Clinical trials physician

Stat Med. Baseline characteristics of participants in the Physicians' Health Study: a randomized trial of aspirin and beta-carotene in U.

Am J Prev Med. J Clin Endocrinol Metab. A prospective study of plasma homocyst e ine and risk of myocardial infarction in US physicians. Low-dose aspirin and subsequent peripheral arterial surgery in the Physicians' Health Study. Comparison of delay times to hospital presentation for physicians and nonphysicians with acute myocardial infarction. Am J Cardiol.

Baseline fibrinolytic state and the risk of future venous thrombosis. A prospective study of endogenous tissue-type plasminogen activator and plasminogen activator inhibitor. A prospective study of exercise and incidence of diabetes among US male physicians. Arterioscler Thromb. A prospective study of lipoprotein a and the risk of myocardial infarction. Height and incidence of cardiovascular disease in male physicians. Endogenous tissue-type plasminogen activator and risk of myocardial infarction.

Prospective study of endogenous tissue plasminogen activator and risk of stroke. Cigarette smoking and stroke in a cohort of U.

Ann Intern Med. The use of vitamin supplements and the risk of cataract among US male physicians. Am J Public Health. Hennekens CH, Eberlein K. A randomized trial of aspirin and beta-carotene among U. Prev Med. The 2 x 2 factorial design: its application to a randomized trial of aspirin and carotene in U. Final report on the aspirin component of the ongoing Physicians' Health Study. Methodologic considerations in the design and conduct of randomized trials: the U. Physicians' Health Study. Control Clin Trials.

Cost and efficiency in clinical trials: the U. Low-dose aspirin for migraine prophylaxis. Circadian variation of acute myocardial infarction and the effect of low-dose aspirin in a randomized trial of physicians.

Aspirin in the primary prevention of angina pectoris in a randomized trial of United States physicians. Am J Med. Biochemical markers of compliance in the Physicians' Health Study. Clinical characteristics of nonfatal myocardial infarction among individuals on prophylactic low-dose aspirin therapy.

Methylenetetrahydrofolate reductase polymorphism, plasma folate, homocysteine, and risk of myocardial infarction in US physicians. A prospective study of triglyceride level, low-density lipoprotein particle diameter, and risk of myocardial infarction. A prospective study of plasma fish oil levels and incidence of myocardial infarction in U. J Am Coll Cardiol. Mutation in the gene coding for coagulation factor V and the risk of myocardial infarction, stroke, and venous thrombosis in apparently healthy men.

A prospective evaluation of an angiotensin-converting-enzyme gene polymorphism and the risk of ischemic heart disease. A prospective study of alcohol consumption and risk of cataract. Plasma concentration of cross-linked fibrin degradation product D-dimer and the risk of future myocardial infarction among apparently healthy men. Adherence to aspirin in the prevention of myocardial infarction. The Physicians' Health Study. Arch Intern Med. Dehydroepiandrosterone sulfate and the risk of myocardial infarction in US male physicians: a prospective study.

Am J Epidemiol. A prospective study of plasma hormone levels, nonhormonal factors, and development of benign prostatic hyperplasia.

A prospective evaluation of plasma prostate-specific antigen for detection of prostatic cancer. Migraine and subsequent risk of stroke in the Physicians' Health Study.

Allow cookies Save Settings. Where Are Clinical Studies Conducted? How Are Participants Protected? Clinical Trials In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. Observational Studies In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Who Conducts Clinical Studies? Reasons for Conducting Clinical Studies In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions.

Some common reasons for conducting clinical studies include: Evaluating one or more interventions for example, drugs, medical devices, approaches to surgery or radiation therapy for treating a disease, syndrome, or condition Finding ways to prevent the initial development or recurrence of a disease or condition.

These can include medicines, vaccines, or lifestyle changes, among other approaches. Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition Examining methods for identifying a condition or the risk factors for that condition Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness Participating in Clinical Studies A clinical study is conducted according to a research plan known as the protocol.

It contains the following information: The reason for conducting the study Who may participate in the study the eligibility criteria The number of participants needed The schedule of tests, procedures, or drugs and their dosages The length of the study What information will be gathered about the participants Who Can Participate in a Clinical Study?

Relationship to Usual Health Care Typically, participants continue to see their usual health care providers while enrolled in a clinical study. Considerations for Participation Participating in a clinical study contributes to medical knowledge.

Questions to Ask Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses.

What is being studied? Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before? What are the possible interventions that I might receive during the trial? How will it be determined which interventions I receive for example, by chance?

Who will know which intervention I receive during the trial? Will I know? Will members of the research team know? How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?

What will I have to do? What tests and procedures are involved? How often will I have to visit the hospital or clinic? Will hospitalization be required? How long will the study last? Who will pay for my participation? Will I be reimbursed for other expenses? What type of long-term follow-up care is part of this trial? If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?

Will results of the study be provided to me? Who will oversee my medical care while I am participating in the trial? References 1. American College of Cardiology Foundation. The clinician as investigator: participating in clinical trials in the practice setting. Editorial: best evidence medical education: the simple truth. Med Teach. Best evidence medical education BEME : a plan for action.

Factors influencing the participation of gastroenterologists and hepatologists in clinical research. Recruitment to a prospective breast conservation trial: why are so few patients randomised?

Fam Pract. Department of Health. J Clin Oncol. Br J Cancer. DeMaria AN. Clinical investigation … an impending crisis? J Am Coll Cardiol. Eastman P. Fertil Steril. A systematic review highlights threats to validity in studies of barriers to cancer trial participation.

J Clin Epidemiol. Baum M. The ATAC Arimidex, Tamoxifen, Alone or in Combination adjuvant breast cancer trial in postmenopausal patients: factors influencing the success of patient recruitment.

Eur J Cancer. Barriers to participation in randomised controlled trials: a systematic review. The recruitment of research participants: a review.

Soc Work Health Care. Clinical research and the physician- patient relationship. Ann Intern Med. CRD Report Clinician perspectives on participation in research. J Midwifery Womens Health. Barriers to participation in randomized clinical trials for early breast cancer among Australian cancer specialists.

Aust N Z J Surg. View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area. Int Arch Med. A survey of attitudes toward clinical research among physicians at Kyoto University Hospital.

BMC Med Educ. Improving accrual into cancer clinical trials. J Cancer Educ. Conducting clinical research in the new NHS: the model of cancer. Dickinson CJ. Clinical research in the NHS today. J R Coll Physicians Lond. Clinical trials in cancer therapy: efforts to improve patient enrollment by community oncologists. Med Pediatr Oncol. The impact of disease severity on the informed consent process in clinical research. Am J Med. N Engl J Med.

Taylor KM, Kelner M. Interpreting physician participation in randomized clinical trials: the Physician Orientation Profile.

J Health Soc Behav. Taylor KM. Physician participation in a randomized clinical trial for ocular melanoma. Ann Ophthalmol. Fundamental dilemmas of the randomized clinical trial process: results of a survey of the 1, Eastern Cooperative Oncology Group investigators.

Randomised clinical trials in general practice: lessons from a failure. Enrollment in clinical trials: institutional factors affecting enrollment in the cardiac arrhythmia suppression trial CAST Control Clin Trials. Issues of recruitment, retention, and compliance in community-based clinical trials with traditionally underserved populations. Appl Nurs Res.

Maslin-Prothero SE. Physician response to informed consent regulations for randomized clinical trials. Integrating conflicting professional roles: physician participation in randomized clinical trials. Soc Sci Med. Doctor—patient communication about breast cancer adjuvant therapy.

An evaluation of physician determinants in the referral of patients for cancer clinical trials in the community setting. Prog Clin Biol Res. Selection bias in clinical trials. Gawlinski A. Am J Crit Care. Factors that limit the quality, number and progress of randomised controlled trials.

Health Technol Assess. Investigator barriers and preferences to conduct clinical drug trials in Finland: a qualitative study. Pharm World Sci. Prevalence and determinants of physician participation in conducting pharmaceutical-sponsored clinical trials and lectures. J Gen Intern Med. Blumenthal D. Academic-industrial relationships in the life sciences. Participation of life-science faculty in research relationships with industry.

NHS Education for Scotland. Association of American Medical Colleges. National Institute for Health Research. How do we encourage clinician scientists in Singapore?

Ann Acad Med Singapore. McCurry J. Japan unveils 5-year plan to boost clinical research. The patient-oriented clinician-researcher: advantages and challenges of being a double agent.