BioPharmArena.com

A patient’s willingness to participate in a clinical trial may be unaffected by the disclosure of a researcher’s financial interests in the study, unless the amount of money a researcher stands to earn depends on the results of the trial, according to a new study by researchers at the Duke Clinical Research Institute (DCRI), Wake Forest University, and the Johns Hopkins Berman Institute of Bioethics.

“We found that the patients we surveyed rated most types of financial disclosures less important in influencing their decisions to participate than other factors, like the risks and benefits of the proposed treatment,” said Kevin Weinfurt, Ph.D., deputy director of the DCRI’s Center for Clinical and Genetic Economics, and lead investigator on the study. “We also found that some patients are savvy enough to distinguish between different types of financial relationships, and they have different reactions based on these distinctions.”

The researchers published their findings in the April 2, 2008 online edition of the Journal of General Internal Medicine. The study was funded by the National Heart, Lung and Blood Institute.

More than 3,600 diabetes and asthma patients were surveyed for this study, and the researchers asked each to answer questions related to their willingness to participate in a hypothetical clinical trial. Each electronic survey contained one of five financial disclosure statements.

“The disclosure statements ranged from the generic — the doctor running the trial might benefit financially from the study — to the more specific — dealing with per capita payments, and ownership of equity on the part of the researcher or the institution,” Weinfurt said. “We found that none of the disclosures significantly affected subjects’ willingness to participate with the exception of ownership of equity on the part of the researcher.”

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MedicalNewsToday.com

Physicians appreciate patient opinions of the care that they provide, but they oppose rating Web sites that allow users to post anonymous comments about physicians because they can damage reputations and patient relationships, according to Nancy Nielsen, president-elect of the American Medical Association, USA Today reports. Nielsen said that one “disgruntled patient” can cause problems for a physician and that “doctors are not going to want to spend their time going into a (site) and correcting a smear.”

Delia Chiaramonte, a family physician and patient adviser in Maryland, said that such Web sites — which include HealthGrades, Vitals and Angie’s List — can place physicians on the defensive and damage patient relationships, both of which can reduce quality of care. However, according to their founders, the Web sites provide important information about physicians for patients. They add that the Web sites block multiple positive or negative comments about a physician by the same user (Painter, USA Today, 3/31).

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses.

Currently available in parts of Europe, this low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly). For other men, Cialis taken as needed - the previously approved dosing regimen - may be most appropriate.

In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy.

“ED can be a chronic condition like diabetes or high blood pressure,” said Ridwan Shabsigh, M.D., Director of the Division of Urology at Maimonides Medical Center in New York. “As a urologist, I know couples like to have choices and will appreciate the availability of Cialis for once daily use.”

Cialis for use as needed transformed the U.S. ED market when it was approved in 2003 as the first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Cialis for once daily use provides a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity. In consultation with their physician, patients now have the freedom to choose the dosing regimen that is appropriate for them.

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Medicalnewstoday.com

The Los Angeles Times on Monday featured a series of articles titled “Sold on Drugs” that examines the effect of drug manufacturers’ marketing techniques on physicians and consumers. Summaries appear below.

• “Under the Influence: Savvy Marketing Whets Our Appetite for Prescription Pharmaceuticals. Consumers, Doctors, Researchers — No One Is Immune“: Drug makers “do everything in their considerable power to ensure that their brand-name prescription medications are on the lips of patients and in the minds of physicians every time the two meet across an exam table,” the Times reports. The Times continues, “A growing chorus of critics says their efforts have begun to rewrite the dialogue between patient and doctor, influence physicians’ judgments and open the act of prescribing to forces more profit-minded than sacred” (Healy [1], Los Angeles Times, 8/6).
• “From Funding to Findings: When Drug Companies Conduct Research on New Pharmaceuticals, Outcomes May Be Affected — Greatly“: “[M]edical researchers, academic authorities and influential specialists are key players” in the commercial success of a drug, the Times reports. Drug manufacturers “build a corps of respected university experts who have lengthy experience with a drug prospect, financial ties to the firm that paid them to study it and, often, a direct stake in its success” when the companies form “commercial partnerships with universities, endow academic programs and teaching chairs, and pay academic medical centers to run clinical trials,” according to the Times (Healy [2], Los Angeles Times, 8/6).
• “Doctor, Just a Little Something for You: Complex Sales Strategies Go Way Beyond Freebies“: Drug companies “focus the bulk of their marketing budgets to influence” physician prescribing habits, which “profoundly affect sales of a drug company’s products,” the Times reports. The Times notes that drug makers’ marketing tactics “reach into physicians’ offices, pervade their medical specialty organizations and often shape the messages that doctors receive in educational settings” (Healy [3], Los Angeles Times, 8/6).
• “Next Step: Create the Demand; Direct, Emotional Ads for Prescription Drugs Are Everywhere. But They’re Just One Way To Get to the Consumer“: “With vast and profitable markets up for grabs, drug companies are aggressively reaching beyond doctors and taking their marketing messages directly to consumers,” the Times reports. FDA in 1997 loosened regulation of direct-to-consumer advertising, a change that “set off explosive growth in marketing aimed at a general audience long on interest and — compared with physicians — short on professional skepticism,” according to the Times (Healy [4], Los Angeles Times, 8/6).
• “In Short, Marketing Works: By Targeting Consumers and Doctors — Directly and Indirectly — Drug Makers Are Driving Sales. Why Argue With Success?“: “The pharmaceutical industry defends its promotional spending as a service to science, physicians and patients,” and the ads “also, indisputably, boost sales,” the Times reports. The Times continues, “Physicians see marketing’s effects on their patients every day,” but “ask the doctors whether the marketing influences their clinical judgments or prescribing behavior, and a chill will descend upon the room,” according to researchers who have posed such questions to physicians (Healy [5], Los Angeles Times, 8/6).
• “And Now, a Push for Change: Legislators Have Begun To Question the Drug Industry’s Pervasive Influence in Health Care. Some Doctors Are Backing Them Up“: “In recent years, politicians, consumers and physicians have begun to question sharply the effect of drug makers’ commercial appeals,” the Times reports. “Medical societies and patients groups are quietly debating the wisdom of their dependence on drug companies’ largesse,” and physicians “are rethinking, or at least disclosing, their ties to drug companies,” according to the Times. In addition, lawmakers “are drafting and passing bills aimed at blunting the effects of prescription drug marketing,” the Times reports (Healy [6], Los Angeles Times, 8/6).

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Medicalnewstoday.com

Hugh Davis

It is important that you, as an individual who is considering involvement with clinical trials, understand both the positive and negative ramifications of your involvement.

In a study done for the NIH in 1997, R. Mechanic dubbed a potential negative issue as “the zone of uncertainty.” In the way of background, patients participating in clinical research are guaranteed treatment of any side effects or complications that occur as a result of their direct participation in that trial. This is a necessary element of the consent form. “The zone of uncertainty” occasionally occurs when there is an attempt to determine whether a particular complication is a result of the trial or a natural course of that patient’s pathologic process. For example, if a patient is entered into an angina trial and suffers an exacerbation that requires his or her hospitalization (while beginning to be treated with an experimental drug as opposed to standard therapy), then who is responsible for the cost of that hospitalization: the pharmaceutical company or the patient’s insurance company? It is possible for the patient to be caught in the middle here, and he or she might have to involve an attorney to rectify this situation.

Again this is a rare occurrence.”The zone of uncertainty” issue evolved as a result of managed care. Prior to the current age, insurance companies seldom knew if their patients were involved in clinical trials. Today it is likely a patient being treated outside of the normal paradigm and referral patterns sanctioned by the HMO will be quickly discovered. Clinical trials can be good for your patients, if you keep in mind some important axioms. The first axiom for all clinical investigators must be to do no harm. It is most important that, in your medical opinion, there are no significant dangers to which you would expose your patients unnecessarily. And this, of course, includes any risk involved in stopping that patient’s cur- rent therapy.

Clearly, though, everything is relative. In a life-threatening illness, more risk might still be well within the realm of acceptability.A second axiom is that a patient should never in any way be coerced into a clinical trial. A clinical trial must be presented in a fair and balanced way and the decision to enter must be left to the patient, who needs to be free from both overt and covert influences. As that patient’s physician, you must refrain from allowing your own desires to inadvertently influence the patient. Remember that you are an authority figure, and that frequently, patients will act out of a desire to please you rather than in a way that they perceive as in their own best interests.A third important axiom is that the patient must have a complete under-standing of the risks, benefits and requirements of a clinical trial.

It is important that the consent form {which delineates safety, visit requirements, etc.) be reviewed in detail by the investigator at a level that is compatible with that patient’s language skills and intellect. It is also worth presenting this information to other members of the patient’s family, so that everyone has a clear understanding of the situation. In fact, it has always been my practice to have a patient’s family member witness his or her signature on the consent form.You and your patients may be concerned about patient safety issues.

What are the risks associated with volunteering for a clinical study? There can be risks, but the research process is designed to minimize them.Most investigators become involved in conducting phase II through phase IV trials and rarely do phase I. There will be further discussion about all the trial phases in this on-line course. However, prior to phase I where a drug is tested for the first time in healthy humans, all products undergo extensive animal testing. So, by the time a drug reaches phase II tests, much has been learned about the drug’s toxicity, half-life and potential side effects.

The general intention of each phase of trials is to further expand safety and dosing knowledge. Therefore, an investigator involving himself or herself in phase IIl trials can be assured of much more information regarding these parameters. And, phase II trials are the earliest phase of trials in which practically all clinical investigators will become involved.

As an investigator, you will receive a protocol and a drug manual. The drug manual delineates all the relevant knowledge that has been accumulated about the drug being tested. It includes animal data as well as information on phase I testing and any previous phase I and phase II - III trials done any- where in the world. A copy of this manual, along with the protocol, must be forwarded to your IRB (we will give a definition of IRB / ethic committee later in this course) prior to approval of the trial. It is vital that you, as an investigator, read this manual carefully so you can become familiar with any potential problems or side effects discovered earlier in the drug development process.

Not only does this information impinge upon your decision to take the trial, but it makes you aware of what problems to look for as the trial progresses. Please remember that you must be comfortable with the risks and benefits to your patients in the trial. If you are worried about undue hazards or side effects that seem too severe to justify, then you should not take this trial. It is impossible for an investigator to function effectively under these types of circumstances.

So, always remember that you are the final judge of what is appropriate and what is not.Most clinical trials you become involved with will not be on “first in the class” products, but on “me too” drugs. While this creates less interest for the investigator, it adds a great margin of comfort because a similar product has already been marketed, and the side effect and safety profile will probably be rather similar.It can be argued that patients in clinical trials are actually safer than patients not in clinical trials who are taking the same or similar products. This is because patients in clinical trials are much better monitored than those who are not.

Trials require many more visits to the physician than what is typical in routine practice and also, in general, much more frequent testing than would normally be done. Also, the clinical tests and parameters utilized are frequently at the highest level of technology available. Frequently, because of the thoroughness of the examinations required by clinical trials, serious and silent coexisting disorders are uncovered. During my experience conducting clinical trials, I have uncovered three malignancies only because of the extensive testing required by the protocol.

In two of the cases, the patient’s life was saved.When considering involvement in clinical trials, it is important to step back for a moment and to consider participation from a different perspective. It has been stated that the administration of one million doses of a medication is required before an adequate side effect profile is developed. In most instances, a medication is released on the market after administration of several thousand doses or less.

It is clear from the frequent withdrawal of marketed medications that many people are in danger of suffering potentially serious side effects from many medications that are assumed to be safe because they have received FDA / TPD approval. It is important to remember that every time someone takes a medication, whether it be approved, over the counter, herbal or as part of an experimental protocol, there are potential dangers.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh Davis

As a physician who conducts clinical research, you will be providing your patients with additional treatment options. This can be vitally important for people with life-threatening or chronic diseases. It also can be of major importance to those individuals who simply have not found appropriate medical solutions to more mundane illnesses.

For example, patients often cannot tolerate the current best therapy because of idiosyncratic reactions, side effects or allergies. The ability to offer all these individuals something new and potentially effective is a significant accomplishment. So, in a very real sense, a physician engaged in clinical research is providing his or her patient with the opportunity for improved medical care. Your patients will view you as a physician who is on the cutting edge of medicine.

There is another reason that becoming involved in clinical research can be good for your patients. Many people today have inadequate health insurance or none at all. For some people, the only way they can afford medical treatment for their chronic conditions and ailments is to enroll in clinical trials. Volunteers in clinical trials are not charged for either the medication or treatment, if it specifically involves the indications relevant to the trial. But it is also not unusual for patients’ other illnesses or minor complaints to be treated at no charge if they are participating in a trial. In fact, it is a good business practice to reward those patients who participate in this manner because they are actually allowing you to make more in the way of income from their participation than you would normally earn from conventionally treating them.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh Davis

Physicians are facing financial pressure: declining managed care and government reimbursement, coupled with rising malpractice insurance costs, is forcing them to increase their patient loads.

In the U.S. since 1995 the physician population has grown just 15%, according to the American Medical Association (AMA), while over the same period, the number of pharmaceutical reps has grown 94%, to more than 81,000. A recent study found that high-prescribing physicians receive three to five times as many calls from sales reps as they did 10 years ago. This competition for physicians’ time is fierce and a health strategies group study found that only 7% of pharmaceutical rep visits lasted longer than two minutes. Also, half of rep calls last less than two minutes (known as the classic “doorknob detail”), and a full 43% of visits never get past the receptionist with at least 35% of physicians are not seeing pharmaceutical reps at all.

New strategies, intended to complement traditional direct-to-physician tactics, are needed. Efficient alternative channels are now available, and their potential reach and integration with current channels will build a broader, more effective marketing platform for the future.

Physicians have many sources of medical information from which to choose, but the credibility and importance of each varies significantly. AC Nielsen/HCI’s ongoing tracking of the importance of information sources has found that in many cases, pharmaceutical companies have relied heavily on sources that are not rated highly by physicians. Expanding the breadth of communication channels to provide greater physician value and credibility is critical for the future of pharmaceutical marketing.

Potent technologies in point of care e-prescribing (or electronic prescribing) and related integrated drug reference tools are on the verge of becoming the most powerful marketing tools yet devised. These technologies allow marketers to reach physicians at the moment of truth, when physicians are making the prescribing decision.
The use of PDA- and Internet-based practice management and patient care tools has shown a dramatic jump in the last year, jumping from 11% to 16% of physicians using the Internet according to one survey.

While many promising technologies have failed to realize their potential, the momentum behind e-prescribing appears to be virtually unstoppable. The point-of-care e-prescribi ng concept and technology initially gained acceptence as a medical practice tool, and now the other key players in the health care system are recognizing the significant benefits of e-prescribing and are making adoption a priority.

The National Council for Prescription Drug Programs, Inc. (NCPDP), an accredited standards development organization, has established standards for the purpose of transmitting prescription information electronically between prescribers and dispensers. The major pharmacy benefits managers, Merck-Medco , Advance PCS , and Express Scripts , formed RxHub in 2001 to accelerate the adoption of electronic prescribing. The major pharmacists groups, The National Association of Chain Drug Stores (NACDS) and The National Community Pharmacists Associations (NCPA), formed SureScript Systems in 2001 for the same purpose. Even a major employer coalition, Leapfrog Group , is promoting the adoption of electronic prescribing to help reduce medication errors.
A few hurdles still stand in the way. Several U.S. states still do not allow prescriptions to be transmitted electronically, and federal law does not yet allow electronic controlled substance prescriptions. But this fact is likely to change in the face of lobbying, current legislative initiatives, and other pressures. The bottom line is that electronic prescribing is virtually inevitable with such a broad consensus among all the major stakeholders.

Every health care stakeholder receives benefits from e-prescribing. Patients can get more time with their physicians, greater convenience in the prescription process, and, most importantly, improved medication safety. For the pharmacies, the NACDS estimates as much as 30% of pharmacists’ time is spent verifying prescriptions. Productivity cost savings could be dramatic. The accuracy of e-prescribing also reduces prescription errors and liabilities. Payers benefit from improved formulary and treatment protocol compliance.

But it is physicians who have the most to gain from e-prescribing. New e-prescribing applications can reduce medication errors, improve patient satisfaction, and reduce practice costs.

Electronic prescribing systems can have a significant impact on practice and clinical efficiency by dramatically reducing pharmacy call backs and streamlining the prescription renewal process. According to one study, 69% of prescribers say e-prescribing has had a positive impact on improving their overall efficiency; 79% reported e-prescribing has had a beneficial impact on delivering better patient care. The study also found that 16% of physicians currently use e-prescribing, nearly a 50% jump over 2001’s level. An additional 21% of physicians expect to use e-prescribing in the next 18 months, and various estimates have projected an adoption level of greater than 50% by 2005.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Please note this article does not give any medical advice.
Kriger Research Center offers physicians an excellent clinical investigator career!
Not many people are aware of the fact that you shouldn’t be an expert in pharmaceuticals to get into this most lucrative industry!

ot many people are aware of the fact that each drug, before it makes it to the pharmacy shelf, should pass a lengthy approval and manufacturing process where many clinical trails should be done. This industry is all about regulations and rules that are easy to learn. When you know these rules and regulations, you are very attractive to any industry provider!

What do I need to become a clinical investigator?

You need to have the right background to enter this lucrative industry.

• You have to be a licensed physician.
• You need some professional orientation in international pharmaceutical regulations (ICH GCP).

Kriger Research offers a short interactive on-line program with live instructors from the industry that will prepare you for a career as a Clinical Investigator.

How do I start this career?

You won’t have much competition. Currently there is a real shortage of clinical investigators and many trials are in process. Through Kriger’s internship program, you can participate in our practical projects to get some clinical investigator experience. All internship commitments could be completed on-line.

Your experience in our ongoing projects is a unique opportunity that is critical to get a trail. We will help you to build your winning clinical research investigator resume that will attract the immediate attention of the industry.

We also will provide you with the references for your future clinical research partners. Kriger Research Center is a reputable industry player and many industry players are looking for clinical investigators with affiliation with our center.

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For more information on Clinical Research Career Training and Clinical Trials Services please contact Kriger Research Group ( http://www.kriger.com/training ) at info@kriger.com or call (866) 757-9791 (USA and Canada) or + 1(416) 630-0038 (Internationally)