Clinical Guest Contributors

  1. An FDA Perspective On Patient Diversity In Clinical Trials

    Since the late nineteenth century, it has been well-known that individuals can vary widely in their responses to the same medication. Yet, accurately predicting and addressing the effects of that variability during drug development has continued to bedevil researchers, drug sponsors, and regulators.

  2. 4 Villains That Can Delay Your Clinical Trial Agreement (CTA) And How To Defeat Them

    Imagine for a moment you are your favorite superhero, charged with the task of saving the whole world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective — or much of a superhero, for that matter — if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of Clinical Trial Agreements (CTAs) by only addressing one or two of the “villains” contributing to this industrywide problem. 

  3. Can Mexico Become A Regional Powerhouse For Clinical Trials?

    Located between the United States and Central America, Mexico’s geography and Spanish language put it in an ideal position to act as a gateway to Latin American pharmaceutical markets. With an estimated size of $10 billion in 2016, the country’s pharmaceutical market ranked twelfth globally, lagging behind only Brazil as the second biggest market in Latin America. Mexico has a stable economy, and although it is classified as upper-middle income, it also offers lower costs than other countries.

  4. Do Patient Recruitment Advertising & Awareness Campaigns Really Work?

    Sponsors, CROs, and investigative sites are often faced with two key challenges when planning and managing clinical trials: getting patients recruited and determining how much to spend to find and enroll them. With the explosion of e-recruitment tactics (e.g., social media and digital advertising) and e-recruitment service providers over the past five years or so, there seems to be an industry-wide perception that the cost to enroll patients should be dramatically reduced compared with the use of more traditional advertising and awareness tactics.

  5. Accelerating Clinical Trial Patient Engagement & Retention Through Mobile Technology

    This article assesses the mobile health apps market, key features of successful apps, and associated timelines and costs for developing apps that engage patients across categories and conditions.

  6. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time. 

  7. The 4 Biggest Investigator Site Payment Issues — And How To Solve Them

    Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.

  8. Evidence Synthesis: Reducing The Guesswork Of Clinical Trial Design

    One of the biggest challenges to the success of new drugs is that approval and uptake rely heavily on the evidence collected during development, yet decisions on the design of clinical trials occur long before much is known about a drug or its effects. The available evidence for existing and potential competing interventions is expanding constantly, raising the stakes for efficient and appropriate study design even further.

  9. Open Source Data: Fact Or Fiction

    At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.

  10. How Many Team Members Does It Take To Determine The Study Status?

    Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?”  I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.