Regulatory Affairs Editorial

  1. Should We Rethink Randomized Clinical Trials?

    If we want to accelerate the drug development process, is it time to reconsider randomized clinical trials? That was the main question asked at a recent colloquium that included industry leaders from pharma networks, academia, patient groups, major medical centers, and the FDA.

  2. Clinical News Roundup: FDA Sets Inaugural Meeting Of Patient Engagement Advisory Committee

    Clinical News Roundup for the week of July 23, 2017 with information on FDA’s Patient Engagement Advisory Committee, FDA guidance of IRB waivers, FDAnews joining WIRB-Copernicus Group, Right-To-Try legislation, Type 1 diabetes vaccine headed for trials, and more.

  3. Cell Therapy Trial Targets Type 1 Diabetes In Children

    Getting adult patients to take part in a clinical trial is difficult. When developing a treatment for a childhood disease, that recruitment challenge becomes even more difficult. The combination of patient age and the experimental nature of a treatment can cause concern amongst both parents and the FDA. Caladrius Biosciences is a company dealing with that challenge. The company is developing a cell therapy technology based on a patient’s own T-cells.

  4. FDA Issues Draft Guidance On Electronic Records

    The FDA has issued draft guidance for industry titled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.” The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials.

  5. Clinical News Roundup: Scientists Hate NIH Definition of Clinical Trials

    Clinical News Roundup for the week of July 16, 2017 with information on NIH’s new definition of clinical trials, Hispanics in trials, misleading registrations on, clinical trials in South Korea, and more.

  6. Could RTT Ease Access To Critical Drugs?

    The NYUSOM Working Group on Compassionate Use and Pre-Approval Access recently released a paper noting inherent problems with the proposed Right To Try (RTT) legislation proposed by Sen Ron Johnson and 46 cosponsors. The key findings were that RTT legislation would not allow patients to get drugs faster, and that FDA actually helps, rather than harms patients. Of course, not everyone agrees with the findings of the Working Group. One of those individuals is Michael S. Smith, Vice President of the Gastroparesis Patient Association for Cures and Treatments, Inc. and a patient who has lived with Chronic Intestinal Pseudo-Obstruction for nearly 30 years.

  7. Clinical News Roundup: Should Cancer Patients Find Their Own Trials?

    Clinical News Roundup for the week of May 29, 2017 with information on cancer patients finding their own trials, Marken launching a new hybrid clinical trial service, a call for clinical trial overhaul, and Califf making a new start with Verily.

  8. The Flawed Thinking Of Right To Try Legislation

    The Trickett Wendler Right To Try (RTT) Act was introduced in May 2016 by Sen Ron Johnson (R-Wis). According to Johnson, the bill would ensure terminally ill patients, their doctors, and pharmaceutical manufacturers were allowed to administer investigational treatments where no alternative treatment exists. But for all the fanfare around RTT and the slow federal drug approval process, would the RTT legislation actually help patients?

  9. Clinical News Roundup: Senate Confirms Gottlieb As FDA Commissioner

    Clinical news roundup for the week of May 14, 2017 with information on a new head of the FDA, inVentiv Health and INC Research merging, helping patients navigate cancer clinical trials, new standards for trial results, and more.

  10. Survey: 50% Of Americans Not Aware Of Clinical Trials

    Patient recruitment remains a significant challenge for pharma companies conducting clinical trials. If all potential participants were aware of clinical trials, convincing patients to participate in them would still be a challenge. But that task becomes significantly more difficult when a large percentage of the population does not even know such trials exist.