52 Perspectives: “ePatients. Hot or not”?

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52 Perspectives: “ePatients. Hot or not”?

This contribution to ’52 Perspectives’ comes to us from Dan Sfera, the Site Liaison for South Coast Clinical Trials. Dan is also responsible for the business development at the South Coast Clinical Trials, a specialized research company widely recognized as one of Southern California’s premier providers of clinical trials for Central Nervous System disorders and conditions such as bipolar disorder, schizophrenia, depression, Alzheimer’s Disease among many others. Dan runs a popular blog called The Clinical Trials Guru, which does a great job at discussing clinical trials in plain English.

Introduction

An industry hot topic that has began surfacing over the past few years, and seems to be picking up steam is the concept of the epatient. Websites such as patientslikeme.org, curetogether.com and iguard.org let you store your personal health info as well as collaborate with other individuals who may be taking the same medications as you or share similar symptoms, illnesses, etc. From a non-clinical trial perspective, the benefits of keeping records of your personal medical history are obvious. You can now inform your physician of your current condition and keep him updated in almost real time on your progress. An excellent blog I recently discovered that covers this topic, and is written by a guy who started keeping a history of his own medical records is http://epatientdave.com.

From a clinical trials perspective, study participants keeping track of their own medical records and being able to retrieve them when required for study participation is an Investigator’s dream come true. One of the biggest factors attributed to clinical trial study delays are slow enrollment rates by Investigative Sites. Slow enrollment rates are often due to Investigators being unable to obtain adequate medical records for the individuals who have an interest in joining the studies. If this problem is eliminated by more individuals keeping up to date records of their medical histories, enrollment rates can be rapidly enhanced. From this perspective, you can see why Big Pharma is pushing for this epatient movement to overlap itself right into the clinical trials space. However, as with all things Pharma, the real reason for their support for this movement may very well be less about patient empowerment and more about dollars and cents.

One of the natural assumptions is that this epatient can, with assistance from pharmaceutical companies and a small group of physicians, conduct their own clinical trials without having a research clinic responsible for collecting data from the patient himself. We have already started seeing this with patient diaries and other types of data collection devices that the patients themselves are solely responsible for keeping. While one can certainly see how Pharma can save a lot of money by gradually shifting more and more responsibility away from the Investigative Site and simultaneously giving more of this responsibility to the patients themselves, the truth of the matter is, study protocols are becoming increasingly more complex as the FDA is getting stricter on adverse event reporting and safety data needed before they are willing to approve a new drug. Good luck getting that epatient to give himself an EKG! However, you can bet that Pharma will do what it can to reduce costs required to conduct clinical trials, so the idea of the epatient study participant will become more and more prevalent. We have already seen Pharma begin to outsource more clinical trials in countries such as China and India, and we at TheClinicalTrialsGuru.com believe that this trend will continue. Combine Pharma’s need for reducing drug development costs along with Health Care Reform and you have the perfect storm necessary to make a push for further integrating epatients into clinical trials while eliminating some responsibilities from the Investigative Site level.

Should Investigators be alarmed?

The rise of the epatient in clinical trials should not alarm Investigator Sites, but they should be aware of this movement. For the time being, the idea of completely eliminating the Research Clinic from the clinical trials process is still a long way from actually happening. Furthermore, studies in certain therapeutic indications such as Alzheimer’s, Cancer, Diabetes and other chronic diseases or life threatening conditions can never be conducted by the epatient himself. However, in some clinical trials such as Depression, Pain, or Hypertension, the epatient can actually collect much of the data that Investigator used to collect and record. The general rule can be that the less complex the protocol is for a particular clinical trial, the more likely it will be for a group of epatients, supervised by a small group of physicians to conduct and implement the majority of the study procedures required for that particular clinical trial. In these cases, drugs can potentially be brought to market faster, cheaper, and perhaps safer. For the more complex protocols, these types of clinical trials would be impossible to conduct without the Research Center’s heavy involvement. In my humble opinion, the epatient movement into clinical trials is inevitable, but not necessarily a movement to turn this industry upside down as some may fear.

About South Coast Clinical Trials:

SCCT was founded in 2001 by Dr. Adonis Sfera, M.D. who has been serving the community in his general and geriatric pyschiatry private practice for more than 15 years, and who continues to do so at our principal trial site in Anaheim. Dr. Sfera created SCCT in hopes of aiding in the discovery of new and more effective treatments for the very challenging disorders and conditions he encountered daily in his practice. He has since assembled a team of highly experienced professionals to assist in bringing these promising treatments to the people who need them.

About Dan Sfera:

Dan Sfera, BS, MBA, is a regulatory and contract specialist, is responsible for business development and is the Anaheim Site Director. In addition, Mr. Sfera is the Site Liaison for the company and is in charge of obtaining new studies as well as handling all of the necessary study start-up activities for our multiple sites. Dan serves as the liaison between South Coast Clinical Trials and SCCT’s pharmaceutical sponsors or Contract Research Organizations, ensuring that each and every facet of the trials are in full compliance with the Food and Drug Administration and Institutional Review Boards.

To contact Dan, please Click Here

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com