It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.
Dr. Su Golder, NIHR Research Fellow at the University of York, presents findings from her recent publication: “Systematic review on the prevalence, frequency and comparative value of adverse events data in social media”.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Patients Recruitment Forecast in Clinical TrialsCognizant
Inaccurate patient recruitment forecasts for clinical trials cost pharmaceuticals and medical device manufacturers a huge amount of resources each year. We offer descriptions and examples of applying stochastic and non-stochastic approaches to increase accuracy in this crucial stage of drug testing.
Best strategies for successful recruitment and retentionTrialJoin
Best strategies for successful recruitment and retention for clinical research studies
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
Comparative Observational Studies Major types of these designs are cross-sectional studies, case-control studies, and cohort studies (both retrospective and prospective)
Dr. Su Golder, NIHR Research Fellow at the University of York, presents findings from her recent publication: “Systematic review on the prevalence, frequency and comparative value of adverse events data in social media”.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Patients Recruitment Forecast in Clinical TrialsCognizant
Inaccurate patient recruitment forecasts for clinical trials cost pharmaceuticals and medical device manufacturers a huge amount of resources each year. We offer descriptions and examples of applying stochastic and non-stochastic approaches to increase accuracy in this crucial stage of drug testing.
Best strategies for successful recruitment and retentionTrialJoin
Best strategies for successful recruitment and retention for clinical research studies
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
Comparative Observational Studies Major types of these designs are cross-sectional studies, case-control studies, and cohort studies (both retrospective and prospective)
Biostatistics Roles and Responsibilities in Clinical Research | PubricaPubrica
This Presentation explains the Roles and Responsibilities of Biostatistics in clinical research
Biostatistics helps to find answer for research question in Biology, Medicine and Public health
- How a new drug works
- What causes cancer
- what is the reason for many diseases
- How long could a person survive with a particular disease?
Learn More: http://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Contact:
Web: www.pubrica.com
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United kingdom : +44-1143520021
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
Recent advances in patient engagement in research, including patients’ and advocates’ roles in patient
focused-drug development (PFDD) and patient-reported outcomes (PROs).
Biostatistics Roles and Responsibilities in Clinical Research | PubricaPubrica
This Presentation explains the Roles and Responsibilities of Biostatistics in clinical research
Biostatistics helps to find answer for research question in Biology, Medicine and Public health
- How a new drug works
- What causes cancer
- what is the reason for many diseases
- How long could a person survive with a particular disease?
Learn More: http://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Contact:
Web: www.pubrica.com
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United kingdom : +44-1143520021
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
Recent advances in patient engagement in research, including patients’ and advocates’ roles in patient
focused-drug development (PFDD) and patient-reported outcomes (PROs).
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
Chapter 19
Clinical Trials
Clinical Trials
“The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”
— Sidney M. Wolfe
Lecture Overview
Research and Development Investments Fund a Complex Multistage Pathway
Clinical Trials of Generic Drugs
Health Risk Assessments
Expanded Access Protocols
Termination of Clinical Trials
Observational Studies
International Clinical Trials
Informed Consent in General
Transparency and Full Disclosure in Clinical Testing
Financial Conflicts of Interest
Commitment to the Life Sciences
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Clinical trials. In Health care management and the law: Principles and applications (pp. 389-412). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Research and Development Investments Fund a Complex Multistage Pathway
Some major expenses are research materials, advanced computers, and other highly sophisticated machines that support research activities, and salaries of scientists. Stage specific activities include:
Drug discovery
Preclinical testing
Clinical trials
Approval by the FDA
Post marketing surveillance
Research and Development Investments Fund a Complex Multistage Pathway
Drug Discovery:
While most compounds will never be approved for use, each one is evaluated to determine its potential value compared to existing therapies, complexity of large scale manufacturing, and other factors.
Preclinical Testing:
Candidate drugs from the discovery stage receive 1 to 3 years of extensive testing to assess safety and show biological activity against a disease.
Chemical tests establish the purity, stability, and shelf life of a compound.
Manufacturing tests determine mass production of the drug.
Pharmaceutical development studies explore dosing, packaging, and formulation of the drug.
Research and Development Investments
Fund a Complex Multistage Pathway: Clinical Trials
For drugs in development, there are low odds of reaching the market.
While Phase I, II, and III of studies are taking place, research investigators are also conducting toxicity tests and other long-term safety evaluations, evaluating dosage forms, planning for mass production, designing packaging, and preparing the extensive application required for FDA approval.
One out of five drugs that enter clinical testing is never approved by the FDA:
20% of the drugs that enter Phase I are approved to enter Phase II
30% of the drugs that enter Phase II are approved to enter Phase III
60% of the drugs that enter Phase III are approved for a new drug application
80% of the new drug applications are approved by the FDA for market entry
Research and Development Investments Fund a Complex Multistage Pathway
Approval by the U.S. Food and Drug Administration
According to the FDA, the documentation required in a new drug application is supposed to tell the whole story of a ...
Role of Biostatistics in Clinical TrialsClinosolIndia
Biostatistics plays a critical role in clinical trials, providing the analytical framework necessary to ensure that the study is well-designed, accurately executed, and effectively analyzed. Biostatisticians work closely with clinical trial teams to help ensure that the study objectives are clearly defined, that appropriate statistical methods are selected, and that the data is analyzed in a way that is meaningful and accurate.
Some of the key roles that biostatistics plays in clinical trials include:
Study design: Biostatisticians help to design clinical trials by determining appropriate sample size, selecting appropriate endpoints, and defining the statistical analysis plan. This ensures that the study is adequately powered to detect meaningful differences and that the analysis is appropriate for the study design.
Data analysis: Biostatisticians play a critical role in the analysis of clinical trial data. They develop statistical models to evaluate the primary and secondary endpoints of the study, and perform hypothesis testing to determine if the results of the study are statistically significant.
Safety monitoring: Biostatisticians monitor safety data throughout the clinical trial to identify any adverse events or potential safety concerns. This allows the study team to take appropriate action to protect the safety and well-being of study participants.
Reporting: Biostatisticians are responsible for reporting the results of the clinical trial in a clear and accurate manner. They work closely with the study team to develop statistical summaries and to interpret the study results in the context of the overall clinical trial objectives.
Applications of statistics in medical Research and HealthrMuhammadNafees42
This will help you to understand the applications of basic statistics.The application of stat in medical health and research.
#nafeesupdates
#nafeesmedicos
Continuous Flow Chemistry And The Manufacture Of Active Pharmaceutical Ingr...Stuart Silverman
Continuous Flow Chemistry And The Manufacture Of Active Pharmaceutical Ingredients: A Series Of Informative Disquisitions About Continuous Flow Chemistry - Part Four - Quality Assurance and Control Safety
Continuous Flow Chemistry And The Manufacture Of Active Pharmaceutical Ingr...Stuart Silverman
A Series Of Informative Disquisitions About Continuous Flow Chemistry
Part Three:
Translation of flow protocols from the bench to the plant
Reaction Classes
Workup and isolation
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Ind...Stuart Silverman
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Industry Relies Heavily On Sourcing From India & China – India Segment
SPECIAL FOCUS - The environment as a risk to the supply chain.
Security Of The Pharmaceutical Supply Chain Part 4a: The Pharmaceutical Indus...Stuart Silverman
Part 4a: The Pharmaceutical Industry Relies Heavily On Sourcing From India & China – China Segment
Special Focus: The Environment as a Risk To The Supply Chain
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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2. “It is simply no longer possible to believe much of the clinical
research that is published, or to rely on the judgment of trusted
physicians or authoritative medical guidelines. I take no pleasure
in this conclusion, which I reached slowly and reluctantly over
my two decades as an editor of the New England Journal of
Medicine.”
– Dr. Marcia Angell, a physician and longtime editor-in-chief of
The New England Medical Journal (NEMJ)
From The Mouths Of…
3. “The case against science is straightforward: much of the
scientific literature, perhaps half, may simply be untrue.
Afflicted by studies with small sample sizes, tiny effects, invalid
exploratory analyses, and flagrant conflicts of interest, together
with an obsession for pursuing fashionable trends of dubious
importance, science has taken a turn towards darkness.”
Dr. Richard Horton, the current editor-in-chief of The Lancet
From The Mouths Of…
4. “There is increasing concern that most current published research
findings are false.”
• We now have a large amount of evidence, and statements from
experts that come directly from the field, which paint a very
concerning picture. The science used to educate doctors and
develop medicine is flawed.
• We are only ever exposed to studies that have been sponsored by
big pharmaceutical companies, but these studies are not designed
to take the long view.
Dr. Peter Rost, MD, a former vice president of one of the
largest pharmaceutical companies in the world (Pfizer):
From The Mouths Of…
5. “There is increasing concern that most current published research
findings are false.”
• They are not designed to detect problems that can occur years or
even decades after a treatment, or examine the risks of taking a
drug for long periods of time.
• Nobody ever seems to mention or acknowledge the many studies
which clearly show significant risk associated with many of the
products that pharmaceutical companies are manufacturing to
help fight disease.
Dr. Peter Rost, MD, continued:
From The Mouths Of…
6.
7. • What is even more concerning is the general population’s lack
of awareness when it comes to these facts.
• This issue is definitely not going to be addressed in the
mainstream news, and despite plenty of
evidence to support it, some people will
refuse to even look at or acknowledge
that it exists.
• This is a big problem, our world is
changing and we must keep an open
mind and be open to new possibilities
regarding the nature of our world.
Blinded By Science?
8. • It’s 2018, and as we keep moving forward there will be more
information coming out that challenges the deeply held,
engrained belief systems of many.
• It’s okay to look at information that goes
against what you believe, in fact, it’s
needed if we are going to move forward
and create a better world for ourselves.
Blinded By Science?
9. • This is why alternative media is
important, especially in a time where
more and more people are waking up to
what is really happening.
• It’s time to examine the research that’s
being conducted all over the world, from
experts (scientists) at various
institutions, that is not sponsored by
“Big Pharma”
• The independent literature.
• Brilliant work is being published
regarding various drugs, cures,
treatments, vaccines, and more.
Blinded By Science?
10.
11. • A review of routine audits of leukemia trials conducted by the
Cancer and Leukemia Group B, one of the multicenter cancer
clinical trial groups sponsored by the National Cancer Institute,
reported an incidence of fraud of 0.25%
• Similarly, a report of audits in the United Kingdom revealed that
only 0.40% of the contributed datasets were fraudulent
• In the first 10 years of reports from the Office of Research
Integrity, there were 136 findings of scientific misconduct
(again using the PHS definition); 36 (26%) of these were in
clinical trials or other clinical research)
Clin Investig (Lond). 2015; 5(2): 161–173.
12. • A survey of members of the American Association for the
Advancement of Science (AAAS) in which 27% of the scientists
reported having encountered some type of misconduct;
• A survey of research coordinators in which 19% of respondents
reported first-hand knowledge of misconduct within the
previous year – and that only 70% of these were reported;
• A study of Norway medical investigators in which 27% of
investigators knew of instances of fraud;
Surveys of scientists and medical investigators routinely
report high levels of misconduct or knowledge of misconduct
Science. 1992 Mar 27; 255(5052):1636.
Nurs Res. 2010 Jan-Feb; 59(1):51-7.
13. • A survey of members of the International Society of Clinical
Biostatistics, in which over 50% of respondents knew of
fraudulent reports
• A survey of medical institutions in Britain in which more than
50% of respondents knew or suspected misconduct among
institutional colleagues
• A survey of New Scientist readers, in which a remarkable
92% knew of or suspected scientific misconduct by
colleagues
Surveys of scientists and medical investigators routinely
report high levels of misconduct or knowledge of misconduct
Control Clin Trials. 2000 Oct; 21(5):415-27.
Br J Surg. 2000 Dec; 87(12):1605-9.
14. • A survey of NIH-funded scientists in which 33% of respondents
said they had engaged in one or more of a list of ‘top 10’
questionable behaviors ranging from approximately 16% for
‘changing the design, methodology or results of a study in
response to pressure from the funding source’ to 0.3% who
admitted to ‘falsification or ‘cooking’ research data’
• A subsequent similar survey of faculty members of top-tier
research institutions in the United States in which nearly 25%
of respondents admitted to one or more of the ten most serious
types of misconduct during the last 3 years, including 1% who
admitted to fabrication or falsification and over 7% who
admitted to plagiarism
Nature. 2005 Jun 9; 435(7043):737-8.
Acad Med. 2009 Nov; 84(11):1491-9.
Of surveys that directly ask about misconduct by
those being surveyed:
15.
16.
17. “‘There’s no sense in deliberate falsification, anyhow,’
said the Bursar. ‘What could anybody gain by it?’; ’It
has been done,’ said Miss Hillyard, ‘ frequently. To get
the better of an argument. Or out of ambition.’;
‘Ambition to be what?’ cried Miss Lydgate. ‘What
satisfaction could one possibly get out of a
reputation one knew one didn’t deserve? It would be
horrible …I know people do it. But why? They must
be mad.’”
Dorothy L. Sayers, Gaudy Night, 1936.
18. A Lesson From One Of
The Worlds’ Fastest Growing Economies
19. A Lesson From One Of
The Worlds’ Fastest Growing Economies
• China’s top court and prosecutor’s office have released a set of
legal interpretations aimed at tightening the screws on rogue
pharmaceutical companies and public hospitals that have been
falsifying data to get licenses for new drugs
• Researchers convicted of falsifying data in studies or
clinical trials for new medications could face up to 10
years in prison
Caixin - Aug 16, 2017
20. A Lesson From One Of
The Worlds’ Fastest Growing Economies
• The administration ordered the pharmaceutical companies
behind 1,622 drugs in line for regulatory approval to conduct
a monthlong review of their new product applications for
potentially fraudulent data in studies and trials
• The administration promised not to punish companies that
uncovered misconduct in their own reviews
• After the month was over, the pharmaceutical companies
had withdrawn their applications for one-fifth of the listed
drugs, including 948 new drugs, 503 generic medications
and 171 imported drugs, according to the CDFA
• By the end of June 2016, the pharmaceutical companies had
withdrawn nearly half their applications
Caixin - Aug 16, 2017
21. Conflicts of Interest at Medical Journals:
The Influence of Industry-Supported Randomized Trials on Journal
Impact Factors and Revenue
22. Conflicts of Interest at Medical Journals
• Publication of industry-supported trials is associated with
an increase in journal impact factors.
• Sales of reprints may provide a substantial income.
• Journals should disclose financial information in the same
way that they require them from their authors, so that
readers can assess the potential effect of different types of
papers on journals’ revenue and impact.
23. • The proportion of trials with sole industry support varied
between journals. Industry supported trials were more
frequently cited than trials with other types of support
• Interestingly, industry trials more often have positive results
than non-industry trials.
• The conclusions in negative trials are often presented in
such a way that they appear to be more positive than they
actually were.
• Positive industry trials are more cited than negative ones
Conflicts of Interest at Medical Journals
Lundh A, Barbateskovic M, Hro ́bjartsson A, Gøtzsche PC (2010) Conflicts of Interest at Medical Journals: The Influence of Industry-
Supported Randomized Trials on Journal Impact Factors and Revenue – Cohort Study. PLoS Med 7(10): e1000354.
doi:10.1371/journal.pmed.1000354
24. Conflicts of Interest at Medical Journals
• Sponsoring companies employ various strategies to increase
the awareness of their studies, including ghost authored
reviews that cite them, purchase and dissemination of reprints,
and creation of media attention.
• Such strategies are likely to be predominantly used for trials
favorable to the sponsors’ products, and this may put editors
under pressure, as they know which papers are especially
attractive for the companies
Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic
review. BMJ 326: 1167–1170.
Boutron I, Dutton S, Ravaud P, Altman DG (2010) Reporting and interpretation of randomized controlled trials with statistically
nonsignificant results for primary outcomes. JAMA 303: 2058–2064.
26. Medical Journals Have Become An Extension of
Pharmaceutical Companies
“Journals have devolved into information laundering
operations for the pharmaceutical industry”,
- wrote Richard Horton, editor of The Lancet,
in March 2004
• Up to 75% of clinical trials published in
major journals like JAMA, Lancet, NEJM,
and Annals of Internal Medicine are
industry-sponsored
PLoS Medicine October 2010 | Volume 7, Issue 10
27. Big Pharma spends about $500 million every year placing ads
about their drugs in medical journals.
• Up to 1/3 of the pages in an average medical journal are full
page ads.
• If you’re trying to sell more drugs, it does make sense to
advertise in these journals, because those who will prescribe
these drugs read these journals.
• Return on investment for journal drug ads is estimated to be
an impressive $5 for every $1 that a drug company spends on
these ads.
“Journals have devolved into information laundering
operations for the pharmaceutical industry.”
PLoS Medicine October 2010 | Volume 7, Issue 10
28. 75 percent of what is being published today in journals like
Annals of Internal Medicine, the Journal of the American
Medical Association (JAMA), The Lancet and the New England
Journal of Medicine (NEJM) are trials that have been directly
funded by industry.
“Journals have devolved into information
laundering operations for the pharmaceutical
industry.”
PLoS Medicine October 2010 | Volume 7, Issue 10
29. “The companies seem to get the results they want not by fiddling with
the results, but by the very nature of the studies”
These include:
• Conducting a trial of a given drug against a treatment known to
be inferior
• Conducting a trial against too low of a dose of a competitor drug
• Conducting a trial against too high of a dose of a competitor drug,
making the drug in question seem less toxic
• Conducting a trial that is too small to show differences from
competitor drugs
Institute of Medicine, National Academy of Sciences, National Academy of Engineering. On Being a Scientist: A Guide to Responsible Conduct in Research. 3. The National
Academies Press; Washington, DC, USA: 2009
Nothing Up My Sleeve
30. • Using multiple endpoints in a trial and selecting for
publication only those that provide favorable results
• Conducting multi-center trials and selecting for publication
only those that reach favorable results
• Conducting subgroup analyses and selecting for publication
only those that are favorable
• Presenting results that are most likely to impress, such as
showing a reduction in relative as opposed to absolute risk
These include (continued):
Institute of Medicine, National Academy of Sciences, National Academy of Engineering. On Being a Scientist: A Guide to Responsible Conduct in Research. 3. The National
Academies Press; Washington, DC, USA: 2009
Nothing Up My Sleeve
31. Thursday, May 28, 2015 by: Jonathan Benson
It's not so much drug advertising as it is sponsored trials that
corrupt medical journals
• Although pharmaceutical advertising renders the quality of
what's been published in a given medical journal questionable,
at least readers of that journal can see these advertisements
and determine how seriously to take the contained studies.
• However, when the studies themselves are industry sponsored
and this is not disclosed, things get messy.
32. "A large trial published in a major journal has the journal's stamp
of approval (unlike the advertising), will be distributed around the
world, and may well receive global media coverage, particularly
if promoted simultaneously by press releases from both the
journal and the expensive public relations firm hired by the
pharmaceutical company that sponsored the trial.”
Scrip Magazine. 1993;14(March):14–15.
33. • For a drug company, a favorable trial is worth thousands of pages
of advertising, which is why a company will sometimes spend
upwards of a million dollars on reprints of the trial for worldwide
distribution.
• The doctors receiving the reprints may not read them, but they
will be impressed by the name of the journal from which they
come.
• The quality of the journal will bless the quality of the drug.
Scientist. 1995;20:13.
34. • Journals have thus far been accepted as one of the most
trusted sources of information
• It’s clear, however, that in order to maintain that trust,
journals and editors need to continue to consider all the
pressures that can arise in publishing and put in place robust,
transparent procedures for handling all the potential conflicts
that can arise, whether they are those of authors, editors, or
the journals themselves
Journal Cell Biology, 179, 1091-1092