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Home » Authors » Conor Hale

Articles by Conor Hale

Early Chart Reviews Can Provide Steady Flow of Potential Study Subjects, Experts Say

February 26, 2018
Conor Hale
Beginning chart reviews before initiating a site can generate a list of prequalified candidates for outreach — and give sponsors the chance to examine the study’s inclusion and exclusion criteria, and their potential to cause enrollment issues, according to experts during two WCG webinars on acceptable methods for sites and sponsors, and best recruitment practices. Read More

FDA to Require GCP Compliance for Device Trials Conducted Outside the U.S.

February 26, 2018
Conor Hale
In February 2019, the FDA will require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. Read More

SCOPE 2018: Advances in Big Data, Patient Centricity Could Shift Sponsor, CRO Relationships

February 19, 2018
Conor Hale
At the annual SCOPE conference in Orlando, Fla., clinical trials experts agreed that the traditional relationship between contract research organizations (CROs) and sponsors is evolving, alongside accelerated pursuits in big data and patient centricity — with more CROs expected to share in the risks of drug development as more of a partner than a vendor. Read More

Sensors and Wearables Transform Clinical Trials but Challenges Remain, Experts Say

February 19, 2018
Conor Hale
With a multitude of sensors, wearables and mobile devices becoming available for use in clinical trials, sponsors should conduct systematic comparisons before designing protocols, according to experts at the annual SCOPE conference, who presented the work they’ve done to demonstrate the value of using digital monitoring in their studies, as well as the obstacles they encountered. Read More

CTTI: Instituting Quality Measures Early in Trial Design Pays Off in the Long Run

February 12, 2018
Conor Hale
At a symposium marking the Clinical Trials Transformation Initiative’s 10th anniversary, industry and regulatory discussed the progress made by its Quality by Design initiative and the additional work needed to encourage the research industry to be more focused on trial quality and efficiency. Read More

FDA Clarifies Stance on Clinical Trial Reimbursements for Patient Travel, Lodging

February 5, 2018
Conor Hale
The FDA has updated its guidance to institutional review boards and clinical investigators clearly allowing reimbursements to patients in clinical trials for lodging and travel. Read More

New MIT Study Puts Clinical Research Success Rate at 14 Percent

February 5, 2018
Conor Hale
Nearly 14 percent of all drugs in clinical trials eventually win approval from the FDA — a much higher percentage than previously thought, according to a new study from the MIT Sloan School of Management. Read More

Clinical Trial Globalization Yields Emerging Markets on Every End of the Desired Spectrum

January 29, 2018
Conor Hale
With uncertainly about the impact of Brexit, and concerns about quality in India and China, drug development companies are looking to other markets to conduct clinical trials. Read More

Tufts CSDD Survey Finds Study Startup Cycles Remain Inefficient for New Sites

January 29, 2018
Conor Hale
Companies reported 28 percent longer clinical trial cycle times and startup processes for new sites compared to repeat sites, according to a study conducted by the Tufts Center for the Study for Drug Development (Tufts CSDD) and goBalto. Read More

Human CRISPR Trials Set to Get Underway, with Patents Pending

January 29, 2018
Conor Hale
International patent and U.S. courts agencies are once again setting up to possibly decide the course of clinical research, genomics and personalized drug development, this time with CRISPR. Read More
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