Most Recent Articles
What if Patients and Patient Advocates Spoke About Clinical Trial Participation and the Key Issues that Affected Trial Participation?
A forum to gather Patient Advocacy Groups, their constituents, and key stakeholders in drug development to advance and insist upon meaningful change in clinical research.
In the Gut, In the Environment, On the iPad: Emerging Developments in Autism Research
We are, at last, beginning to better understand the broad range of phenotypic differences in what we classify as autism spectrum disorders.
Lessons Learned from 600+ Expert Committee Members
We asked our network of over 600 experts to share with us what they think makes an expert committee successful.
Get under the hood while the trial is running: Identify and rectify data problems before it's too late
How can sponsors maximize assay and endpoint sensitivity? And are you meeting scientific and regulatory expectations for quality data in clinical trials?
De-risking Clinical Trials Through Analytic Supported, On-Demand Medical Expertise From The World’s Leading Clinical Trial Experts
To Mitigate Placebo Response, Test, Train and Control Expectations
The placebo effect: it’s the curse of clinical trials across indications. Luckily, training patients to accurately report their symptoms has been proven to reduce placebo response.
Amendments to the NIH Guidelines: Effects on Human Gene Transfer Research
On April 25th, NIH Director Francis Collins announced the release of the amended NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The most important take-home...
4 Recurring Risks to Consider in Early Phase CNS Research
Early phase CNS research is plagued by a higher than average failure rate and complicated by a lack of discreet endpoints. So how can sponsors ameliorate their chances of success from the start?
CNS Science Has Outpaced Tool Development; It’s Time to Catch Up
For the first time in decades, we’re developing CNS drugs with new mechanisms of action. Unfortunately, our measurement tools are stuck in the past.
Site Score Card: Expert Tips for Moving Up the Ranks
How can a site move up the selection list and participate in these trials? It’s as simple as one word: metrics.
Unique Challenges for Medical Device Clinical Trials
Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
Single-Patient Expanded Access: WIRB experience in 2018
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
Is the Government Shutdown Already Impacting Drug Development?
For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
Limited IRB Review: Are You Prepared for January 21st?
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.
Infograph: Rethinking Patient Recruitment
Despite advances in science, medicine and tech, 90% of clinical trials struggle to meet enrollment. We propose flipping the funnel to address site resourcing issue and convert recruits into enrollees.
Germline Modification for HIV Prevention is Unjustified
Daniel Kavanagh, PhD, responds to recent news of germline editing of human embryos in China.
FDA Guidance: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
A brief analysis of the FDA's recent guidance on harmonizing FDA regulations with the Common Rule.
Interested in Boosting Patient Enrollment and Engagement Rates for Your Next Clinical Trial? Add a Genetic Counselor to the Mix