The fascinating history of clinical trials

From the June 3, 2020 article at The Conversation

“Clinical trials are under way around the world, including in Australia, testing COVID-19 vaccines and treatments.

These clinical trials largely fall into two groups. With observational studies, researchers follow a group of people to see what happens to them. With experimental studies, people are assigned to treatments, then followed. 

These study designs have come about from centuries of people trying out different ways of treating people.

Here are some of the key moments in the history of clinical trials that led to the type of trials we see today for COVID-19.”

Continue reading the article for examples as ginseng in China, rhubarb in 18th century England, Early 20th-century randomised trial, and tuberculosis and the randomised controlled trial

Additional resources and reading

—Randomised control trials: what makes them the gold standard in medical research?

–From the research lab to your doctor’s office – here’s what happens in phase 1, 2, 3 drug trials

— Health Check: can vitamins supplement a poor diet?

—ClinicalTrials.gov – a searchable database of privately and publicly funded clinical studies conducted around the world.

[Press release] MD Anderson and Bayer collaborate to create symptom assessment questionnaires in clinical trials

MD Anderson and Bayer collaborate to create symptom assessment questionnaires in clinical trials 

From the press release

MD Anderson News Release 1/23/2015

When cancer patients take part in a clinical trial to develop new therapies, they and their physicians want to know how they will feel and function during treatment. A new collaboration between Bayer and The University of Texas MD Anderson Cancer Center will go straight to the patients to learn how certain investigational new drugs affect them. The project will involve the use of questionnaires to assess how a drug may impact a patient’s disease-related symptoms.

“Fit-for-purpose patient-reported-outcome (PRO) measures are an invaluable resource for helping us to better understand how patients are actually being affected by new therapies,” said Charles Cleeland, Ph.D., chair of symptom research at MD Anderson. “This will be especially important in the developmental pathway of new drugs, given that these PRO measures will enhance information about treatment tolerability and potential symptom-reduction benefit earlier in the drug development process.”

Charles Cleeland, Ph.D.

The information will be beneficial in further evaluating the drug if it progresses to later stages of clinical development and is tested in larger numbers of patients. The importance of having data on the symptom burden or benefit conferred by therapy is often not recognized until late in that process.

“For patients and their physicians, knowing the probable effects of a treatment can help with decisions among treatment options when therapeutic outcomes are similar but symptomatic effects are not,” said Cleeland.

…

 Related Resources

• ClinicalTrials.gov
  • registry and results database of publicly and privately supported clinical studies of human participants conducted around the world

  • What Information Can I Find on ClinicalTrials.gov?

    Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:

    • Disease or condition
    • Intervention (for example, the medical product, behavior, or procedure being studied)
    • Title, description, and design of the study
    • Requirements for participation (eligibility criteria)
    • Locations where the study is being conducted
    • Contact information for the study locations
    • Links to relevant information on other health Web sites, such as NLM’s MedlinePlus® for patient health information and PubMed® for citations and abstracts for scholarly articles in the field of medicine.

    Some records also include information on the results of the study, such as:

    • Description of study participants (the number of participants starting and completing the study and their demographic data)
    • Outcomes of the study
    • Summary of adverse events experienced by study participants
  • More information at ClinicalTrials.gov
    • Learn about clinical trials
    • MedlinePlus® Clinical Trials Information

      MedlinePlus is a Web-based health information service of the National Library of Medicine. It explains health topics using language that is easy to understand. Visit the Clinical Trials page (also available in Spanish) or the interactive tutorial on clinical trials (also available in Spanish) to learn more about clinical research and find answers to common questions.

Related articles

• MD Anderson and Bayer Announce Collaboration to Create Symptom Assessment Questionnaires in Clinical Trials
• Drug Development’s Long And Winding Road