Mobile Devices Support Clinical Trials of Chronic Musculoskeletal Pain

MedicalResearch.com Interview with:

Richard L Kravitz, MD, MSPH Professor, General Internal Medicine Director, UC Center Sacramento

Dr. Kravitz

Richard L Kravitz, MD, MSPH
Professor, General Internal Medicine
Director, UC Center Sacramento

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response:  The study was designed to address tso problems. The first is that many patients with chronic pain struggling to find a workable regimen.

The second is more general. Patient sometimes I hesitate to participate in clinical research because they right away do not see the relevance I directly to them selves. And have one trials are away I’m addressing both problems.  Continue reading

Overlapping Regulations Can Impede Transparency in Medical Research Trials

MedicalResearch.com Interview with:

Trudo Lemmens (LicJur, LLM bioethics, DCL) Professor and Scholl Chair in Health Law and Policy Faculty of Law, University of Toronto Toronto Ontario, Canada

Prof. Lemmens

Trudo Lemmens (LicJur, LLM bioethics, DCL)
Professor and Scholl Chair in Health Law and Policy
Faculty of Law, University of Toronto
Toronto Ontario, Canada 

MedicalResearch.com: What is the background for this study?

Response: The study is part of a series of articles organized in collaboration between the BMJ and the Pan American Health Organization, with particular involvement of members of PAHO’s Advisory Committee on Health Research.

The goal of the series is to highlight some of the key accomplishments in the PAHO region in the last decades following PAHO’s 2009 regional policy on research for health, the first WHO regional policy that aimed at contributing to WHOs Stragegy on Research for Health.

One of the issues that have been identified in the last decades as an important challenge, particularly for research related to pharmaceutical product and medical device development, is the lack of transparency of clinical trials data. This has been associated with problems of hiding and misrepresentation of research results, duplication of research, and misleading or even outright fraudulent presentations of findings in medical publications.

Various remedies have been proposed to address these problems, from trial registration, to results reporting, to broader data sharing that enables independent researchers to verify and challenge research results. I have been involved through PAHO and in my own research in the promotion of transparency measures at the national and international level. PAHO has been playing a leading role in this in the region, so it seemed more than fitting to have an article in the series on what has been accomplished and what challenges remain.

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Improving Adjuvant Clinical Trials By Including Only Patients For Whom Current Therapies Do Not Work Well

MedicalResearch.com Interview with:

Lajos Pusztai, M.D, D.Phil. Professor of Medicine Director of Breast Cancer Translational Research Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program Yale School of Medicine New Haven, CT  06511

Dr. Pusztai

Lajos Pusztai, M.D, D.Phil.
Professor of Medicine
Director of Breast Cancer Translational Research
Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program
Yale School of Medicine
New Haven, CT  06511

MedicalResearch.com: What is the background for this study?

Response: Overall, about 85% of newly diagnosed stage I-III breast cancer patients will not die of their disease, and this roughly equates to an 85% cure rate. Of course cure rates are higher for stage I cancers and lower for stage III cancers. An 85% overall cure rate is good but not good enough, we continuously try to develop new therapies hoping to push these rates to 90%…,95%…etc. However, it is not possible to cure a patient twice over. For example, if surgery plus endocrine therapy cures all patients, the addition of chemotherapy cannot improve on it no matter how effective it is. If surgery plus endocrine therapy cures 95%, adding the perfect chemo to this treatment can only bring about a 5% improvement, and very good chemo that would push cure from 95% to 97%, would require a very large trial including many thousands of patients.

This is an increasingly common scenario in modern breast cancer adjuvant trials (where the goal is to improve survival and cure); the control arm that receives the current standard of care invariably does better than expected and the experimental arm only improves outcome by 1-3% that does not reach statistical significance.  The painful conclusion from these trials is that we do not know if the new drug actually works or not because there were not enough events to demonstrate an effect.

Of course, a lot of patients in the study were also exposed to a new drug with all of its associated toxicities who could not possibly benefit from it.

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Physicians Should Be Critical of Adverse Event Reporting in Clinical Trials

MedicalResearch.com Interview with:

Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department  IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy

Dr. Paolo Bossi

Paolo Bossi MD
Medical Oncologist
Head and Neck Cancer Department
IRCCS Istituto Nazionale dei Tumori Foundation
Milan, Italy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs.

It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs.
However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities.

This line of reasoning is particularly true for new or “relatively new” drugs, such as immunotherapy (IT) and targeted agents (TT).

So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database.

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Variability of Biomarkers Used In Clinical Trials May Cloud Outcomes

Alan H.B. Wu, PhD, DABCC Professor Laboratory Medicine Chief, Clinical Chemistry Laboratory University of California San Francisco, CAMedicalResearch.com Interview with:
Alan H.B. Wu, PhD, DABCC

Professor Laboratory Medicine
Chief, Clinical Chemistry Laboratory
University of California San Francisco, CA

Medical Research: What is the background for this study? What are the main findings?

Response: Clinical trials are conducted for validation of novel biomarkers.  There is considerable heterogeniety in the quality design and documentation of findings. This can have a major impact on the conclusions rendered.

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Clinical Trial Enrollment: Racial & Ethnic Enrollment Differences

Aisha T. Langford, PhD, MPH Postdoctoral Fellow VA Health Services Research and Development Service (HSR&D & U-M Center for Bioethics and Social Sciences in Medicine (CBSSM) 2800 Plymouth Road, NCRC Building 16, Room 400S-15 Ann Arbor, MI 48109MedicalResearch.com Interview with:
Aisha T. Langford, PhD, MPH
Postdoctoral Fellow
VA Health Services Research and Development Service & U-M Center for Bioethics and Social Sciences in Medicine
Ann Arbor, MI 48109

MedicalResearch.com: What are the main findings of the study?

Dr. Langford: The main and perhaps most interesting finding was that there were no racial/ethnic differences in cancer clinical trial enrollment, refusal rates, or “no desire to participate in research” as the reason given for clinical trial refusal; however, patients over the age of 65 had lower odds of being enrolled in a clinical trial. Additionally, higher odds of having physical/medical conditions were associated with older age, males, and non-Hispanic blacks.
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