American Academy of Pharmaceutical Physicians Comments on Clinical Trial Process

Apr 19, 2001, 01:00 ET from American Academy of Pharmaceutical Physicians

    RALEIGH, N.C., April 19 /PRNewswire/ -- There has been considerable recent
 public attention to the issues surrounding patient participation in the
 clinical trial process involved in drug discovery and development. "The recent
 news program 60 Minutes aired by CBS on Sunday April 1 added very little to
 this discussion," commented Academy President, Henry Richards, MD.  "The
 program re-examined isolated examples of criminal misconducts prosecuted
 nearly 4 years ago. Those knowledgeable about the clinical trial process
 realize that there are numerous checks and balances in the system, which are
 specifically intended to protect the rights and interests of patients
 participating in these studies. Misconduct occurs in a small number of cases
 not only across the spectrum of medical practice and research, but across the
 entire spectrum of human behavior. For a profession such as pharmaceutical
 medicine, the real question is what steps are taken to prevent unethical
 behavior, what measures are taken to identify misconduct as early as possible,
 and what can be done to minimize the harm to the individual and to society.
 Sadly, these important issues were not at all addressed in the 60 Minutes
 program."
     "The AAPP commends the many thousands of patients who willingly volunteer
 for clinical trials each year," Dr. Richards continued. "They do this in the
 hopes of helping others and in discovering new treatments for diseases.
 Surveys have shown that most research participants feel that volunteering for
 trials is worthwhile, that they would participate again, and that they would
 recommend participation to family members."
     Dr. Richards noted that "patients should realize that there is never a
 requirement for them to enter clinical trials. They should only do so as
 willing volunteers and they should fully understand that they will not suffer
 any consequences if they do not wish to enter a trial, or wish to drop out at
 any stage. The physician in charge of the investigation should be able to
 answer any questions about the study at any time that they have them."
     The American Academy of Pharmaceutical Physicians has recently recommended
 the creation of a patient handbook regarding clinical investigation, which
 will outline the process, responsibilities, risks and benefits of
 participation in clinical trials. Topics will include information regarding
 the system of checks and balances inherent in human research including these
 facts:
 
           Clinical trials are only conducted by licensed, registered
           physicians. Each physician is bound both by ethical professional
           standards and appropriate state licensing laws.
 
           Human Subject Review Boards or Institutional Review Boards
           (also known as 'ethics committees') review each protocol and patient
           consent form before any trial is allowed to start for each study
           site.  The study physician is required to comply with this Board's
           requirements and to promptly notify if side effects occur or when
           other new information regarding a drug under investigation becomes
           available.
 
           The U.S. Food and Drug Administration (FDA) is responsible for
           oversight for all pharmaceutical studies involving drugs that it has
           not yet approved for use. The FDA not only reviews the protocols and
           side effects for each drug, but also has responsibility and the
           authority to inspect the Human Subject Review Boards and the
           clinical investigator for compliance with regulations.
 
           Additional governmental oversight, supervised by the Office of the
           Inspector General has also recently been added for the clinical
           study process.
 
     Dr. Richards concluded, "The American Academy of Pharmaceutical Physicians
 is committed to the safety of patients first and foremost and advocates
 improvements in the entire process of drug discovery and development and
 supports appropriate efforts which improve the clinical trial process. In this
 regard we have confidence that the current system of clinical investigations
 generally works very well and the disclosure of occasional inappropriate
 activity is evidence that the vigilance inherent in the system is operating as
 intended."
 
 

SOURCE American Academy of Pharmaceutical Physicians
    RALEIGH, N.C., April 19 /PRNewswire/ -- There has been considerable recent
 public attention to the issues surrounding patient participation in the
 clinical trial process involved in drug discovery and development. "The recent
 news program 60 Minutes aired by CBS on Sunday April 1 added very little to
 this discussion," commented Academy President, Henry Richards, MD.  "The
 program re-examined isolated examples of criminal misconducts prosecuted
 nearly 4 years ago. Those knowledgeable about the clinical trial process
 realize that there are numerous checks and balances in the system, which are
 specifically intended to protect the rights and interests of patients
 participating in these studies. Misconduct occurs in a small number of cases
 not only across the spectrum of medical practice and research, but across the
 entire spectrum of human behavior. For a profession such as pharmaceutical
 medicine, the real question is what steps are taken to prevent unethical
 behavior, what measures are taken to identify misconduct as early as possible,
 and what can be done to minimize the harm to the individual and to society.
 Sadly, these important issues were not at all addressed in the 60 Minutes
 program."
     "The AAPP commends the many thousands of patients who willingly volunteer
 for clinical trials each year," Dr. Richards continued. "They do this in the
 hopes of helping others and in discovering new treatments for diseases.
 Surveys have shown that most research participants feel that volunteering for
 trials is worthwhile, that they would participate again, and that they would
 recommend participation to family members."
     Dr. Richards noted that "patients should realize that there is never a
 requirement for them to enter clinical trials. They should only do so as
 willing volunteers and they should fully understand that they will not suffer
 any consequences if they do not wish to enter a trial, or wish to drop out at
 any stage. The physician in charge of the investigation should be able to
 answer any questions about the study at any time that they have them."
     The American Academy of Pharmaceutical Physicians has recently recommended
 the creation of a patient handbook regarding clinical investigation, which
 will outline the process, responsibilities, risks and benefits of
 participation in clinical trials. Topics will include information regarding
 the system of checks and balances inherent in human research including these
 facts:
 
           Clinical trials are only conducted by licensed, registered
           physicians. Each physician is bound both by ethical professional
           standards and appropriate state licensing laws.
 
           Human Subject Review Boards or Institutional Review Boards
           (also known as 'ethics committees') review each protocol and patient
           consent form before any trial is allowed to start for each study
           site.  The study physician is required to comply with this Board's
           requirements and to promptly notify if side effects occur or when
           other new information regarding a drug under investigation becomes
           available.
 
           The U.S. Food and Drug Administration (FDA) is responsible for
           oversight for all pharmaceutical studies involving drugs that it has
           not yet approved for use. The FDA not only reviews the protocols and
           side effects for each drug, but also has responsibility and the
           authority to inspect the Human Subject Review Boards and the
           clinical investigator for compliance with regulations.
 
           Additional governmental oversight, supervised by the Office of the
           Inspector General has also recently been added for the clinical
           study process.
 
     Dr. Richards concluded, "The American Academy of Pharmaceutical Physicians
 is committed to the safety of patients first and foremost and advocates
 improvements in the entire process of drug discovery and development and
 supports appropriate efforts which improve the clinical trial process. In this
 regard we have confidence that the current system of clinical investigations
 generally works very well and the disclosure of occasional inappropriate
 activity is evidence that the vigilance inherent in the system is operating as
 intended."
 
 SOURCE  American Academy of Pharmaceutical Physicians