complementing previous GCP training with a fit-for-purpose, risk-based training approach to close identified gaps in knowledge or skills. This multifaceted approach to training can enrich understanding of how GCP principles apply to the conduct of a particular clinical trial and help investigators grasp how to better apply quality principles in a specific setting. Combining the real-world application of GCP principles with role- and protocol-specific instruction has the potential to add greater value to the investigator qualification process, leading to the higher quality conduct of trials.
CTTI used findings from qualitative research with investigators and clinical trial sponsors, along with input from an expert meeting with multiple stakeholders, to develop the recommendations. The research identified gaps and redundancies in the current training of investigators and their delegates, as well as a common theme: the didactic, one-size-fits-all approach most commonly used for training investigators and documenting their qualification often introduces redundancies and minimizes the value of previous training.
In the paper, CTTI offers detailed recommendations for how sponsors, CROs, and site teams can respond to these insights and positively shift the investigator training culture, as well as further discussion of how a targeted learning approach can better prepare investigators and their delegates to conduct quality clinical trials.