Bookworm's Pick: “A Quick Guide to Clinical Trials”

A properly designed clinical trial forms an integral part of successful drug development. However, to design and execute an effective clinical trial requires cooperation, understanding and respect of a multi-disciplinary team. The book, “A Quick Guide to Clinical Trials” explores the very essentials of clinical trials to lead the reader into the exciting arena.

Aimed at imparting a solid foundation of the clinical trials process, its drivers, checks and balances and more, this book sets out to deliver a unique view of clinical trial process, and how the reader can contribute to it? Inspired by young recruits to the pharmaceutical industry, it follows a jargon-lite style of presentation, the chapters however, are comprehensive enough for you to conceptualize a framework, which you can build upon later to include as many jargons as you please.

Further, as the book is appreciative of how challenging it can sometimes be for professionals to maintain currency of knowledge as it is generated, each chapter serves as a quick review of the clinical trials process, its drivers, checks and balances, etc. even for those who've matured in the industry.

The 14 chapters of the book have been classified in to 3 sections, namely broad overview, nuts and bolts, and the future.

1. The Broad Overview explains the significance of clinical trials, covers a short history of the FDA and clinical trials, and delves into the business aspect of pharmaceutical drug development.
2. The Nuts And Bolts section provides a comprehensive coverage of various aspects of clinical trial processes. It includes the following topics: project management, ethics in clinical research, regulatory affairs, monitoring, statistics, data management, technology in clinical trials, medical writing, the clinical research physician, and clinical trials vis-a-vis the patient.
3. The Future segment discusses the projections about the forthcoming outlook of the field, and is aptly titled “the future of clinical trials.”

The chapters of the book have been logically sequenced to move the reader gently from simple to complex. Moreover it stands out as an authoritative resource as the each of the chapters have been composed by experts and experienced clinical researchers from associated disciplines to portray the their professional roles, and to explain how they fit “into a very exciting big picture, overall.”

Carrying the catchphrase “for people who may not know it all,” the book verily addresses the growing need to understand clinical trials, as their importance has recently been highlighted by the recent events such as the “Sentinel Initiative” of the FDA, recall of drugs such as “Vioxx,” and reports of poor measurements for assessing clinical trials with children.

Key Details: Title: A Quick Guide to Clinical Trials for People Who May Not Know It All
Edited By: Drs. Madhu Davies and Faiz Kermani.
Published By: BioPlan Associates, Inc. April 2008
ISBN: 978-1-934106-08-2
Book URL: A Quick Guide to Clinical Trials

On the whole the book should serve as a single point resource to educate, appraise and refresh the reader about the world of clinical trials, in an intriguing and eloquent manner.

CenTrack's Breakthrough, InTouch Care Real Time Location System (RTLS)

Earlier this week GE Healthcare, in association with CenTrak, Inc. of Newton, PA, announced the launch of a new RFID technology capable of dividing a room or segmenting a bay by virtually creating radio frequency identification (RFID) walls. The system is capable of tracking people and equipment in complex indoor facilities as well as their outdoor periphery, automatically and accurately.

Radio-frequency identification (RFID) is an automatic method for identification that's based on storing and remotely retrieving data using devices called RFID tags or transponders.

Off late the results of a survey recently conducted showed that about 74% of those holding management positions within healthcare companies viewed RFID and Real-Time Location as emerging technologies that that would effectively enhance healthcare processes.

How it works?

Centrack's InTouch Care™ system, based on RFID technology has the capability to monitor the location of hospital staff, nurses, doctors, and patients with high accuracy (room-level or sub-room level).
In order to use the product for identification and tracking, RFID tags need to be worn by people or attached to assets viz. medical instruments. In case of InTouch system these tags are flexible and lightweight.

Further, each of the tag carries an identification number and as the tags are continuously monitored, associated with them can be known at any point of time. For instance, if a nurse took off the tag from some equipment, the information transmitted would be "Tag#702 just removed from its asset," or for a separate event it could be "Tag#3500 leaving room 1603," etc.


The interface that makes it possible to decipher these radio frequency events into human comprehensible form are softwares, or "middlewares" as they are called.

Additionally, the system entails a variety of monitors used to track the RFID Tags in hallways, large areas, rooms, and sub-room divisions.

The Technology

The uniqueness of this system is derived from Centrack's patented DualTrak technology, this technology while offering a higher accuracy and reliability doesn't involve the time consuming site analysis. Moreover, it also doesn't require continuous tuning that some other systems need.

Advantages

The main advantages of the system include, lowered total cost (also the costs associated with in-room wiring are saved), accuracy, reliability, visibility and ease of use. A system such as this can assist in and significantly enhance patient, staff workflow management, security and safety of patients and medical equipments viz. anaesthesia instrument.

In fact there seems to be quite an agreement about these, and others benefits among those occupying managerial positions in healthcare organizations. A recent survey reveals the business benefits rated as "Very Important," by managerial personnel were improving patient safety (67%), improving patient-flow management (48%), improving business processes (45%) improving productivity (48%), and technological strategic advantage (43%).

While the cost of installing an RFID based system may be somewhat more than other systems based on the bar code technology, it's on the decrease. Further, the system appears to be cost effective and could be profitable over a period of time. On the whole the system houses a great potential to facilitate many aspects of managing in hospitals and with ease.

FDA's Sentinel Initiative, A Pathway To Drug Safety

In the wake of growing instances where several well known pharmaceutical drugs have turned out to be hazardous, the federal health officials have announced the launch of the Sentinel Initiative, a long term program to increase drug safety by data mining an analysis.

Drug recalls are a costly affair for patients, governments and pharmaceutical drug manufacturers alike. The case of “Vioxx” a pain relief drug, is one such glaring example that had reportedly got the manufacturer a revenue of $2.5 billion before it was voluntarily recalled by the company. Now, the company is faced with compensating the plaintiffs with millions.

The Present System Of Drug Safety

Compared to the proposed system the present system's efficacy is limited. The present system revolves around three basic sources of information.

1. A report filed by health professionals or patients who experience serious problems and pin down their suspicion the drugs and medical devices they prescribe, dispense, or use.
2. Case reports published in the medical literature.
3. Results of post-approval and other clinical studies when they are performed.

Further, recently advances in information technology have opened up newer avenues for monitoring the performance of medical products. Consequently, the FDA has expanded the risk management processes by expanding data source identification and data query capabilities, improving risk identification, assessment and mitigation strategies.

Still the challenges are:

1. That well-conducted, randomized, controlled clinical trials cannot uncover every safety problem.
2. In a majority of cases the clinical trials aren't diverse enough, large enough and long enough in duration to extract all the information on a product's safety.
3. Clinical trials aren't able to to reliably detect rare, serious adverse reactions that occur with long latency or in subpopulations who weren't a part of the studies.
4. Another challenge is the rate at which new new medical products surface in the markets. As new products emerge the likelihood for their interactions with other foods, biologics, drugs (vaccine, surgical drug,etc) and medical instruments and devices also increases.

The Sentinel Initiative

The prime objective of the Sentinel Initiative is to create a nationwide, integrated, electronic system (or the Sentinel System) for monitoring medical product safety.

Such a system when developed and implemented in stages would enable the FDA to access the capabilities of multiple, existing data systems (e.g., medical claims databases, electronic health record systems) to further improve the Agency's current capability.

Moreover, this system entails the establishment of a public-private partnership, comprising myriad organizations (e.g., FDA, data owners, subject matter experts, other government agencies, etc.

This organization would, for instance develop short- and long-term project goals. It would comprise a system architecture, which would enable focused queries of a variety of data sources, located at remote sites.

The data sources are to be maintained by their owners, who would also provide consent before queries are performed on the system.

Access to and analysis of large amounts of data forms the key feature of this program. Such a facility would improve upon the already existing architecture and processes for Risk Identification, Risk Assessment and Risk Minimization.

Risk Identification: The present adverse event reporting program gets information about many medical products, alternative medicines etc, and from a variety of voluntary reporters (e.g., prescribers, dispensers, and patients). However, its limitations entail underreporting of suspected adverse events, incomplete information to enable assessment of causality, the Agency not being able to know the percentage of people that were affected.


Risk Assessment: These processes suffer, as most of the information is received voluntarily, and doesn't help in the evaluation of the rate, or the impact, of known adverse events, or even the comparative assessment of outcomes using various products.


Risk Minimization: This part entails minimizing the possible harm, at the same time continuing to facilitate the safe use of a product for those patients for whom it will be beneficial.

Some tools for risk minimization are:

• Targeted education and outreach tools (meant to to increase knowledge and behaviors of healthcare practitioners and consumers)
  
• Reminder systems (prompt, remind, double-check, practitioners and/or patients in prescribing, dispensing, receiving the products)
• Performance-linked access tools (systems that link product access to laboratory testing results or other documentation)

Challenges

The real challenge lies in the implementation of the project and specifically the challenges pertain to Privacy Protection and Data Security, Scientific Credibility of the analysis, Maintenance of integrity by insulation from undue influence, Systems Approach for effective, life-cycle, safety surveillance of medical products, Governance to provide for incorporation of a broad range of expertise and minimize conflict, Inclusiveness of stakeholders' inputs in the standards and processes of the system, Transparency of study results to public and Open Source availability of software code, standards and methods.

The project is in its initial stage and would be unfolded overtime in phases, to begin with the Medicare database would be utilized for analysis. If the program moves along as has been conceived and the obstacles are overcome, then it surely would prove to be a “quantum leap,” in F.D.A's capacity to monitor drug safety.

Now Pharmacists In Canada Can Write Prescriptions!

Pharmacists in New Brunswick, Canada could soon be doling out prescriptions for pharmaceutical drugs, based on the new bill that was put forward this Tuesday.

This government-sponsored bill to amend the Pharmacy Act was promised sometime back in the in the provincial health plan and was tabled on behalf of the New Brunswick Pharmaceutical Society.

According to the health ministry officials the bill has been introduced as a step in the direction of enabling the health-care providers to play a bigger part in offering patients an increased access to health care, reports cbcnews.

Though, the new bill doesn’t allow pharmacists to play doctors by diagnosing the disease, they would be allowed to write prescriptions when some of the medical conditions that have already been diagnosed by doctors. Some of the drugs for which patients could see a pharmacist include anti allergic drugs for allergies, asthma, anti-diabetic drugs for diabetes and high cholesterol.

This facility could come in handy when a patient for any reason isn’t able to see a doctor, for instance a patient who is on drugs for hypertension (high blood pressure) for 5 years and runs out of her stock of hypertensive drugs before she’s able to meet the doctor. In such a case she can visit the pharmacist and procure her prescription and supplies till she’s able to meet the doctor the next time.

For now the legislation applies to Alberta and is further being worked upon for introduction in British Columbia (B.C.), Province of Prince Edward Island (P.E.I.) and Nova Scotia, Canada. After enhancing the role of the pharmacists the, government is considering amendments to the roles of nurses and midwives as a part of the publicly funded health system.

The new convenience is being looked up to, as it can make up for the times when a General Practitioner (GP) isn’t available when you need him, and as a result many individuals have to visit walk-in clinics and emergency rooms. However, there are concerns as sometimes things could go wrong when inappropriate prescription is handed out. Consequently, the condition of the patient could worsen and they might end up in an emergency department of a hospital.

While the move does appear to be a modern one, some opine that the facility has a potential to be misused. For instance, if this convenience is extended to include CNS drugs that affect the central nervous system such as opioid pain relief drugs, it stands a greater chance for abuse.

The move seems to be an effective one in improving access to health care, at the same time, the possible pitfalls of such a measure need to be carefully considered so that patients don’t suffer.

Health Trade Show: Hospital, St Petersberg 2008

The exhibition “HOSPITAL” is the largest trade exhibition in the Northwest, Russia. The exhibition encourages the growth of co-operation and the establishment of relationships in the field of medicine between the Russia and the world.

The details of this year's exhibition are as follows:

Exhibition Name: Hospital
Date: 30 September - 2 October 2008
Venue: Russia, Saint Petersburg, Exhibition Centre Lenexpo
(V.O., Bolshoy pr., 103, metro Primorskaya)

The 2007 exhibition featured around 200 companies, and the participant countries included Russia, Belarus, Ukraine, Germany, Austria, USA, Belgium, Slovakia, Finland, Lithuania, South Korea, India and China.

This year’s event is supposed to feature conferences and discussions for clinicians, latest developments in technology, and professional contests. Leading experts from around the world would also participate.

US: Industry, Officials & Lawmakers Debate Bidding For Durable Medical Equipment

A House Ways and Means Health Subcommittee hearing attended by lawmakers, officials and representatives of the durable medical equipment industry argued a Medicare competitive bidding program for Durable Medical Equipment (DME). The program when implemented is expected to yield an average decrease of 26% in the prices of medical instruments and equipment.

The Program

The programs requires Center for Medicare and Medicaid Services (CMS) to select durable medical equipment suppliers to participate in Medicare based on bids submitted. This program comes in the wake of the 2003 Medicare law that mandated the program as part of a bigger effort to execute competitive bidding.

To begin with the program will be executed in 10 of the largest Metropolitan Statistical Areas in 2008, and will be applicable to 10 of the top durable medical equipment, prosthetics, orthotics and supplies product categories. The next year in 2009 it would be extended to 70 MSAs and more thereafter. For now the product categories are limited, though in future a larger number of categories would be covered. There are various categories of medical instruments used in hospitals some are anesthesia instruments, cardiovascular instruments, surgical instruments, etc.

The program is expected to commence from July 1, 2008 and after it’s fully implemented by 2010, it could result in savings of about $1 billion. Given, that last year in 2007 Medicare spent $8.5 billion on Durable Medical Equipment (DME), a saving of about 26% should be a welcome consequence.

The Concerns

A couple of concerns expressed during the meeting included complaints from providers being unfairly rejected, the winning suppliers not able to provide equipment in areas where they didn’t have operations, and the losing bidders suffering business failure after rejection. To this the CMS representative offered missing documentation, lack of accreditation, prices not being low enough as reasons for rejection of bids.

The other concerns raised included, that the program could limit beneficiaries' access to equipment, result in quality deterioration of services and would be punitive to high quality service providers. Further, the DME suppliers would expect reimbursement cut from Medicare if the program came to an end.

The CMS sees the program to result in cost benefits to the beneficiaries as they pay 20% of the cost of their equipment. Moreover, if the program were delayed for a year the costs could be $3.5 billion for five years and $20 billion over 10 years.

While it might not be clear whether Congress takes action on the program this year itself, that it would surely do it next year is the expectation.

Green Tea: A Dietary Supplement Against Aging

Green tea is rich in antioxidants, which prevent our bodies’ cells from damage due to oxidation. The process is not very different from preventing your car from being rusted.

Fast realizing the increasing knowledge of public about the many health benefits of antioxidants as they are being published, the marketers of cold drinks have begun promoting green tea drinks flavored with fruit juices. Apple, lemon, strawberry, peach, and pomegranate, you name it and it’s out there for sale.
Green Tea is often consumed as a dietary supplement. A dietary supplement refers to vitamins, minerals, herbal supplements and other substances (e.g weight loss supplement) meant to improve your diet. Green tea comprises EGCG or the epigallocatechin gallate that makes the tea power packed with the advantages of antioxidants.

As far as aging is concerned, many studies blame free radicals within our bodies as the ones responsible of it. Consequently, the higher the quantity of free radicals in your body, the faster you would age. Since the main job of antioxidants is to neutralize the free radicals their presence is supposed to slow down the rate of aging. Apart from green tea some common sources of antioxidants are apricots, broccoli, pumpkin, cantaloupes, spinach, sweet potatoes and tomatoes. So it makes good sense to supplement your diet with these as well.

However there’s a problem, and that is, once you drink the tea, 80 percent of its antioxidant catechins are lost during digestion, making the mechanism highly inefficient. At the same time a tasty solution to this problem exists. Studies have found that when the tea is coupled with some specific foods, antioxidant absorption becomes a lot more efficient. Out of the edibles that make it so, lemon ranks first, followed by orange, lime and grapefruit juices. In fact lemon has been found to retain 80 percent of the catechins.

No magic potion is needed, even a simple herb such as green tea can go a long way to protect your body from the harmful effects of free radicals, and tastefully too!