The 2014 ASCO Annual Meeting in Chicago provided me with the opportunity to see old friends and network with new people and companies. It is wildly overwhelming to first-time attendees like myself to experience the sheer scope of what has been put together. At least 30,000 registrants and over 4,000 exhibits in attendance, making it the largest event for biomedical researchers, pharmaceutical and biotech companies and clinical practitioners in the specialty of oncology. The following are summations of topics relevant to the Bayessoft mission and development, drawn from my exploration of exhibits, posters, presentations, and lectures at the Annual Meeting.
1. ePRO (electronic Patient-Reported Outcome)
An ePRO is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process.
The two main methods currently used for ePRO are computers/Smartphones and telephone systems.
a) Computers are most often touch-screen devices, ranging from small hand-helds such as the Palm Pilot, through tablet PCs. The smaller devices are often used as electronic diaries, designed to be used for symptom reporting on a daily basis. Larger devices are generally used in a clinic setting. Computers generally run dedicated ePRO applications - the use of the web for ePRO is not yet widespread.
b) Telephones normally use an interactive voice response system (IVR). The user calls into a dedicated phone line, and hears a spoken script which details the question, and the possible responses. Each response option is given a number, and the user presses the corresponding number key on the phone keypad to record the choice.
Utilizing iCollect365 based EMA products for the purposes of ePRO has the following benefits:
a) The FDA requires drug developers to provide data from eCRFs (electronic case report forms- filled by physicians, nurses or other health care professionals) and data from ePROs (filled by patients or their family members). A product with therapeutic properties prescribed to cancer patients is tested on its efficacy through the summarization of eCRF data containing notes on treatment recovery time. It is also important that the safety and side-effects (psychosocially and physiologically) of the drug be well investigated by analyzing ePRO data.
b) Our iCollect365 iOS Apps and Web Services were mainly developed based on the concept of Ecological Momentary Assessment, which is a perfect method for collecting and analyzing ePRO data. The iCollect365 iPhone App can be conveniently used by patients or family members to enter data on physiological, behavioral, environmental, and social parameters. Our Event-Trackers can be customized further to meet the need of ePRO.
These include the following directions:
(i) Include template questionnaires for weekly summaries of ePROs seen in different areas; see http://www.facit.org/FACITOrg/Questionnaires.
(ii) Develop Event-Trackers for events or outcomes that are expected to occur daily or frequently. We need to study this further to find example questions for different type of cancer or diseases.
(iii) Develop means to connect our iCollect365 system with current clinical trial database systems. This is also an area to study.
(iv) To have a clearer picture of competition. The coming DIA Annual Meeting, June 15 - 19 in San Diego, offers a great opportunity to know the companies in this area, their products, services, and pricing options.
2. Bayesian Adaptive Design
An adaptive clinical trial is a clinical trial that evaluates patient reactions beginning early in a clinical trial and modifies the trial in accord with those findings. Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria, and etc.. The aim is to more quickly identify drugs that have a therapeutic effect and to zero in on patient populations for whom the drug is appropriate. Therefore, adaptive clinical trial is natural solution to Personalized Medicine product development, especially for cancer treatment. In the recent years, especially within the field of oncology, Bayesian adaptive methods for clinical trials have become popular for Phase I-II clinical trials.
According to FDA guidelines, an adaptive Bayesian clinical trial can involve:
Interim looks to stop or to adjust patient accrual
Interim looks to assess stopping the trial early either for success, futility or harm
Reversing the hypothesis of non-inferiority to superiority or vice-versa
Dropping arms or doses or adjusting doses
Modification of the randomization rate to increase the probability that a patient is allocated to the most appropriate arm
Dr. Yang, founder of Bayessoft, is an expert on Bayesian adaptive design. He taught the graduate-level classes on Bayesian Inference for Personalized Medicine when he served as a faculty member at the University of California – Davis, and City University of New York. Sponsored by NIH grants, he has developed a cloud computing based parallel MCMC algorithm for the implementation of Bayesian adaptive design with high performance. We believe this line of research is also of interest and could attract many drug developers' attention. This will be further studied.
mHealth is an abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones, tablet computers and PDAs, for health services and information. The mHealth field has emerged as a sub-segment of eHealth, the use of information and communication technology for health services and information. mHealth applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care (via mobile telemedicine). A growing percentage of health-related smartphone apps are available, and some estimates predict 500 million patients will be using such apps by the year 2015. Two days ago, Apple unveiled the Healthkit app, kicking off the journey of Apple's mHealth endeavor.
Patient Registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure, and they play an important role in post marketing surveillance of pharmaceuticals and disease management. Registries are different from indexes in that they contain more extensive data. In its simplest form, a disease registry could consist of a collection of paper cards kept inside "a shoe box" by an individual physician. Most frequently registries vary in sophistication from simple spreadsheets that only can be accessed by a small group of physicians to very complex databases that are accessed online across multiple institutions.
Upon reflection on our company's physical surroundings and internal resources, we believe the merge of mHealth with Patient Registry would carry possible opportunities. First, we have UC Davis Medical Center that is only 30 minutes away from us. There, we have partners managing a Diabetes Registry with over 26,000 patients throughout the whole Sacramento area. How to collect data and making clinical decisions in real-time, with limited resource, creates a great challenge. In China, our business partner is also developing a nationwide chronic disease management network to meet the urgent needs of the aging population. With such a huge need of senior care, the clinical resources are becoming insufficient. Therefore, a telehealth solution via the combination of mHealth technologies and statistical decision is promising. Currently, we have developed the base platform of iCollect365, which can be customized for patent registry purposes. In the Bay Area, we also have iHealth Lab as a partner who would be able to back up our services with Bluetooth enabled medical devices such as the glucose meter and blood pressure monitor. This summer, Dr. Yang will visit China to investigate this opportunity further.
Bayessoft continues to participate in the latest developments in science and technology by participationg in the 3rd Annual Clinical Genome Conference. Our CEO, David Yang is attending TCGC to see for himself how the “unstoppable march of genomics into clinical practice continues.” This conference intends to assist the expansion of genomic tools to identify disease before the onset of clinical symptoms and determine individualized drug treatment leading to precision medicine. Discussions will center on topics such as:
Working with the Payer Process
Genome Variation and Clinical Utility
NGS Is Guiding Therapies
NGS Is Redefining Genomics
Interpretation and Translation to the Client
Integrating Genomic Data into the Clinic
We are eager to lend our expertise and talents to this worthy discussion.