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Medical Device CRO Blog

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Research Awareness and Participation Barriers

  
  
  
Research Awareness and Participation Barriers

An article was recently published in the Clinical Researcher entitled “Increasing Provider Engagement in Clinical Research Starts with Research Awareness:  Leveraging Education and Technology to Improve Participation”.  In this article, the authors indicated that whether directly or indirectly involved with clinical trials, increasing research awareness may increase health outcomes, study accrual, and patient safety.  Subsequently, the ability to enroll in a clinical research trial may improve patient care for some individuals and result in better outcomes for future patients.  Without increasing accrual, sites and sponsors are not able to efficiently conduct clinical trials.

Compassionate Use and the Animal Rule

  
  
  
Compassionate Use and the Animal Rule

In March of 2014, we wrote about Compassionate use in Unapproved Medical Devices. To briefly summarize, compassionate use refers to the use of an unapproved device or drug in a single patient or small group where the condition of the patient/group is serious and there is no alternative treatment. The FDA can use regulatory discretion to determine if an investigational drug/device can be used and FDA approval is required prior to use.  This clause has come under the spotlight recently with the treatment of two American health care workers and a Spanish priest with an experimental drug, ZMapp, developed by the pharmaceutical company MAPP Pharmaceuticals. ZMapp is a serum-based drug that previously had not been clinically tested in humans.  It represents a number of drugs and vaccines that are currently being developed  to combat Ebola, a single-stranded RNA virus that is highly pathogenic with a fatality rate of up to 90%. According to the World Health Organization, as of 16 August 2014 there have been 2240 reported cases and 1229 deaths from this disease spanning four countries in West Africa (Guinea, Liberia, Sierra Leone, and Nigeria).

Understanding the Difference Between FDA Regulations and ISO 14155

  
  
  
Understanding the Difference Between FDA Regulations and ISO 14155

As industry begins conducting more and more device trials globally, now more than ever it is crucial to understand the important differences that exist between the FDA’s regulations and the international standards of ISO 14155.  IMARC Research has created a new whitepaper that highlights these differences.

Home Health Care: The Impact on Medical Device Design

  
  
  
Home Health Care   The Impact on Medical Device Design

For a patient receiving a medical device or for the doctor who is administering the device, more often than naught, the primary concerns of either party include: “Is this device going to be effective?” and “Is this device safe?” However, what individuals may not consider when asking these types of questions is the extent to which the device designer has already taken into account such concerns. For every medical device that has its own clinical trial or has made it to post-market, there is a team of engineers and designers who make it their job to consider the structural components and environmental factors that will allow the device to remain safe, yet effective. Often times the environment that these medical devices call home is the hospital where the patient was admitted. But as home health care becomes more predominant in today’s society, designers now have a new set of challenges to consider when constructing medical device prototypes.

IMARC Research Achieves ISO 9001:2008

  
  
  
IMARC Research Achieves ISO 900 2008

Quite often – and rightfully so – the phrase it’s a matter of life and death is bandied about throughout the healthcare industry.  When the stakes are that high, doing it right – the first time,  takes on added importance.

Personalized Medicine, the FDA, and Health Care Professionals

  
  
  
Personalized Medicine, the FDA, and Health Care Professionals

Recently we have reviewed the role of direct-to-consumer genetic testing  within the sphere of personalized medicine.  Personalized medicine can refer to tailoring disease treatment, therapy, or prevention to a particular individual, often utilizing some of the genomic signatures that make each of us unique.  Today we will look at a recent FDA news release which looks at personalized medicine from the perspective of the health care professional in respect to two areas: in vitro diagnostic (IVD) companion devices and laboratory developed tests (LDT).

3 Myths Research Participants Are at Risk of Believing

  
  
  
3 Myths Research Participants Are at Risk of Believing

MYTH 1: My doctor wouldn’t have told me about the clinical trial if he/she didn’t think it was in my best interest

Keeping Track of Your Health 24/7

  
  
  
Keeping Track of Your Health 24 7

On August 5th we introduced the notion that there is an overwhelming abundance of information available at the fingertips of the consumer.  In Part One we took a closer look at the role of the FDA in Personalized Genomics and direct-to-consumer genetic tests. Now in Part Two we will take a closer look at the role of the FDA in regulating mobile medical applications.

Wading in a Sea of DNA

  
  
  
Wading in a Sea of DNA

On August 5, 2014 we introduced that the field of personalized medicine has grown rapidly and has encompassed both the field of genetic testing and mobile health apps.  Today we take a closer look at direct-to-consumer genetic tesing.  It took thirteen years for the first draft of the human genome to be completed.  In the eleven years since this monumental accomplishment the field of genomics has grown exponentially.  And the fruits of this growth are multi-faceted: tests for disease association, risk, diagnosis, treatment; the list goes on and on.  However the implications for the results of these tests are far-reaching and have a direct affect on both the individual person and on the greater collective.  In the wake of this rapid development of genomic knowledge and increasingly more powerful computers and equipment capable of processing this information, many companies have formed to provide direct to consumer, relatively low cost personalized genomic information.  And with the creation of these companies, the FDA has taken a closer look at the information being disseminated to the consumer.

We Have the Whole World in our Hands

  
  
  
We have the whole world in our hands

The amount of information an individual has at their fingertips can be staggering. This can lead to a great deal of empowerment for the consumer in medical, consumer, and social interactions.  In the medical field, improvements in technology have led to a dramatic decrease in the cost to process and analyze an individual’s DNA which has resulted in an influx of genetic tests and information available to an individual. Furthermore, the prevalence of mobile devices/apps (including mobile health apps) has grown exponentially giving consumers an awe-inducing number of choices at the buffet of instant information. As one would expect, this rapid progression has not come without growing pains.  Both the FDA and the companies creating/providing this information have had to consistently re-evaluate how and if this content falls under the auspices of Federal Regulations.

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