Raise your hand if you are a sponsor/CRO that wants to be the organization of choice for investigative sites. Now, raise your hand if you put your sites through endless hours of Web or e-learning training as part of the study start-up process. This is just one of several surefire ways to kill a site’s enthusiasm and commitment to working with you or on your studies. Another, for the record, is sending ill-prepared clinical research associates (CRAs) who are not training specialists to do the PowerPoint death march at site initiation visits (SIVs)!
An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.
Many of you have no doubt heard someone in your current or past organization say, “Quality, cost, and speed — pick two.” This statement refers to the perception that a project cannot achieve all three areas as priorities and therefore the organization must choose which two out of the three to prioritize.
Recently a clinical research associate (CRA) candidate I’ll call Evan approached our firm for assistance in finding a new assignment. His resume was impressive, representing strong foundations as a study coordinator with over 10 years of experience as a CRA for highly reputable CROs.
Most of us have spoken to someone and struggled to understand an accent or word choice. Even within a country, different regions can have unique language. So how do you coordinate complex projects across countries and regions, accounting for the differences in culture and honoring common objectives?
Regulation, more than just stipulating what must be done, must also define whose job it is to complete the task. The assignment of responsibility within the regulatory framework surrounding the clinical trial is essential to protecting the well-being of subjects and the validity of the trial’s data. Clear demarcation of the primary roles of sponsor and investigator and their associated responsibilities ensures that those conducting a trial are qualified and enables regulators to hold individuals and industry accountable to the high standards of ethical research.
A busy practicing physician who might be asked by a friend or a patient for a first-impression opinion of the currently pending federal Right to Try legislation will find him/herself in a position roughly analogous to the hungry child being offered candy by a stranger: viscerally tempted, but intellectually very, very wary.
Pharma companies use performance and competitive benchmarking to identify opportunities during their drug development cycle. The benchmarks are aimed at finding ways to make improvements in cost savings, lead time reduction (faster drug to market), and quality of services.
Consumer awareness of the quality of goods purchased is good practice in any industry, but in biotech and pharma, it is a regulatory requirement. One of the most common goods we purchase in this industry is a vendor’s services — their time, effort, and resources. Whether it be a lab, CRO, or data management group, the FDA mandates we, as sponsor companies, know the quality of the goods and services we purchase from them.
Healthcare is undergoing a shift in how key stakeholders approach and evaluate patient data -- driven by growing access to and general use of real-world data, such as de-identified patient data collected and analyzed from registries, electronic health records, wearable devices, and administrative and healthcare claims databases. This type of data is increasingly being utilized by industry representatives to help inform device development, health system operations, formularies and resulting coverage, and patient care decisions.
|
|
|
|
|
|
|
|
|