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Question14. As a CRA you have been given the task of finding potential investigative sites for the clinical trial of a new drug that would treat AIDS. Please find and list 3 potential sites in the United States and give their profiles?

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Question14. As a CRA you have been given the task of finding potential investigative sites for the clinical trial of a new drug that would treat AIDS. Please find and list 3 potential sites in the United States and give their profiles?

Question14. As a CRA you have been given the task of finding potential investigative sites for the clinical trial of a new drug that would treat AIDS. Please find and list 3 potential sites in the United States and give their profiles?

 

Answer: As a CRA I have reviewed profiles of hundreds of clinical studies sites among which I found following three sites most potential for the study of a new AIDS drug.

 

1)The Geneva Foundation ( USA )

Tripler Army Medical Center (Recommended site of investigation)

The Geneva Foundation was created in 1993 as a non-profit organization with the sole mission to promote and support the advancement of military medicine. Their  focus is providing quality service to medical researchers and clinical trial sponsors to facilitate the successful and timely completion of research protocols nationwide. They are recognized as a leader in providing comprehensive administrative support to military medical personnel. They work with investigators in a variety of medical and surgical specialties at numerous sites located throughout the United States . These include, but are not limited to, Brooke Medical Center , Eisenhower  Medical Center , Madigan  Medical Center , San Diego  Center , Tripler Medical Center , Wilford Hall Air Force Center , William Beaumont  Center , and Walter Reed  Medical Center .

Clinical Research Experience

The Geneva Foundation has facilitated the conduct of clinical trials in military medical institutions since  1993.The Geneva Foundation regularly connects clinical trial sponsors and qualified investigators to accomplish Phase II, III, & IV research studies nationwide . Their services in  area include: Identifying research protocols appropriate for investigators and their site; Negotiating financial support and the contract on behalf of the investigator and site; Acting as a liaison between the investigator and the sponsor; Generating and submitting any documents required by the U.S. government to proceed with the protocol; Providing clinical research personnel to support all facets of the research from IRB submission and study start-up through patient recruitment and data collection to data queries and study closeout; purchasing supplies, equipment, and coordinating other necessary support; and lastly, administering funds resulting from the conduct of the research protocol.

The Geneva Foundation supports research studies in the fields of Cardiology/Vascular Diseases, Dermatology/Plastic Surgery, Endocrinology, Gastroenterology, Hematology, Immunology/Infectious Disease, Musculoskeletal, Nephrology/Urology, Neurology, Obstetrics/Gynecology, Oncology, Ophthalmology, Otolaryngology, Psychiatry/Psychology, Pulmonary/Respiratory Diseases, Rheumatology, and Trauma/Emergency Medicine. The Geneva Foundation has worked with a variety of pharmaceutical companies and Clinical Research Organizations, to include Mitek Products, Merck, Bristol-Myers Squibb, Ocularis Pharma, Kendle, King Pharmaceuticals, Pfizer, American Medical Systems, Parexel International, GlaxoSmithKline, Fujisawa Healthcare, Anthra Pharmaceuticals, ILEX, Health Decisions, Paragon, Novartis, Covance, AstraZeneca, Ortho-McNeil, Proctor & Gamble, Boehringer Ingelheim, Catalyst Pharmaceutical Research LLC, Abbott Laboratories, VIVUS, Pharmacia, KCI, ALZA Corporation, ACOSOG, ICOS Corporation, Quintiles, PPD, Aventis, Amgen, Wyeth and many more.

Investigator Experience

The Geneva Foundation has experience conducting research studies in the following therapeutic areas:

Tripler Army Medical Center

  • Cardiology
  • HIV Clinic
  • Internal Medicine
  • Pediatric Oncology
  • Cardiothoracic Surgery
  • Diabetes Management
  • General Surgery
  • General Surgery Residency
  • Hematology/Oncology
  • Infection Management
  • Ophthalmology
  • Orthopaedic Surgery
  • Pathology

Staff Expertise

Jane Taylor – Founder & Chairman of the Board, Corporate Staff; 20 years clinical trials experience

Elise Huszar – President, Corporate Staff; 10 years clinical trials experience

Troy Christensen – Executive Director, Corporate Staff; 1 year clinical trials experience

Andrea Lee – Clinical Trials Director, Corporate Staff; 11 years clinical trials experience

Patti Walker-Hickey – Clinical Trials Specialist, Corporate Staff; 6 years clinical trials experience

Karol Barstow – Clinical Research Manager, Tripler Army Medical Center 18 years clinical trials experience

Cheryl Jarman – Clinical Research Manager, Tripler Army Medical Center 15 years clinical trials experience

Sandra Gilbert – Clinical Research Coordinator, Tripler Army Medical Center 24 years clinical trials experience

Denise Harris – Clinical Research Coordinator, Tripler Army Medical Center 11 years clinical trials experience

Yeini Thompson – Clinical Research Coordinator, Tripler Army Medical Center 12 years clinical trials experience

Erinn Morris – Clinical Research Coordinator, Tripler Army Medical Center 1 year clinical trials experience

Tammy Scott – Clinical Research Coordinator, Tripler Army Medical Center6 years clinical trials experience

Julie Burr – Research Regulatory Specialist Tripler Army Medical Center 3 years clinical trials experience

Other Information

The Geneva Foundation is dedicated and built on the following  values 1) Integrity, Superior Service to Customers, and Respect to All. The Geneva Foundation remains dedicated to seeking innovative ways to improve the future of  medicine.

2) Boston University Medical Center
Clinical Research Experience

BU center has been involved in clinical research for over 50 years. They conduct research in all Study Phases.

BU Medical Center specializes in the following therapeutic areas:

  • Trauma
  • Surgery
  • Dermatology
  • Cardiovascular
  • Pulmonary
  • CNS
  • GI
  • GU
  • Renal
  • Infectious Disease/AIDS
  • Hematology-Oncology
  • Pediatrics
  • Rheumatology

They have worked with most major pharmaceutical companies as well as the following CROs:

  • Parexel
  • Covance
  • Quintiles
  • PPD
  • Pharmaco
  • and many others

Investigator Experience

They have more than 100 clinical investigators in most therapeutic areas.

 

Patient Demographics

  • Urban patient population
  • Diverse demographics and socioeconomic profile

 

Other Information

  • IRB meets 4 times/month
  • Site uses Remote Data Entry
  • Center has numerous centers of excellence in such areas as cardiovascular disease, hypertension, infectious diseases and in women’s health

Contact information:

Director, Office of Clinical Research
Boston University Medical Center
715 Albany Street
Suite A-206
Boston, MA 02118 USA
Phone: 617-414-1325
Fax: 617-414-1331

3) Arizona Research Center

 

Arizona Research Center is a free-standing, independent clinical research organization. Founded by board-certified orthopedic surgeon Joseph S. Gimbel, M.D., in 1997, the organization has grown to become one of the state’s leading research organizations.

 

Clinical Research Experience

Arizona Research Center, founded in 1997, primarily conducts phases II, III and IV studies, and has extensive and diverse research experience. Sponsors include, but are not limited to:

  • Abbott
  • Altana
  • Alteon
  • Alza
  • Anika
  • Asta Medica
  • AstraZeneca
  • Aventis
  • Bayer
  • Bertek
  • Bristol Myers Squibb
  • Celltech
  • Chiron
  • Eli Lilly
  • Emisphere
  • Endo
  • Entropin
  • Forest
  • Genzyme
  • GlaxoSmithKline
  • Insmed
  • Janssen
  • Johnson & Johnson
  • Merck
  • Napp
  • Neurocrine Biosciences
  • NeurogesX
  • Novartis
  • ONO Pharma
  • Pain Therapeutics
  • Parke Davis
  • Personal Product
  • Pfizer
  • Pharmacia/Searle
  • Proctor & Gamble
  • Progenics
  • Purdue Pharma LP
  • Roche
  • R.W. Johnson
  • Schwarz
  • TAP
  • United Therapeutics
  • Wyeth-Ayerst
  • Zycos

Multiple CRO’s have worked with Arizona Research Center . Among them are:

  • Bailer Research
  • B & B Clinical Investigators
  • Clinimetrics
  • Covance
  • INC Research
  • Ingenix/i3 Research
  • Integrium
  • Kendle
  • Omnicare
  • Paragon
  • Parexel
  • Pharmanet
  • PPD
  • PRA
  • Rheumatology Research International
  • Quintiles
  • SCIREX

Arizona Research Center has two Orthopedic Surgeons and an Internist as Principal Investigators, providing expertise over numerous therapeutic areas:

  • Cardiology / Vascular Surgery
  • Dermatology / Plastic Surgery
  • Endocrinology
  • Gastroenterology
  • Immunology / Infectious Disease / HIV
  • Musculoskeletal
  • Nephrology / Urology
  • Neurology
  • Orthopedics
  • Pain
  • Psychiatry / Psychology
  • Pulmonary / Respiratory Disease
  • Rheumatology
  • Trauma / Emergency Medicine

Staff Expertise

Regulatory Department
Arizona Research Center’s regulatory specialists process the start-up paperwork rapidly and work diligently to maintain all regulatory documents throughout the study.

Business Development
Principal Investigators and Study Coordinators are aided in study enrollment and recruitment through the work of the business development staff. These employees work diligently to pursue all avenues of patient recruitment and help the Research Center to frequently exceed enrollment standards set by study sponsors.

Clinical Research Coordinators
Arizona Research Center CRC’s work under the direction the PI in the overall, day-to-day management of clinical trials. Team leaders with extensive research experience oversee each coordinator, who can efficiently manage multiple trials.

Contact Information

Site Director
Arizona Research Center
2525 W. Greenway Rd., Suite 114
Phoenix, AZ 85023 USA
Phone: 602-863-6363
Fax: 602-863-6611
E-mail: [email protected]

 

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Question13. Why do we need harmonisation?

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Question13. Why do we need harmonisation?

Question13. Why do we need harmonisation?

 

Answer:

Harmonization in Clinical Trials –

Harmonization is Global Standards that are widely accepted, this principle today is valid for many things. What does the international harmonization (or harmonize local standards to international standards) mean?it  means that every country must share the ownership of an international standard, and every body should equally benefit from the international standards. How to make it as real? There are two key things to be noticed.

All countries must speak their requirements up to the international discussion, at the early stage of the development of the international standard in an adequate form for the discussion like it was on ICH in 60-s. The only country that has technical/marketing advantage may take a leadership of the discussion and control of the resultant standards.

Harmonisation is a very important factor in clinical trials and in Pharmaceutical industry.we needed harmonization in the interest of the patient and public to avoid unnecessary duplication without compromising  the regulatory obligation of safety, quality and efficacy

One of the objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.

The need of harmonization arises with the realization that it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions. In the United States a tragic mistake in the formulation of a children’s syrup in the 1930s was the trigger for setting up the product authorization system under the Food and Drug Administration. In Japan , government regulations requiring all medicinal products to be registered for sale started in the 1950s. In many countries in Europe the trigger was the thalidomide tragedy of the 1960s, which revealed that the new generation of synthetic drugs, which were revolutionizing medicine at the time, had the potential to harm as well as heal.

In early 1960s and 1970s we saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products. The industry, at the time, was becoming more international and seeking new global markets, but the registration of medicines remained a national responsibility. Although different regulatory systems were based on the same fundamental obligations to evaluate the quality, safety and efficacy, the detailed technical requirements had diverged over time to such an extent that industry found it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products, internationally.

The urgent need to rationalize and harmonies regulation was impelled by concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonisation (ICH) guidance provides a unified standard for the European Union, Japan , and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.  Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and that the clinical trial data are credible.

ICH has been successful in achieving harmonisation, initially of technical guidelines and more recently on the format and content of registration applications.  New approaches to the maintenance of the products of harmonisation is needed.  In addition, further harmonisation activities should be continued in a focused manner.

MAIN PRINCIPLES OF ICH GCP

1)      Clinical trials should be conducted in accordance with the ethical principles that that are consistent with GCP and the applicable regulatory requirements.

 

2)      Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

 

3)      The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

 

4)      The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

 

5)      Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

 

6)      A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

 

7)      The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

 

8)      Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

 

9)      Freely given informed consent should be obtained from every subject prior to clinical trial participation.

 

10)   All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

 

11)   The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.

12)   Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

 

13)   Systems with procedures that assure the quality of every aspect of the trial should be implemented.

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Question04. What could have happened if IRB-s were not created?

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Question04. What could have happened if IRB-s were not created?

Question12. What could have happened if IRB-s were not created? 

Answer:

“IRB” is a generic term used by FDA (and the department of Health and Human Services (HHS)) to refer to a group whose function is to review research to assure the protection of the rights and welfare of the human subjects. Food and Drug Administration (FDA) and HHS, specifically OHRP, regulations have empowered IRBs to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific,ethical, and regulatory.

IF IRB’s were not created then there will be no one to assure that the  rights and welfare of the research subjects has been protected.IRB  human subjects protection system is an essential safeguard in clinical research. I identified several significant benefits of the overall system, including its function as a safeguard against overoptimistic investigators, protecting subjects against both nonphysical and physical harms as well as  promotion of social justice .The presence of IRB system not only  keep a proper check on clinical trials but also save researches to  shut down which might happen because of some sloppy or unqualified researcher or because a subject is being harmed.

To accomplish its purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. The chief objectives of every IRB protocol review are to assess the scientific merit of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.

IRB’s make sure that the 3 areas for protectiong human research subjects has been safeguarded.These 3 areas are as follows:

1) Respect for persons

(2) Beneficence, and

(3) Justice.

A. Respect for Persons

Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.  Required by the moral principle of respect for person, informed consent contains 3 elements: information, comprehension, and voluntariness.  First, subjects must be given sufficient information on which to decide whether or not to participate, including the research procedure(s), their purposes, risks and anticipated benefits. alternative procedures, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.

Second, subjects must be able to comprehend the information that is given to them.  The presentation of information must be adapted to the subject’s capacity to understand it; testing to ensure that subjects have understood the information may be warranted.

B. Beneficence

The principle of beneficence requires both protecting individual subjects against risk of harm and consideration of not only the benefit for the individual, but also the future benefits that might be gained from the research.

In determining whether the balance of risks and benefits results in a favorable ratio, the decision should be based on thorough assessment of information with respect to all aspects of the research and systemic considerations of alternatives.  The IRB requires the investigator to provide (1) the validity of the presuppositions of the research, (2) the of the nature, probability and magnitude of risk, with as much clarity as possible, and (3) the investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

The principle of beneficence requires both protecting individual subjects against risk of harm and consideration of not only the benefit for the individual, but also the future benefits that might be gained from the research.

In determining whether the balance of risks and benefits results in a favorable ratio, the decision should be based on thorough assessment of information with respect to all aspects of the research and systemic considerations of alternatives.  The IRB requires the investigator to provide (1) the validity of the presuppositions of the research, (2) the of the nature, probability and magnitude of risk, with as much clarity as possible, and (3) the investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

Justice

Justice requires that the benefits and burdens of research be distributed fairly.  The “justness” of subject selection relates both to the subject as an individual and to the subject as a member of social, racial, sexual, or ethnic groups.

With respect to their status as individuals, subjects should not be selected either because they are favored by the researcher or because they are held in disdain (e.g., involving “undesirable” persons in risky research).  Further, “social justice” indicates an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.

Subjects should not be selected simply because they are readily available in settings where research is conducted, or because they are easy to manipulate as a result of their illness or socioeconomic condition.  Care should be taken to avoid overburdening patients that are already burdened in many ways by their infirmities and environments.  Nontherapeutic research that involves risk should use other, less burdened populations, unless the research directly relate(s) to the specific conditions of the class involved

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Question12: You are hired as a consultant by a company which is starting to manufacture a new remedy entirely based on products extracted from garlic. Would you suggest to file NDA with FDA (in USA ) or TPD (in Canada )? Support your answer with appropriate reasoning?

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Question12: You are hired as a consultant by a company which is starting to manufacture a new remedy entirely based on products extracted from garlic. Would you suggest to file NDA with FDA (in USA ) or TPD (in Canada )? Support your answer with appropriate reasoning?

Question12: You are hired as a consultant by a company which is starting to manufacture a new remedy entirely based on products extracted from garlic. Would you suggest to file NDA with FDA (in USA ) or TPD (in Canada )? Support your answer with appropriate reasoning?

Answer:

As a Consultant I would not prescribe or recommend herbal remedies without well-established efficacy because with Herbal medicines, In some cases, it is unclear which constituents produce the therapeutic effect. Testing for efficacy in this situation is obviously more complex than with synthetic drugs. Unfortunately, systematic reviews are often limited by the paucity and varied methodological quality of the primary studies, andresearch funds are generally scarce, in part because plants cannot be patented

Therefore usually complete data are NOT available from the manufacturer for the safety or effectiveness of these products.

If  the drug really works for the particular disease condition with  a minimal toxicity level and if I am sure that the answer is a definite YES then only I recommend to file NDA with FDA otherwise not.

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Question11: We will talk more about inform consent in sessions to come. Why do you think patient consent forms are so important? Please, share your opinion.

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Question11: We will talk more about inform consent in sessions to come. Why do you think patient consent forms are so important? Please, share your opinion.

Question11: We will talk more about inform consent in sessions to come. Why do you think patient consent forms are so important?  Please, share your opinion.

 

Answer:

CONSENT FORMS:

It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation, or providing personal care before a person decides whether to participate, or whether to allow a child or incapable adult to participate.

This principle reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice.

The informed consent process relies on three principles:

·         Adequate information is provided (generally, what a “reasonable person” would want to know to make a decision)

·         Participants comprehend the information and

·         Consent is given voluntarily.

The consent form includes all the following information:

  • Why the research is being done?
  • What are the goals of researchers what is going to happen during the trial and for how long.?
  • What risks and discomforts are involved in the trial?
  • What benefits can reasonably be expected from the trial?
  • What alternative treatments are available?
  • The extent to which participant records will be kept confidential.
  • The fact that participation is voluntary, and that a participant has the right to leave the trial at any time.
  • Whom to contact if questions or problems arise during the course of a study?

Patient consent forms  helps a patient to make a informed decision and ensures him that he is participating in a decision, not merely signing a form or contract, with this understanding,  the informed consent process is seen as an invitation to patient to participate in his health care decisions rather than a signed agreement. It is also very important because it proves that patient is taking part in the clinical trial voluntarily and is well informed about the trial and can leave the trial on any stage.

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Question10. Why is the completion of phase II trials alone not sufficient to gain permission to place the drug on the market? Please, share your opinion:

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Question10. Why is the completion of phase II trials alone not sufficient to gain permission to place the drug on the market? Please, share your opinion:
Question10. Why is the completion of phase II trials alone not sufficient to gain permission to place the drug on the market? Please, share your opinion:

Answer:

The completion of Phase II trial alone is not considered sufficient to gain permission because it only checks efficacy, toxicity and  dosing requirement of the investigational drug while Phase III trials are aimed at being the definitive assessment of how effective the drug is, in comparison with current ‘gold standard’ treatment and comparatively they also consist of larger patient groups and of longer duration then Phase II trials.

One of the other reasons for performing Phase III trials is that  this stage include attempts by the sponsor at “label expansion” (to show how the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug.

Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the “regulatory submission” that is provided for review to the appropriate regulatory authorities in different countries. They will review the submission, and, it is hoped, give the sponsor approval to market the drug

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Question9: In what case would you prefer to use placebo in a control group, and when do you use a standard treatment?

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Question9: In what case would you prefer to use placebo in a control group, and when do you use a standard treatment?

Question9:

 

Answer:

When there is no serious harm, it is generally considered ethical to ask patients to participate in a placebo-controlled trial, even if they may experience discomfort as a result, provided the setting is noncoercive and patients are fully informed about available therapies and the consequences of delaying treatment.

 

Clinical Trials

A placebo-controlled trial is a type of clinical trial or research study in which a placebo is used. Carefully conducted clinical trials are used by scientists to find out whether a new treatment works or not.

A placebo-controlled trial can be done in any phase, but is usually done in Phase 2 or 3.

Why Use Placebos?

People may wonder why placebos are used at all. The main reason is to account for the fact that when people improve in a clinical trial, it can be due to reasons other than the experimental treatment. People can improve in a trial because of:

·         Spontaneous recovery (they would have gotten better anyway)

·         A “clinical trial effect” (or improvement from all the extra care and attention participants receive in a trial) or

·         The “placebo effect” (something like the power of positive thinking, or the tendency for trial participants to improve when they believe they have been given an effective treatment).

In this sense, experimental drugs are like “placebo with value added.” The principle behind placebo use is to have two groups where everything is the same except for the drug. Thus, one can conclude that any difference between the two groups is due to the drug effect.

Placebos are also useful in identifying side effects. If two treatments are compared, they may have similarly high side effects. Placebos provide a “blank slate” by which to assess the adverse effects of experimental treatments. On the other hand, a PCT cannot provide the information to determine if the experimental treatment is better than the proven treatment.

When are Placebos Not Used?

There is agreement that PCTs are not conducted if there is any risk of irreversible harm to participants. For example, cancer patients would not be taken off chemotherapy or radiation therapy and people suffering from AIDS would not be asked to stop their treatment for the purpose of testing new drugs. Likewise, a depressed person who was suicidal would not be allowed to participate in a placebo-controlled trial.

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Question8: How would you recruit volunteers for phase I of a clinical trial? What strategies in recruiting of volunteers do you think would be considered as unethical or illegal? We will talk about these issues later, but we would like you to figure out first on your own, what should or should not be done in the recruiting of volunteers.

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Question8: How would you recruit volunteers for phase I of a clinical trial? What strategies in recruiting of volunteers do you think would be considered as unethical or illegal? We will talk about these issues later, but we would like you to figure out first on your own, what should or should not be done in the recruiting of volunteers.

Question8: How would you recruit volunteers for phase I of a clinical trial? What strategies in recruiting of volunteers do you think would be considered as unethical or illegal? We will talk about these issues later, but we would like you to figure out first on your own, what should or should not be done in the recruiting of volunteers.
Please, share your opinion

Clinical Trials require the use of human test subjects and can severely impact the well-being of the subjects, as well as treatments of other people and large amounts of capital for those performing the trial, therefore proper management of Clinical Trial is crucial.

Different Strategies of recruiting volunteers for Phase 1 trials are as follows:

1)      Word of mouth

2)      Advertisement in the press and local radio

3)      Increasingly internet is used to attract large number of healthy volunteers.

 

The strategies which I personally think should be considered as unethical and illegal in recruiting volunteers are:

1)      Not providing enough information to the patient about the clinical trial and about the investigational drug.

2)      Using money as a motivating factor in recruiting volunteers. We don’t have to make it so attractive that people give up doing anything else and spend all their time doing trials.

3)      Increasing people expectations about the effectiveness of a new drug.

4)      Checks are made to ensure that healthy volunteers are not taking part in trials continuously. The volunteer’s general practitioner is contacted and a volunteer’s details are entered into a database so that a trial unit can tell if the person has taken part in a trial previously.

Safeguards for volunteers and patients

Trial units are required to comply with guidelines on good clinical practice, good laboratory practice and good manufacturing practice. There are endless audits to ensure that everything is being done to maintain the subject’s safety and data integrity. Pharmaceutical companies are also required to carry indemnity policies so that patients and volunteers can be compensated for injuries incurred during a clinical trial. Volunteers need to be properly informed and educated.

 

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Question7: Please identify which one of these two clinical studies is more likely to be a clinical trial with purpose to get approval for specific product, and which one is a clinical study with no such aim?

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Question7: Please identify which one of these two clinical studies is more likely to be a clinical trial with purpose to get approval for specific product, and which one is a clinical study with no such aim?

Question7: Please identify which one of these two clinical studies is more likely to be a clinical trial with purpose to get approval for specific product, and which one is a clinical study with no such aim?

Answer:

Study A is a clinical trial  because in this we have to prove that drug X-Finil  will have a significant improvement in working memory in patients of Schizophrenia that’s why it has been tested in both normal  and  in schizophrenic patients to prove the dug efficacy in both normal and in disease condition and then investigational new drug application is sent to FDA to approve this drug, while  study B is a clinical study because in this we study that whether  intensive Physiotherapy can  improve hand function in patients with chronic stroke and, that this improvement  is related to brain reorganization or not. Study B is just a study with no aim to get approvals.

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Question5. Please, try to list the main functions of Clinical Research Associate in the interaction between FDA/TPD, Sponsor, CRO, IRB, and the Investigator. In the next sessions we will talk about these functions..

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Question5. Please, try to list the main functions of Clinical Research Associate in the interaction between FDA/TPD, Sponsor, CRO, IRB, and the Investigator. In the next sessions we will talk about these functions..

Question5. Please, try to list the main functions of Clinical Research Associate  in the interaction between FDA/TPD, Sponsor, CRO, IRB, and the Investigator. In the next sessions we will talk about these functions..

Answer:

Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.
Typical work activities include:

 

locating and briefing suitable doctors/consultants (or investigators) to conduct the trial; setting up the study centers – ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done; monitoring the trial throughout its duration which involves visiting the study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise; validating and collecting completed CRFs from hospitals and general practices; closing down study centers on completion of the trial; discussing results with the statistician. Writing technical reports on the trial is usually carried out by a medical statistician.

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Question6 Please, plan the monitoring procedures for a pre-clinical study on non-human mammals of a newly invented drug “X- medicine” acting on the reduction of allergic reactions by reducing of secretion of Histamine. State what adverse reactions could be anticipated in animals, compared with the well-known antihistamine drugs acting as selective blockers of H1 receptors. What special monitoring issues would you plan in regarding with this aspect?

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Question6 Please, plan the monitoring procedures for a pre-clinical study on non-human mammals of a newly invented drug “X- medicine” acting on the reduction of allergic reactions by reducing of secretion of Histamine. State what adverse reactions could be anticipated in animals, compared with the well-known antihistamine drugs acting as selective blockers of H1 receptors. What special monitoring issues would you plan in regarding with this aspect?

Question2. Please, plan the monitoring procedures for a pre-clinical study on non-human mammals of a newly invented drug “X- medicine” acting on the reduction of allergic reactions by reducing of secretion of Histamine. State what adverse reactions could be anticipated in animals, compared with the well-known antihistamine drugs acting as selective blockers of H1 receptors. What special monitoring issues would you plan in regarding with this aspect? 

 

Answer: Imagine that we have invented drug “X-medicine” which helps to reduce the secretion
of Histamine. We have to analyze the adverse reactions that could be
anticipated in animal experiments and we also have to compare it with the
known antihistamines drugs acting as selective blockers of H1 receptors.
We are anticipating following adverse reactions in animals:

 

1. Physical adverse reactions – dryness in one’s mouth, brash, gastritis,
rarely dysfunction of liver.
2. CNS’s adverse reactions – a headache, fatigue, drowse, an antianxiety
effect.
3. Allergic reactions – skin rash, anaphylactic shock.
I am comparing my drug to   Loratadine (Claritine). It
has the same mechanism of action and similar adverse reactions. All things
considered, I have planed following monitoring procedures.

Monitoring procedures for pre-clinical study of “X-medicine”.

1. Performing hematological, biochemical, immunological and genetic tests.
2. Electrocardiography.
3. Ophthalmic examinations.
4. Neurobehavioral tests.
5. Endoscopic test (if it possible on animals).
7. Daily physical examinations: body weight, food consumption levels,
auscultation, palpation, growth, pain and other severe adverse effects

8. Tissue analysis along with enzyme effects
9. Postmortem examination of the animal

10. Blood reactions and their evaluations will also need
to be taken care of.

 

In regarding to adverse reactions that referred about I can suggest
endoscopic test (if it possible on animals), histological examination of
pancreas, determination of concentration of neurotransmitters in blood and
cerebral spinal fluid. This analysis needs for investigating CNS’s, cardiovascular and respiratory adverse reactions.

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Question3. What is the main reason that pre-clinical study should be performed before the clinical one?

 

Pre-clinical development is a stage before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected.

The main reason that preclinical studies should be performed before clinical studies is that this information helps to start safe human testing.

The main goals of pre-clinical studies (also named preclinical studies and nonclinical studies) are to determine a drug’s pharmacodynamics (PD),pharmacokinetics (PK), ADME, and toxicity through animal testing. This data allows researchers to allometrically estimate a safe starting dose of the drug forclinical trials in humans. Pre-clinical studies must adhere to Good Laboratory Practices (GLP) in ICH Guidelines to be acceptable for submission to regulatory agencies such as the Food & Drug Administration in the United States .

Typically, both in vitro and in vivo tests will be performed. Studies of a drug’stoxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction.

The choice of species is based on which will give the best correlation to human trials. Differences in the gut, enzyme activity, circulatory system, or other considerations make certain models more appropriate based on the dosage form, site of activity, or noxious metabolites. For example, canines may not be good models for solid oral dosage forms because the characteristic carnivore intestine is underdeveloped compared to the omnivore’s, and gastric emptying rates are increased. Also, rodents can not act as models for antibiotic drugs because the resulting alteration to their intestinal flora causes significant adverse effects. Depending on a drugs functional groups, it may be metabolized in similar or different ways between species, which will effect both efficacy and toxicology.

Pre-clinical studies include a wide range of studies in a variety of systems to characterize biopharmaceutic and pharmacokinetic properties. Systems used include: in vivo animal models, isolated perfused liver, kidney, intestine, hind limb and heart, Caco-2 cell monolayer absorption model, animal and human liver microsomes. Studies include: bioavailability studies, pharmacokinetic studies, prediction of oral absorption in humans, determination of mechanisms of intestinal absorption, assessment of transport, distribution and elimination of compounds, validated models for cytochrome P450 enzymes, metabolism studies in human liver microsomes, assessment of potential for metabolic drug – drug interactions, analysis of drugs and metabolites in biological matrices, synthetic chemistry, in silico modeling.

 

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