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.
Over a quarter of a million clinical trials are currently registered on clinicaltrials.gov. 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.
When it comes to drug development, the pharmaceutical industry has long followed the same model for how we approach clinical trials. However, we are on the precipice of a new opportunity for the entire healthcare system in which emerging technologies can help us develop and deliver medicines to patients in more agile and efficient ways than ever before.
Lupus is a complicated imbalance of the immune system with a spectrum of manifestations that vary from patient to patient and may change in the same person over time. This complexity makes treatment development challenging.
Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
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?
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