Safety/Efficacy Featured Articles

  1. In Genome Editing Trials, The Effects Last A Lifetime
    10/13/2017

    Sangamo Therapeutics is involved in the quickly growing field of genome editing, but with a twist. The biotech is currently recruiting patients for three rare disease clinical trials which will mark the first time a company performs genome editing in vivo. In a nutshell, the treatments will replace a patient’s defective or missing gene with a therapeutic gene that will be permanently stitched into the liver cells of the patient. 

  2. Clinical News Roundup: China To Accept Foreign Clinical Trial Data
    10/13/2017

    Clinical News Roundup for the week of October 9, 2017 with information on China accepting foreign clinical trial data, Janssen launching iSTEP technology toolset for trials, FDA’s first Patient Engagement Advisory Committee Meeting, and CTTI issuing recommendations on investigator recruitment and retention.

  3. Can We Improve On ClinicalTrials.gov?
    10/5/2017

    Today, patients and pharma professionals looking for information on clinical trials generally visit ClinicalTrials.gov. On the site, users can search by condition/disease, country, and other keywords. Patients can find studies in which to participate, and researchers are able to find information on more than 250,000 studies being conducted in the U.S. and 200 other countries. But is it time for a new database that better meets the needs of pharma executives and researchers?

  4. Become The Clinical Partner Of Choice
    9/28/2017

    Many pharmaceutical companies have started to look at their processes through the lens of valued, external partners. While companies will continue to evaluate the effectiveness of their external partners, many are increasingly looking in the mirror to see at what kind of partner they are to work with.

  5. Distrust Of Trials Declining Among Minority Populations
    9/26/2017

    Distrust of pharma companies and clinical trials has long been cited as one reason for the low enrollment numbers of minorities in clinical studies. But a new survey finds that lack of trust may be waning, while other factors continue to contribute to low participation rates.

  6. Clinical Challenges In Pet Meds Mirror Those In Human Studies
    9/21/2017

    Over the last 20 years, animals have become an integral part of the lives of their owners, and are now considered to be members of the family. That change has created a critical need in the world of medicines. Owners now expect to have the same treatments available for their four-legged family members as are available for humans. And they are willing to pay for effective treatments. This has created an opportunity for pharma companies, as there are few companies providing these medicines.

  7. How To Improve CRO Oversight With Data & Analytics
    9/19/2017

    Karen Brooks holds the title of senior director of clinical operations at Adare Pharmaceuticals, but the title may be misleading. With Adare being a growing specialty pharmaceutical company, Brooks is currently the entire clinical operations department. That means she wears many different hats, including operations, monitoring, management, recruitment, and retention. At the inaugural Clinical Leader Forum in Philadelphia, Brooks discussed her role in overseeing CROs.

  8. Is Patient Centricity Just A Buzzword?
    9/18/2017

    SCORR Marketing, along with KNect365 Life Sciences, a global community of pharma stakeholders, has produced a report on the current status of patient centricity in clinical trials. The survey collected 208 responses from industry professionals in a variety of job functions and regions. The survey tried to determine if companies are taking patient preferences into consideration and, if so, how they are doing so.

  9. To Fix Site Payments, We Need More Transparency
    9/14/2017

    One major challenge that still exists in clinical research is budget negotiations and payments to sites. Most would agree that trust and communication are vital to keeping those functions operating efficiently. The process put in place must also work for all stakeholders involved in the process.

  10. Is Your CRO Charging You The Right Price?
    9/5/2017

    If you have a trial you need to outsource to a CRO, how do you know what is the right price you should be paying for it? If you receive RFPs with a wide variation in quotes, how do you know which one is the most realistic? If the study is delayed for some reason, what extra costs will you incur? Those are questions that a panel of experts answered at the inaugural Clinical Leader Forum.