Written By: Liz Rogers
We sat down with Parallel 6 advisory board member Craig Hill, Ph.D., to discuss the industrial medical diagnostics field and how it can tie in with Clinical 6™. Dr. Hill has nearly 30 years of experience working in research, product development and scientific/clinical affairs. He spent 20 years at Gen-Probe Inc. working in molecular infectious disease diagnostics with external scientific collaborations on clinical trials and scientific publication/presentation programs. It is clear that the experience and insight that Dr. Hill provides as an advisory board member at Parallel 6 has been an incredible asset.
- As a member of the Parallel 6 Advisory Board, how can Clinical 6™ impact clinical patient management of infectious diseases, i.e. HIV, TB?
Clinical 6™ could be very useful for managing patients who are taking long-term medications for infectious diseases such as HIV, HCV and TB. Mobile technology is particularly important for directly observed therapy (DOT) for TB patients as well as many non-adherent HIV infected patients. DOT is currently used worldwide with most newly diagnosed active TB patients to assure that patients take several daily medications over the six-month period necessary to cure the disease. This traditionally has involved having a health worker visit the patient’s home on a daily basis to watch them take the appropriate medication. DOT is essential for TB treatment since many patients are poorly adherent with finishing the drug regimen resulting in relapse of the disease and potentially creating drug-resistant strains of TB. The DOT process is labor and cost intensive, requires transportation, restricts patient mobility and may be difficult to implement when patients are far from healthcare centers. Mobile technology can make this process much more efficient and economical by having the patient create and send a cell phone video of themselves taking the medicine to the healthcare worker. This video DOT method has been shown to be very successful and is being implemented in many areas worldwide.
- How can mobile technology advance R&D efforts in the in vitro diagnostic (IVD) industry?
Mobile technology can be used in the IVD industry for conducting patient clinical trials to create medical evidence to characterize new IVDs during development and to gain regulatory approval. This technology is particularly important for use in large prospective clinical trials of new diagnostic assays that may require many thousands of patients. The technology is particularly useful for longitudinal studies when patients may require testing on a regular basis with both the new IVD and comparator diagnostic tests and procedures.
- Please describe the process for creating medical evidence for diagnostic products and how it may differ from patient-centric clinical trials.
There are two main routes that may be used to create medical evidence for FDA approval of IVD products: the 510k clearance and the pre-market approval (PMA) processes. A 510k clearance is used for diagnostic products that are substantially equivalent to those already on the market and involve relatively low-risk diseases. These types of studies are relatively simple and can often use stored samples from previous studies together with patient data associated with the samples. A 510k study is usually much simpler, rapid and economical compared to a patient-centric drug trial.
In contrast, a study for PMA approval is typically much more complex and will usually require a prospective study with the enrollment and monitoring of patients similar to that done in a clinical trial for drug approval. PMA approvals are usually required for IVDs that are unique and/or associated with high-risk diseases such as HIV and cancer. PMA studies will often require multiple samples from patients over a period of time, comparison with existing diagnostic modalities, treatment if needed, and follow-up of the patients to observe medical outcomes. Mobile technology can benefit from PMA clinical trials by greatly improving patient recruitment, communication, and coordination of the patients, laboratories, physicians and CROs required to conduct these studies.
- Does the diagnostic industry have a role in precision medicine?
Diagnostic products have a central role to play in precision medicine through the need for companion diagnostics (CDs). CDs are fundamental to providing the information needed for the safe and effective use of a therapeutic. A CD may be used to identify patients most likely to respond to a particular therapeutic as well as those who may be at higher risk for serious side effects.
- What advancements in biotech do you anticipate in the near future?
The increasing complexity of diagnostic assays and in particular companion diagnostics will require the use of higher throughput methods such as microfluidics in tandem with “lab on a chip” methods that can miniaturize IVDs using chips similar to computer microchips. This technology can by used for high-throughput parallel testing of multiple diagnostic markers in a much shorter period of time than traditional diagnostics. These methodologies are also leading to improved point-of-care tests that could be used in remote areas where clinical labs are not readily available. These technologies will open the way to more precise, economical and rapid methods for determining the most optimal treatments for patients with serious diseases.