Formats
Finally! Evidence-based Recommendations & Tools to Maximize Effective Engagement Between Patient Groups & Sponsors
While key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, thus leading to more efficient, quality-driven clinical trials, no evidence-based guidelines for best practices have existed until now. How and when should patient groups be engaged in the research and development continuum? How do patient groups and sponsors of research best assess each other’s interests, expertise and assets to increase the chances of successful clinical trials and therapy development?
In January 2014, CTTI initiated the Patient Groups & Clinical Trials (PGCT) Project to find evidence-driven, actionable solutions to these questions. Today, we are pleased to release the culmination of these efforts at the BIO Patient and Health Advocacy Summit session titled, Best Practices for Industry and Patient Organization Collaboration in Clinical Trials. (CLICK HERE to view the slides presented at this session.) CTTI’s PGCT official recommendations identify best practices for engaging with patient groups, as well as provide case examples and tools.
CLICK HERE to download a copy of the PGCT recommendations.
To join the conversation on Twitter, follow the #PGCT hashtag and @CTTI_Trials.
New Publication: CTTI Presents a Systematic Review of Respiratory Tract Infection Trials Available on ClinicalTrials.gov
Annals of the American Thoracic Society published Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov on September 11, 2015. CTTI, in collaboration with the FDA, analyzed data from respiratory tract infection (RTI) trials registered between 2007 and 2012 on ClinicalTrials.gov to identify gaps in antibacterial research and inform possible interventions to the public health crisis of increasing antimicrobial resistance. Of the 69,779 trials registered between 2007 and 2012, 1,377 (2%) of these were RTI trials, which were found to be more likely than other infectious-disease or non-infectious-disease trials to be funded by industry. However, stratification of RTI trials by registration year revealed that industry funding is decreasing from approximately 65% of RTIs in 2007-2008 to 46% in 2011-2012. RTI trials more frequently evaluated vaccines compared to infectious-disease trials overall. Lower respiratory tract infection (LRTI) trials were mainly focused on bacterial pathogens (78.5%) and the majority of LRTI trials registered between 2007 and 2012 were treatment-focused; however, a multivariable logistic regression analysis indicated that a treatment-focused RTI trial was associated with decreased odds of publication. Despite the increasing emergence of multidrug-resistant microbes, currently FDA-approved antimicrobials were more commonly tested in RTI trials, and the number of trials investigating novel antimicrobial agents was low. Throughout the study period, the number of LRTI trials overall and prevention-oriented LTRI trials did not increase. This was partly attributed to a decrease in industry sponsorship and funding. These findings should prompt an examination of resource allocation in infectious-diseases trials and LRTI trials in particular.
“Our study is the first to characterize the spectrum of RTI trials. This is a critically important topic, as LRTIs are the most common cause of communicable-disease-related deaths worldwide and in the United States (28% and 45%, respectively) but comprise only 3% of infectious-disease trials.”
– Ruopp, et al.
Analyzed from data on ClinicalTrials.gov, Figure 2 displays the declining financial support from industry for RTI trials.
To read the publication, click here.
Recently Released: Expert Meeting Summary on IND Safety
On July 21 – 22, 2015, CTTI’s IND Safety Advancement Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:
- Present findings and conclusions from the project evidence gathering activities
- Discuss opportunities for improving the efficiency and value of the expedited IND safety reporting process
- Understand opportunities for educating stakeholders on expedited IND safety reporting best practices
Latest Edition of Clinical Trials Tackles Ethical and Regulatory Issues
A special issue on ethical and regulatory issues in pragmatic clinical trials has been published in the journal Clinical Trials. The effort was sponsored by the NIH Collaboratory, with additional support from the Patient-Centered Outcomes Research Institute (PCORI). As NIH Collaboratory pragmatic clinical trials were implemented, it became clear that ethical and regulatory complexities were some of the biggest challenges in conducting pragmatic clinical research. The NIH Collaboratory engaged groups of stakeholders, including researchers, patient advocates, bioethicists, and regulatory experts, to address a set of 11 ethical and regulatory issues. Each article in the special issue describes a particular ethical or regulatory challenge faced by pragmatic clinical trials and offers recommendations for how to protect the rights and welfare of research participants while enabling large-scale research that delivers critically needed evidence to healthcare decision-makers. The topics include alteration of informed consent, privacy, gatekeepers, vulnerable populations, and defining minimal risk research. An introduction was written by Robert M. Califf, MD, and Jeremy Sugarman, MD, MPH, who also served as editors of the issue.
New Publication: CTTI Presents Stakeholder Survey Results on Barriers and Solutions to Clinical Trial Recruitment
This week, Applied Clinical Trials published Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey. This publication is the result of the CTTI Recruitment Project Team’s efforts to gain a deeper understanding of stakeholders’ perceived barriers to recruitment across the clinical research enterprise. Several stakeholder groups, including clinical trial sponsors (industry, federal, and academic), research sites (investigators, coordinators, and executive-level staff), and patient advocacy organizations, were polled to gather information on approaches that will improve patient recruitment and enable trials to meet recruitment goals. The significant barrier most often cited by respondents was that of finding or identifying patients who meet eligibility criteria. A solution to this barrier that was proposed by a respondent was to broaden the eligibility requirements to enroll individuals more representative of the actual population. To improve recruitment efforts, respondents felt that medical record and hospital-based registry or database review were effective and often successfully employed. Additionally, building relationships and establishing referral programs with trusted clinicians were considered crucial to enhance recruitment. Overall, the majority of respondents had a positive outlook on the potential to increase recruitment rates over the next decade.
“The positive outlook on increasing clinical trial recruitment over the next 5 to 10 years among respondents is encouraging of the potential for progress to be made. It is apparent that a comprehensive recruitment strategy, rather than a single tool or solution, will be required to address the range of significant recruitment barriers identified.” – E. Mahon, et al.
To read the publication, click here.
Recently Released: Expert Meeting Summary on DMC’s
On July 28 – 29, 2015, CTTI’s Data Monitoring Committee Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:
- Present findings and conclusions from the project survey and focus groups
- Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations
The summary is now available online.