Last week FDA launched a new campaign to encourage minorities in the US to participate in clinical trials using video clips of a minority participant of clinical trials. FDA declared 2016 as “The year of Clinical Trial Diversity”; this is one of several initiatives launched this year. However, it seems these measures will have little practical effect … Read more
Last month, NIH announced the final policy for IRB review of multi-site clinical trials funded by NIH. Starting next May, all multi-site clinical trials funded by NIH must use a single IRB for all sites. This creates a new paradigm for IRB review of clinical trials aimed to reduce the redundancy and cost of IRB review. The goal … Read more
In a recent survey published in JAMA, patients overwhelmingly preferred their doctors to be dressed in white coat and tie over scrubs or business suits. Only 2% of the patients preferred their doctors to be dressed casually in T-shirts and jeans. Early on in a patient-doctor interaction, the patient forms an opinion about the knowledge and … Read more
The news of questionable science and data integrity issues at Theranos has filled prime time news for several months. Critics have variously chastised the company for all aspects of its operations. However, the blame for this does not rest only on Theranos; the industry as a whole made major mistakes in not checking one of its own. But there … Read more
FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, … Read more
Patient perspectives could be vastly different from that of the drug developers and regulators in terms of the benefits and risks of existing therapies, the medical need and relevant endpoints for clinical trials. In the recent years, FDA has aggressively courted patients to provide opinions about the regulatory review process through its Patient Focused Drug Development … Read more
Wearable devices such as smart watches, fitness devices, smart phones and mobile phone apps, and other such gadgets can be used to collect useful health-related information about the individual using them. It is often thought that using such devices one can track important clinical trial information and increase accuracy, speed and reliability of data. Recently, … Read more
FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, … Read more
The latest trend in clinical trial automation is use of BYOD, “Bring Your Own Device”, where a trial participant’s smart phone can be used to collect critical trial activities and data points such as patient diaries, symptoms, adverse events, drug supply management, and scheduling. Last year FDA released a guidance document on electronic informed consent; recently another … Read more
Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. CTTI also released … Read more
