Expand Safety Data for Trials of Glycemic Control in Diabetes Patients, Guidance Says
Sponsors of drugs to improve glycemic control in patients with Type 2 diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says.
Because diabetes patients might require the drug for an extended period, the guidance recommends broadening the trial’s safety database beyond results of traditional short-term studies of glycemic control drugs to include trials that represent at least:
- 4,000 patient-years of exposure to the new drug in phase 3 clinical trials;
- 1,500 patients exposed to the new drug for at least one year; and
- 500 patients exposed to the new drug for at least two years.
Comments on the draft guidance, which replaces two 2008 guidances on diabetes mellitus, are due by June 8.
Read the draft guidance here: https://bit.ly/2QezPqj.
Racial Bias and Stereotyping Still a Common Problem in Trial Recruitment
Cancer center leaders, principal investigators, referring clinicians and research staff say they do not perceive racial minorities as ideal candidates for trials, according to a new survey.
A survey sponsored by the American Cancer Society that consisted of 91 qualitative interviews at five cancer centers across the U.S. showed that the industry is withholding clinical trial opportunities from racial minority participants because of the costs associated with providing clinical care to minorities as well as negative perceptions about minorities.
The interviews were conducted by researchers from the University of Minnesota, the University of Alabama at Birmingham, Johns Hopkins University, the University of Texas MD Anderson Cancer Center and the University of California at Davis. While some clinical trial investigators do not take into account race and ethnic background when attempting to recruit for a trial, many investigators and research staff report there is a bias in recruiting racial minorities in cancer clinical trials.
To reduce bias among clinical and research professionals and improve the rate of minority enrollment in cancer clinical trials, the researchers from this survey study suggest the use of an interventional framework frequently used by medical trainees and practicing physicians that works to prevent unconscious racial attitudes and stereotypes from impacting clinical encounters.
To read the survey, click here: https://bit.ly/38Qsl3f.
Saama Technologies and Pfizer Collaborate on AI Data Management Platform
Saama Technologies and Pfizer have announced a joint venture that will utilize Saama’s Life Science Analytics Cloud (LSAC) artificial intelligence (AI) platform to aggregate, analyze, model and predict data. The goal of the collaboration is to take some of the burden off study data managers and monitors by streamlining clinical trial data management.
To train and improve the accuracy of Saama’s LSAC models, Pfizer will provide Saama with both clinical data and domain knowledge. Saama has reported that the collaboration has helped to identify efficiencies that will improve data management processes for clinical research partners.
Pivotal Acquires Online Patient-Management and Recruitment Company Akcelis
Madrid-based contract research organization Pivotal has acquired Belgium-based patient-management company Akcelis. The acquisition will allow Pivotal to harness the full-service online patient recruitment platform offered by Akcelis.
The full-service Akcelis platform includes multilingual pharma industry and recruitment experts. Pivotal’s three-year strategic business plan with Akcelis will include searching for more acquisition targets.
Fox Trial Finder Incorporates WCG CenterWatch iConnect to Optimize Patient Recruitment
The Michael J. Fox Foundation (MJFF) for Parkinson’s Research says it will incorporate the WCG CenterWatch iConnect patient recruitment platform into its web-based Fox Trial Finder to improve and streamline the process of recruiting trial participants.
Approximately 250,000 unique users access the CenterWatch iConnect tool per month. Integration of iConnect into the redesigned Fox Trial Finder will allow sponsors to better track recruitment tactic performance and return on investment across sites and vendors.