Clinical Guest Contributors

  1. 3 Good Reasons To Never Fall In Love With A Molecule

    In my 2016 book about drug development, Nesiritide,1 I used the admonishment, “Never fall in love with a molecule,” as a chapter heading. A few weeks ago, the editors of Clinical Leader asked me to expand a bit on that aphorism. That explains why I’m sitting at my desk channeling my inner Ann Landers and writing an advice column for the pharmaceutical industry. To be entirely fair, the phrase is not originally from me. In 2005, I heard it from Randall Kaye, M.D., my first boss in the industry. But it made a real impact.

  2. Clinical Events Classification: Past, Present, And Future

    Clinical events classification (CEC) — a scientifically rigorous, systematic, comprehensive, unbiased, blinded, and independent assessment of clinical outcomes, particularly for studies that span regions and clinical settings — is a critical step in clinical research. CEC is essential to secure U.S. Food and Drug Administration or European Medicines Agency approval for drugs and devices in many therapeutic areas, such as cardiovascular, nephrology, endocrinology, gastroenterology, infectious diseases, oncology, pediatrics, and respiratory medicine.

  3. CRO Partnerships 101: What Sponsors Need To Know

    Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.

  4. The Evolving Reimbursement Landscape — Considerations For Clinical Trial Design

    Sponsor companies are increasingly examining ways to integrate the payer community’s point of view into clinical development activities, a trend that could improve the chances a drug will gain market access, achieve faster adoption once launched, and better meet patient needs. With payers increasingly demanding evidence of a drug’s value before they will cover a marketed product, demonstrating both better clinical and economic benefits of a treatment takes on greater significance.

  5. Assessing The Value Of Wearables In Interventional Clinical Trials

    Advancements in biosensor technology are becoming increasingly common in the consumer space, with wrists adorned with Fitbits or similar devices, clothing embedded with “intelligent” fibers, and personal safety devices seen in healthcare facilities across the nation. Our culture is increasingly accustomed to tracking health metrics through smartphones and simple recreational wearables. In the pharmaceutical space, we are now seeing where success in the consumer segment can translate to value-adds for clinical trials.

  6. What Does Patient-Centricity Really Mean — And Why Do We Need It?

    The challenge to recruit and retain numbers of patients for Phase 3 industry-sponsored trials is not new to the industry. In fact, 48 percent of sites miss their enrollment targets and 80 percent of trials are delayed due to recruitment, but there are new opportunities to achieve recruitment goals while also minimizing dropout. 

  7. Do New Standards Make It Easier To Involve Patients In Research?

    With over 7,000 medicines currently being developed, the future of medicine looks exciting, but there are still questions: How do we achieve this future, and do we really need more standards or regulations … or more freedom?

  8. Digital R&D: 4 Ways To Maximize Patient Engagement In Clinical Trials

    The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials. This is the first of two articles that shares interview findings and insights published in the new Deloitte Center for Health Solutions report Digital R&D: Transforming the future of clinical development.

  9. India Making Way For Separate Clinical Trials Rules

    The key law that governs the pharmaceutical industry in India is the Drugs and Cosmetics (D&C) Act, 1940 and Rules, 1945. Over time, several amendments have been made to the D&C Act and rules. Schedule Y and Part XA (which covers rules 122A, 122B, 122D, 122DA, 122DAB, 122DAC, 122DB, 122DC, 122DD, and 122E) describe the various procedures for importing or manufacturing new drugs for sale or undertaking clinical trials (CTs) in the country. The Central Drugs Standard Control Organization (CDSCO), the national regulatory agency (also known as the Central Licensing Authority), regulates CTs in India.

  10. Health Citizenship: A New Social Contract To Improve The Clinical Trial Process

    Over a quarter of a million clinical trials are currently registered on It’s no wonder that society has high hopes for the next cure for cancer, a breakthrough in Alzheimer’s disease treatment, and more effective prevention of common conditions such as strokes.