Why was early therapeutic research on psychedelic drugs abandoned?

2021 ◽  
pp. 1-6
Author(s):  
Wayne Hall

Abstract Background Advocates of the therapeutic use of psychedelic drugs have argued that a promising approach to treatment was prematurely abandoned in the 1960s primarily because of Richard Nixon's ‘War on Drugs’. This paper (1) briefly describes research in the 1950s and 1960s in North America on the use of LSD to treat alcohol dependence, anxiety in terminal illness, and anxiety and depression; and (2) discusses the factors that led to its abandonment. Method An analysis of historical scholarship on psychedelic research in the 1950s, 1960s and 1970s in North America. Results Research on psychedelic drugs in psychiatry was abandoned for a number of reasons that acted in concert. A major factor was that clinical research on psychedelic drugs was caught up in the tighter regulation of pharmaceutical research after the Thalidomide disaster in 1963. Psychedelic drugs also presented special challenges for randomised, placebo-controlled clinical trials in the 1970s that were not as positive as the claims made by their advocates in the 1950s and 1960s. Clinical research became more difficult after 1965 when Sandoz ceased providing psychedelic drugs for research and their nonmedical use was prohibited in 1970. Conclusions The demise of psychedelic drug research was not solely due to the ‘War on Drugs’. It was hastened by tighter regulation of pharmaceutical research, the failure of controlled clinical trials to live up to the claims of psychedelic advocates, and the pharmaceutical industry's lack of interest in funding clinical trials.

2012 ◽  
Vol 21 (4) ◽  
pp. 234-241 ◽  
Author(s):  
Martha A. Q. Curley

Clinical inquiry is the ongoing process of questioning and evaluating practice, providing informed practice based on best-available data, and innovating practice though research. It is about noticing subtle differences at the bedside and asking “what if” questions. Critically ill patients and their families require care that is based on our best-available evidence. In the quantitative research paradigm, the highest level of evidence is derived from randomized controlled clinical trials. Currently, few adequately powered clinical trials support our practice, but this is changing. In critical care, clinical research should be conducted in the same manner as we practice, collaboratively within multidisciplinary teams. Our core value of the primacy of patient and family, our spirit of inquiry, and our passion for innovation centers our practice. During this year’s Distinguished Research Lecture, Martha Curley describes how together, we can build stronger, bolder clinical research.


2008 ◽  
Vol 19 (2) ◽  
pp. 164-169
Author(s):  
Sharon Y. Irving ◽  
Martha A.Q. Curley

Nursing care provided to patients and their families should be based on strong scientific evidence. In the quantitative research paradigm, the highest level of evidence is derived from conclusive randomized controlled clinical trials. Multicenter clinical research allows the accrual of sufficient numbers of diverse participants in a shorter period of time and improves the generalizability of the study findings. Clinical research is inherently complex; the complexity exponentially increases when conducting multicenter clinical trials. Investigators are challenged to maintain the internal validity of the study and the sustained commitment and collaboration of numerous disciplines over the study period. This article presents 10 essential points to consider when conducting multicenter clinical research.


2020 ◽  
pp. OP.20.00501
Author(s):  
Carrie Lee ◽  
Theresa L. Werner ◽  
Allison M. Deal ◽  
Cassandra J. Krise-Confair ◽  
Tricia Adrales Bentz ◽  
...  

PURPOSE: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap. METHODS: An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate). RESULTS: The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation. CONCLUSION: The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.


2021 ◽  
Vol 17 (2) ◽  
pp. 5-24
Author(s):  
Daria Jadreškić

The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is historical. The development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6633-6633 ◽  
Author(s):  
B. George ◽  
S. Simhan ◽  
J. A. Lee ◽  
M. A. Mathiason ◽  
R. S. Go

6633 Background: The integrity of scientific and clinical research is dependent on the avoidance of conflicts of interest (COI). Hence, the American Society of Clinical Oncology (ASCO) has implemented a COI policy pertaining to articles published in the Journal of Clinical Oncology (JCO). In this study, we examined the prevalence and nature of COI among scientific articles published in JCO. Methods: We reviewed original articles, review articles and ASCO special articles published in JCO from August 2005 to January 2006. COI was categorized into employment/leadership position, consultancy, stock ownership, honoraria, research funding, expert testimonials and other remuneration. Results: Out of a total of 514 articles reviewed, original articles, review articles and ASCO special articles comprised 88.3%, 11.1% and 0.06% respectively. Overall 34.8% of the articles reported at least 1 COI. Among articles with COI, 21.8%, 27.4% and 50.8% reported 1, 2 and 3 or more COI, respectively. Consultancy (64.8%) was the most common COI, followed by honoraria (64.2%), research funds (58.7%), employment/leadership (40.2%), stock ownership (39.7%), testimonials (11.2%) and other remuneration (10.1%). COI was reported in 58.3% of clinical trials compared to 24.6% in other articles (P = 0.001). Out of the total of 4,944 authors, 14.0% reported a COI. Among authors with COI, 47.9%, 38.2% and 13.9% reported 1, 2 and 3 or more COI, respectively. The prevalence of COI among articles originating from North America, Europe and Asia/Australia were 38.2%, 31.8% and 13.8%, respectively (P = 0.020). Conclusions: COI were widely prevalent in articles published in JCO. Clinical trials had a higher prevalence of COI compared to other scientific articles. The prevalence of COI was equally high in articles originating from North America and Europe, but much lower in articles from Asia/Australia. The majority of reported COI were unrelated to research funds. No significant financial relationships to disclose.


1987 ◽  
Vol 42 (12) ◽  
pp. 1132-1133
Author(s):  
Stanley D. Imber ◽  
Lawrence M. Glanz ◽  
Irene Elkin ◽  
Stuart M. Sotsky ◽  
Jenny L. Boyer ◽  
...  

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