The Drug Effectiveness Review Project (DERP) is a self-governed collaboration of state Medicaid and public pharmacy programs that commission high-quality evidence-based research products to assist policymakers and other decision-makers grappling with difficult drug coverage decisions. Housed at the Center for Evidence-based Policy at Oregon Health & Science University in Portland, Oregon, DERP produces concise, comparative, evidence-based research products that evaluate the efficacy, effectiveness, and safety of drugs in many widely used drug classes.
Nationally recognized for its clinical objectivity and high-quality research, DERP focuses on specialty and other high-impact drugs – particularly those that have potential to change clinical practice. The program's goal is to ultimately help improve appropriate patient access, safety, and quality of care while helping government programs contain exploding costs for new pharmaceutical therapies. DERP uses a collaborative governing model to develop work plans that provide independent and objective research on drug effectiveness and safety to bring evidence to health policy decisions.
DERP reports include up-to-date clinical evidence on efficacy, adverse events, and safety information for the drugs reviewed. These reports and research products are not usage guidelines, nor should they be read as an endorsement of or recommendation for any particular drug, use or approach. Rather, DERP reports are used by policy makers to develop criteria for drug coverage, such as prior authorizations, clinical edits, drug utilization management policies, and provider or patient education materials. DERP research products include a comprehensive search of the global evidence, an objective appraisal of the quality of the studies found, and a thorough synthesis of high-quality evidence. Policymakers are able to use these reports and research products to make informed policy decisions that improve patient outcomes and contain costs.
Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care in England that publishes guidelines in four areas:
A medical guideline is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine. However, in contrast to previous approaches, which were often based on tradition or authority, modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine. They usually include summarized consensus statements on best practice in healthcare. A healthcare provider is obliged to know the medical guidelines of his or her profession, and has to decide whether to follow the recommendations of a guideline for an individual treatment.
A Patient Safety Organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection and analysis, reporting, education, funding, and advocacy. A PSO differs from a Federally designed Patient Safety Organization (PSO), which provides health care providers in the U.S. privilege and confidentiality protections for efforts to improve patient safety and the quality of patient care delivery
Dry needling, also known as trigger point dry needling and intramuscular stimulation, is a treatment technique used by various healthcare practitioners, including physical therapists, physicians, and chiropractors, among others. Acupuncturists usually maintain that dry needling is adapted from acupuncture, but others consider dry needling as a variation of trigger point injections. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. The American Physical Therapy Association defines dry needling as a technique used to treat dysfunction of skeletal muscle and connective tissue, minimize pain, and improve or regulate structural or functional damage.
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular [medical] condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs, biologics, vaccines and natural health products.
A glossary of terms used in clinical research.
The following outline is provided as an overview of and topical guide to clinical research:
Outcomes research is a branch of public health research which studies the end results of the structure and processes of the health care system on the health and well-being of patients and populations. According to one medical outcomes and guidelines source book - 1996, Outcomes research includes health services research that focuses on identifying variations in medical procedures and associated health outcomes. Though listed as a synonym for the National Library of Medicine MeSH term "Outcome Assessment ", outcomes research may refer to both health services research and healthcare outcomes assessment, which aims at Health technology assessment, decision making, and policy analysis through systematic evaluation of quality of care, access, and effectiveness.
Comparative effectiveness research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances. Engaging various stakeholders in this process, while difficult, makes research more applicable through providing information that improves patient decision making.
Patient participation is a trend that arose in answer to medical paternalism. Informed consent is a process where patients make decisions informed by the advice of medical professionals.
Consumer Reports Best Buy Drugs is a United States public, grant-funded project of Consumer Reports Health that provides consumers unbiased information about prescription medicines. The project educates consumers on safe, effective, and low-cost alternatives to their prescription drugs. It aims to improve access to needed medicines for Americans who struggle to pay for their medications. Best Buy Drugs compares prescription drugs for common health conditions based on effectiveness, safety, and price, to help people talk to their doctors about the most effective and affordable medicines.
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
There is a history of clinical research done on glycosaminoglycans, especially glucosamine and chondroitin, for the treatment of arthritis. Since glucosamine is a precursor for glycosaminoglycans, and glycosaminoglycans are major components of cartilage, ingesting glucosamine might nourish joints, and thereby alleviate arthritis symptoms.
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.
Janet Woodcock is an American physician and former Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
A pragmatic clinical trial (PCT), sometimes called a practical clinical trial (PCT), is a clinical trial that focuses on correlation between treatments and outcomes in real-world health system practice rather than focusing on proving causative explanations for outcomes, which requires extensive deconfounding with inclusion and exclusion criteria so strict that they risk rendering the trial results irrelevant to much of real-world practice.
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