Are Virtual Clinical Trials the Key to Patient-Centric Drug Development?

Patient recruitment and sustained enrollment is absolutely essential to the success of drug development.  However, it’s been shown that nearly 80% of clinical trials fail to meet their enrollment deadlines.  This is thought to be due to many reasons but since the traditional model of executing clinical trials includes engaging multiple study sites and coordination of multiple patient visits to the study sites, patient enrollment is an arduous task.  In fact, travel time alone for patients to get to the doctor’s office can be a major barrier for obtaining patient data points throughout the trial. 

Merging healthcare and technology

A modern way to combat this dilemma is merging healthcare and technology.  Clinical trial sponsors are starting to implement the use of apps, monitoring devices, online social engagement platforms, etc. to recruit and retain patients in clinical trials.  In fact, Novartis just landed a deal with a LA-start-up to launch a virtual clinical trial.  Virtual clinical trials is a broad term that includes various stages of a clinical trial – recruitments, informed consent, counseling, and measuring clinical endpoints and adverse reactions – which can be conducted in the comfort of the patient’s home.

Benefits of virtual clinical trials

  1. Maximize patient recruitment and enrollment

Increase awareness throughout patient advocacy groups, etc.

  1. Sustaining patient enrollment throughout the duration of the study

Ease of reporting
No travel issues

  1. Facilitate adaptive clinical trial approaches to trial design

Real-time and exhausted clinical data

Risks of virtual clinical trials

  1. Impending regulatory issues

In the development of new drugs, serious adverse events (SAEs), including death, will occur. In these situations the FDA will need to determine how to deal with these cases and the method of reporting..

  1. Data integrity

The most important risk of a trial is how to maintain the effectiveness and integrity of data obtained during the trial. Self-reporting may augment this risk.

What You Need to Know Regarding Sharing Clinical Trial Data

With the onslaught of discussions relating to personalized medicine and patient centric approaches to drug development and our recent blog on scanning EHRs for clinical trial patient recruitment, we wanted to take a closer look at the rules and regulations involved in ownership of patient data in clinical trials.  

Traditionally, patients enrolled in clinical trials never obtain follow-up results from their lab tests, medical imaging or the results of the trial overall.  With technological advances such as eConsentmHealth, we wondered how patient clinical data ownership is considered now and how it may be considered in the future.  Additionally, what are the laws concerning this patient data according to The Health Insurance Portability and Accountability Act (HIPAA). 

 

Here’s a breakdown out what we found...

Patient data, even when decoded, cannot be shared without patient approval

This is the case in general, but of course, with every rule there is always an exception.  If an entity is interested in obtaining your information, they could potential position the data to fall under a TPO (treatment, payment or operations) exception and circumvent the need for patient approval.  The process for this goes far beyond this blog, so for more information on this, we’ll refer you to the HIPAA website page that discusses this in more detail.

Patients always have the right to collect their clinical data results

This may seem obvious, but some patients who would like access to their data do not always ask for it.  Although, realistically, the results from the data may not make sense to a lay person, it’s important that people know they do have access to all their tests and results and are always free to ask for copies.  These documents in turn, for instance, can be sent to another provider for interpretation help.

 

If an entity is making money off of patient data, the patient must be notified – no exceptions

Unfortunately, if an entity is making money off of your clinical data, you are not subject to receive payment for its use.  Yet, you must always be notified of such endeavors.  We’d like to note, we do see a sea change in this area though, with start-up companies like, LunaDNA, that will offer people a form of currency for sharing personal clinical data.

The Who, What, Why, When and How for Registering New Drugs

In the US, there are registration and listing requirements for new drugs going into clinical trials and the companies that manufacture these drugs.  Do you know if these requirements apply to your company and new investigational drug? To find you, you may look into the Code of Federal Regulations (the CFR) and in the Guidance for Industry that the FDA has made publicly available.  But these on-line resources are very exhaustive, content rich and extremely detailed. 

For a more hands-on approach, we suggest you contact the FDA’s Drug Registration and Listing System Team who are a very helpful resource to help you understand requirements specific to your unique situation and will walk you through the process if deemed necessary.

To this end, we wanted to provide you with the nuts and bolts of the requirements.

Why

  • Drug safety - Electronic listing database include comprehensive information on drug products that can include:

  1. Active pharmaceutical processing

  2. Drugs that requiring further processing

  3. Drugs manufactured exclusively for a private label distributor

  4. Drugs marketed solely as part of a kit or inner layer of a multi-level packaged product not marketed individually.

  • Companies who don’t follow the drug registration and listing process are sent FDA warning letters to resolve the issue. This is a situation you want to avoid.

Who

  • Business operations who participate in the manufacturing or processing of a human drug.

  • Business operations that have their drug enter into US commercial distribution after being manufactured or processed.

 

What

  • Active pharmaceutical ingredients or other unfinished drugs that require further processing, labeling, or packaging

  • Prescription drugs, whether or not the subject of an approved new drug application

  • Over-the-Counter (OTC) drugs, whether or not the subject of an approved application

  • Homeopathic drugs

 

When

  • Initial submission must be completed within 5 days of beginning to manufacture a drug for commercial distribution

  • All registered firms must renew their registration between Oct 1st and Dec 31st of each year by either updating previously submitted information, or certifying that no changes in registration have occurred.

 

How

  • FDA discontinued the use of paper submission in Jan 2009.

  • Businesses must register and list all products electronically using the Structured Product Labeling