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The History of Change within Clinical Trials

10 Principles That Shaped Clinical Trials

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How much do you really know about the history of clinical trials? Clinical trials these days are complex and designed to protect human participants, however, they were not always this way. Throughout history, it has been an uphill battle to fight for human protection within the clinical trial space. You may think that this should have been important, however, determining whether the benefit outweighed the risk was hard to decipher during a time when the advancement of medical research was moving so quickly. Now, this is NO excuse for infringing upon human rights, which is why, there has been the development of guidelines, standards, and protocols to help direct clinical trial research on how to protect participants, while still advancing medical research.                                                                                                                                                                                                        Photo Source.

Major Influences for Change

Important documents and events shaped the clinical trial world we know today.Documents such as The Nuremberg Code, The Declaration of Helsinki, and The Belmont Report all provide insight into the importance of protecting human participants. Events, better referred to as clinical trial atrocities, such as the Tuskegee Syphilis Study, led to further much needed change.

Let’s dive into each of them.

The Nuremberg Code

Between 1946 and 1947, in Nuremberg, Germany, a group of American judges sat in on a series of trials to decide the fate of Nazi doctors. These trials are now referred to as “The Doctor’s Trial” since 23 physicians from the German Nazi Party were tried for their participation in atrocious human experiments within concentration camps during WWII. The verdict of these trials led to the creation of The Nuremberg Code, which is a set of ten ethical principles necessary for human experimentation. The 10 principles include:

  1. Voluntary Consent
  2. Experimental results must be for the greater good of society
  3. Human experiments should be based on previously completed animal experiments
  4. Physical and Mental suffering and injury should be avoided within experimentation
  5. No experiment should be conducted if it is thought to cause death or disability
  6. The risk of the experiment should never outweigh the benefits
  7. Adequate facilities need to be used to protect participants
  8. Only qualified scientists should be conducting experiments
  9. Participants should be able to end their participation at any time
  10. If injury, disability, or death are likely to occur, the scientist in charge must be prepared to terminate the experiment

The Nuremberg Code commenced the initiation of other documents that expand upon the 10 principles above, keeping in mind the same goal: to conduct ethical clinical trials and protect human participants.

Picture1-4Photo from The Doctor’s Trials

The Declaration of Helsinki

Originally developed in 1964 by the World Medical Association (WMA) in Helsinki, Finland, The Declaration of Helsinki serves as another guide to protect humans within clinical research. Although it is not a legally binding document, parts of it have been put into many laws that govern medical research across the world. Both the Nuremberg Code and the Declaration of Geneva (which outlined physicians ethical duties and focused on the health of the patient and the importance of not using medical knowledge to violate human rights) influenced the creation of the Declaration of Helsinki. The Declaration is mainly addressed to physicians, encouraging them to promote the health of patients. Outlining quite a few more principles than the Nuremberg Code, The Declarations main goals were to:

  • Enforce respect for individuals
  • Enable participants right to make informed decisions
  • Recognition of vulnerable groups
  • Researchers’ roles and responsibilities when it comes to protecting human subjects

Throughout history, the Declaration has undergone six revisions (1975, 1983, 1996, 2000, and 2008) to remain current and reflect the ever-changing world of biomedical research.

Finlandia Hall, the venue for the Declaration of Helsinki conference 

The Belmont Report

Written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report, published in 1976, took over 4 years of meetings to create.The Commission was asked to identify basic ethical principles that should be modelled while conducting biomedical and behavioral research that involve human subjects. Once they identified these principles, they were asked to develop guidelines that should be followed while conducting such research. Therefore, they developed The Belmont Report which focuses in on three ethical principles: respect of persons, beneficence, and justice.

The Belmont Report

The Tuskegee Syphilis Study

Originally called the “Tuskegee Study of Untreated Syphilis in the Negro Male”, the Tuskegee Syphilis Study enrolled 600 back men. The participants were told that they were being treated for a condition called “bad blood”, a term at the time that meant they had multiple illnesses, including syphilis. Part way through the study, penicillin (a treatment for syphilis) became easily available to the public, however it was not offered to the participants in the study. The study continued to go on, leaving the participants untreated, neglected, untruthfully informed about the intentions of the study, and without an option to leave the study.

In 1972, a press story was released about how ethically unjustified the study was, finally causing the study to end. A class-action lawsuit on behalf of the study participants and their families was filed in 1973, in which they got $10 million as a settlement. More than 20 years later, President Bill Clinton finally issued a formal presidential apology on behalf of the United States.

Other Moments in Time

Beyond these most historically notable evens and documents, there have been other disastrous moments in clinical trial history that have disproportionality effected marginalized communities.

Inmates have been commonly taken advantage of in clinical research. Their participation in research raises concern about pressures or coercion to participate. Therefore, protocols and protections are now in place to protect prisoners.

Those who have lack of access to health care services, have also historically been at an increased risk of being exposed to the risks and burdens of clinical trials without realizing it. There are now mechanisms to ensure that low- and middle-income countries are not exploited to protect high-income countries.

Moments Moving Forward

While the clinical trial space has advanced astronomically, there are still areas within healthcare that can be improved such as access and dismantling exclusivity. Power of Patients’ overarching goal is to reshape and accelerate clinical trials for individuals with Traumatic Brain Injuries (TBI), while empowering patients.

Clinicians have difficulties diagnosing patients and prescribing effective therapeutics. This issue stems from a lack of knowledge within the medical community and research industry. Clinical trials in this space are falling behind because brain injuries are complex, intricate, complicated, and unique to every patient. Power of Patients can change this. Sallie® is designed to help brain injury patients drive change.

 “Progress is impossibly without change, and those who cannot change their minds cannot change anything.” – George Bernard Shaw

Be sure to register for Sallie®, to monitor and track your TBI symptoms, while also contributing to change within the TBI clinical trial space.

Register here.