Clinical research

Clinical research


Clinical Medical Research trials are a great way take a proactive role in your healthcare and the wellness of your family. And that’s only one of the ways clinical trials benefit you, your family, and the world we live in. By participating in clinical trials, you help test investigational medications and treatments that may develop into a better treatment for people around the world.
Many research studies include paid compensation for time and travel and no-cost doctor visitation.
Besides helping to develop future medications and treatments, you gain access to new investigational treatments that aren’t widely available yet. In fact, many of the investigational drugs we research are already available on the market, but require further testing to maintain FDA approval.
Investigator-driven clinical trials (IDCT) are clinical trials
that are instigated by academic researchers and are
aimed at acquiring scientific knowledge and evidence
to improve patient care. Such studies deal with potential
diagnostic and therapeutic innovations that do not
attract or could even be against commercial interest.
Typical examples are proof of concept studies, studies
on orphan diseases, comparison of diagnostic or
therapeutic interventions, surgical therapies or novel
indications for registered drugs. IDCT thus have a much
broader scope and potential impact than industry-driven
clinical trials. IDCTs form a key part of patient-oriented
clinical research, and create the basis for continually
improving patient care.
Clinical research and especially IDCT are under strain
in Europe for a multiplicity of reasons. The European
Medical Research Councils (EMRC) of the ESF has therefore
undertaken this Forward Look exercise on IDCT to
analyse the problems and the needs, and recommend
solutions to the challenges identified.
This Forward Look represents what is probably the
most comprehensive examination of IDCT in Europe in
recent years. A thorough analysis of the problems faced
by academic investigators conducting IDCT was carried
out through a series of five workshops covering different
themes and attended by active and acknowledged
experts in the field. These workshops identified specific
issues that need to be addressed and recommended a
range of possible solutions.
The themes of the five strategic workshops were:
—categories and design of IDCT
—regulatory and legal issues, intellectual property rights
and data sharing
—management of IDCT
—education, training and careers, and authorship
—funding and models of partnership
A total of 88 recommendations emerged from the
workshops. These recommendations were subsequently
processed following the advice of the Forward Look
Management Committee, resulting in a list of 26 recommendations.
A consensus conference attended by around 90
delegates was held in September 2008. After debating
the recommendations, the individual participants were
invited to rank them in order of priority. These rankings
were pooled and a final ranking list was obtained

Clinical research is a branch of healthcare science that
determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Improved patient-oriented research in Europe will benefit
European citizens and the European medical industry
and facilitate the transfer of scientific discoveries from
the laboratory bench to the bedside. For Europe and for
the rest of the world this effort will be of great importance
for the quality of life of individuals and the wellbeing of
society as a whole.
To achieve this important objective, the European
Medical Research Councils (EMRC) at the ESF mandated
the undertaking of a Forward Look on ‘InvestigatorDriven
Clinical Trials’.
This consisted of a state-of-the-art analysis of the
current problems faced by academic investigators when
initiating clinical trials in Europe and the identification of
the investigators’ needs. This was achieved by organising
a consultation process involving high-level experts
already engaged in a similar strategic approach at a
national, pan-European or international level and focusing
on five main issues:
1. Categories and design of patient-oriented research
needed for promoting health research
2. Regulatory and legal issues, intellectual property rights
(IPR) and data sharing between stakeholders such as
academia, industry and patient groups
3. Management of investigator-driven clinical trials
4. Education, training, careers and authorship
5. Funding and models of partnership
The outcome of the consultation process, including
recommendations for how to solve the identified problems
and address the specific needs, was presented to
and further challenged by a broader high-level audience
participating in a consensus conference This group of
acknowledged experts was also requested to prioritise
the top five recommendations. This thorough and comprehensive
exercise is the basis for the present Forward
Look.
The Forward Look makes recommendations on how
to strengthen patient-oriented research with the aim
of improving clinical research in Europe and thereby
securing better health and welfare for the European
community. As science is global, strengthened medical
research in Europe will also benefit the rest of the
world.
As Chief Executive of ESF and Chair of EMRC it is
our privilege to express a warm thank you to all who
have been involved in this Forward Look process, and
to congratulate them for the impressive and important
result. We hope that Europe will listen and implement
the recommendations, which we believe are urgently
required given that clinical research in Europe is under
severe pressure. For example in Sweden, the leading
country in medical research as measured by production
The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.[1][2][3]
In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application[4] to the FDA for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition, clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly other institutional committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which federal regulations the research is subject to (e.g., (Department of Health and Human Services (DHHS) if federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants. These academic medical centers often have their internal Institutional Review Boards that oversee the ethical conduct of medical research.[5]

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.

In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.

Phases
Main article: Phases of clinical research
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Phase I includes 20 to 100 healthy volunteers or individuals with the disease/condition. This study typically lasts several months and its purpose is safety and dosage. Phase II includes larger number of individual participants ranging 100-300, and phase III includes Approximately 1000-3000 participants to collect more data about the drug.[6] 70% of drugs advance to the next phase.[7]

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
A panel of experts subsequently convened to develop
a strategy for the sustainable implementation of the recommendations,
paying particular attention to the top five
ranked recommendations. The advices for developing
an implementation plan are presented in this Forward
Look report. The four key stakeholder groups in charge
of their implementation are:
Group 1:
• Academic research
• Learned societies
• Universities
• Healthcare providers/hospitals
Group 2:
• National and EU funders
• National and EU regulators
• Ministries
• Ethics committees
Group 3:
• Patients
• Philanthropic organisations
• General public
Group 4:
• Private sector
In addition, a separate meeting was held to consider
particular problems faced by IDCT in countries of
Central and Eastern Europe (CEEC). It was concluded
that these countries face broadly similar problems to
those of Western Europe, but that the problems tend to
be more acute and extreme. A list of recommendations
to address the issues specific to CEEC is proposed.
We hope that this Forward Look will be the beginning
of interactive discussions between the stakeholders and
will generate strategic planning and implementation of
the recommendations so that better IDCT and clinical
research will improve patient care and health in Europe
and worldwide.