Clinical Guest Contributors

  1. How To Effectively Use Back Translation As A QA Tool For Clinical Trial Documents

    Back translation is a powerful tool for ensuring that a clinical trial document has been accurately translated without loss of meaning; however, it is not the right QA tool for every project. The alternative is quality assessment performed by a professional translator, which will not be dealt with in this article but is important to mention as an option.

  2. Calculating A Site Effort Score (SES): It’s Not What You Think

    With all of the focus on patient centricity and patient-centered clinical trials, it’s easy for the focus on investigative sites to be lost. Prior to the patient-centricity movement, at least for a time, site engagement was the concept du jour in the industry with conferences, articles, and surveys exploring and expounding on the importance of enhancing site relationships. And while some still believe that “patient centricity starts and ends with the investigative site,”1 it seems that the needs of the sites only get cursory attention these days. Not to detract from the importance of patient centricity, but without engaged and efficiently operating sites, many of the patient-centric initiatives will fall short of expectations. As someone who obsesses about root cause analyses, I have naturally been thinking about the primary root causes for why we seem to have lost focus and interest in the sites and what we can do about it.

  3. How Will Brexit Impact The International Clinical Research Industry?

    Though the statement “we live in a global world” typically refers to healthcare and the environment, it truly applies to science, which spans country borders and languages. This is why the 2016 decision by the British electorate to leave the European Union (EU) was so significant for the international scientific community. Brexit doesn’t just apply to the U.K. and Europe; it needs to be considered for all international communities, including the clinical research industry.

  4. 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.

  5. 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. 

  6. 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.

  7. 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.

  8. 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.

  9. 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. 

  10. 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.