Clinical trials impact your community. They help enhance health outcomes by developing treatments and therapies that contribute to increased understanding of diseases and how to treat them, fight them or even eradicate them.
Clinical research champions are united in their passion
for getting more people involved in research studies.
This is your space for materials to help you communicate about clinical trials and their impact in your community.
If you are a community or business leader, an advocacy group, a non-profit organization, or a clinical trials champion, you are welcome to use the resources in this tool kit to help develop awareness about clinical trials and clinical trial participation.
Clinical studies have led to major changes in how clinical trials are conducted in order to protect the rights, safety, and welfare of patients in clinical trials. The mistakes of the past have led to the increased protection of participants and their welfare.
Sulfonamide (sulfa drugs) were the first systemic antibiotics. The drug was widely available as the patent had expired. As a result, manufacturers produced immense amounts of sulfa with no testing requirements. Adults and children died from sulfa medicine in 1937.
The Federal Food, Drug, and Cosmetic Act was created in response to the sulfa craze. The Act required drugs to be proven safe, and authorized factory inspections before being marketed to the public.
From 1939 to 1945, the Nazi's performed experiments on concentration camp prisoners. These experiments were unscientific and conducted without consent. The trials concluded in August 1947. The physician defendants were charged with murders, tortures, and other atrocities committed in the name of medical science and was sentenced to death by hanging.
In May 1947 during the Nuremburg Trials legitimate medical research was defined by a six- point document to the Counsel for War Crimes. The Code includes but is not limited to informed consent, absence of coercion, beneficence toward study participants, etc.
Durham-Humphrey Amendment defined two types of mediations: prescriptions and over-the- counter (OTC). This bill defined prescription drugs as those that are unsafe for self-medication.
The Declaration of Helsinki (DoH) addressed clinical research practices and new, relaxed, guidelines for conditions of consent. The World Medical Association adopted the DoH and have revised this document several times since the first version
The Tuskegee Study of Untreated Syphilis in the Negro Male started in 1932. In the Center for Disease Control (CDC) recommended that the study continue in 1969, despite knowing that penicillin was the standard treatment for syphilis patients. Study participants were not informed about the option of penicillin as a treatment. The program finally ended in 1972, after whistleblower leaked information about the study to the press.
The National Commission published the Belmont report in 1979. The main principles in the Belmont Report include respect for persons, beneficence, and justice.
The Modernization Act enabled the broadest reform in FDA practices since 1938. Reforms included increased patient access to experimental drugs and medical devices, and accelerated the review time for drug approval from 30 months to 15 months.
