How does a medical research project arise?

Medical Research Ethics and Rules:

Medical research is a highly regulated practice. At CROWDACURE we will never present a project that doesn’t comply with the current standards of medical practice and research.

The formal and informal regulations that now govern how it should be carried out have been tried and tested over many centuries. These regulations exist to make sure that all medical research is carried out to the highest ethical standard and always with the ultimate goal of helping patients.

Not everything is written, but the scientific community regulates itself: if a researcher doesn’t get his/her project reviewed by a peer-review committee, doesn’t follow a proper experimental approach or isn’t qualified to make that research, he/she will never be able to publish their research.

While the regulations may vary slightly between different countries, they are generally well aligned and the principles are considered universal.

Please do not hesitate to contact us if you have any questions or concerns about medical research regulations and/or ethical standards.

You can find more information on regulations of research in human subjects at:

http://en.wikipedia.org/wiki/Good_clinical_practice

http://www.who.int/ethics/research/en/

 

How is a medical research project born? What are the different steps?

1. The Idea

The Research Question: good ideas can come from anywhere.

For example, a doctor may notice that giving a patient a particular medicine for one disease also seems to help with another condition they happen to have. This is known as drug repurposing, and there are numerous examples in recent history of this happening which isn’t at all that surprising considering that many diseases have similar causes and can therefore, be treated in a similar.

A medical or scientific research idea involves a research question (example: “will Medication A have an effect on Symptom B or Disease B?”). A research question is necessary for various reasons. Mainly because it gives clarity and a clear objective to the research, but also because there needs to be a “testable” variable. For example, while we can hope and believe that a treatment works when it is tried on patients we cannot say for sure whether its’ effects are good or bad without strong evidence. All we can do is ask the question.

The Method: the proposed way to answer the research question.

The method is how a research project will be conducted; it outlines clear and easy-to-follow stages of the campaign.

Unfortunately, sometimes the outcomes of medical research projects prove unsuccessful notwithstanding a solid method. Luckily, “failed” research results can still be valuable to medics because it can allow that possibility to be eliminated from the equation. Thus, allowing research to move on and focus efforts on answering other research questions.

2. The Project Plan

The Protocol: once a research question and method have been defined, a detailed research plan is the next step.

The plan, which is in the project protocol, is divided into many parts; the research hypotheses, the research questions, the method, and the statistical plans that include implementation aspects and ethical considerations are all included.

Additionally, there are also practical aspects such as budgets, facilities, people and any other resources that might be needed encompassed in the protocol.

A great deal of care and consideration goes into drawing up the project plan, particularly when real patients are involved.

Peer-review: when the plan is ready it is presented to a group of leading experts known as the ‘peer review committee’ for validation. There are many trustworthy committees that are qualified to validate a project plan, though CROWDACURE uses the one that has the highest level of experience in the specific field.

Ethical Questions: the plan has to be reviewed and approved by the ethical committee, whose job is to ascertain the project plan is ethically sound.

Once the plan has been successfully approved, it cannot then be changed. If further changes need to be made the new plan must be reviewed again by both committees.

3. Funding

Now we get to the tricky part. Traditionally, there are three ways research is funded:

Each of these funding bodies look at different criteria when considering whether or not to give money to a particular research project. Governments’ priority is to address large and visible public health issues. The pharmaceutical industry is interested in the potential industrial applications of research as a business. Charities and individual philanthropists usually fund medical research in fields that they are dedicated to and/or have a personal interest in.

Despite these three important sources of funding, countless projects are not able to find a suitable source of money because they simply do not fit into any of the categories above. Even if they do, sometimes there just is not enough money.

Most research involving real people is expensive and requires significant funding. The projects on CROWDACURE are thought to be unlikely to be profitable, yet this is a misconception as the opposite can in fact be true.

Does this mean that these projects should not be funded?

Medical research in itself does not create financial value – only the industrial applications of that medical research have the potential to generate revenue. But it does have an important human value.

Since it is the crowd that will reap the ultimate rewards of medical research, we believe that it should be the crowd that decides which projects they want to see funded. At CROWDACURE we are giving you the opportunity to do just that. You have the power to bring an end to neglected medical research by directly supporting the medical research projects you believe in.

4. Research

Once the research team has managed to scrape together the funds they need, the interesting part starts—research!

Patients: in the case of a clinical trial, the research team starts by finding a number of suitable patients, also known at the patients recruitment stage. This can sometimes take a while as every potential patient needs to be thoroughly checked to make sure that they are fit to participate in the study and that they understand what they are agreeing to be a part of.

Now the research is actually happening! Once the group of patients has been gathered, the research can start. The process depends on the research question and the selected method. If the question is “does Treatment A work to cure Disease B?” then the patients are treated with the medicine or procedure being investigated. Observations are monitored over a pre-defined period of time.

It can sometimes take several years for the research team to have the necessary amount of observations or to be satisfied that the treatment has no long-term negative effects on the patients.

The necessary time is determined before the start of the project.

Partners for medical progress: as a member of CROWDACURE you will be a partner in medical research. Without you, this research would not happen for years to come, if it ever could have happened at all.

As such, during the campaign you will have a link to the research teams of any and all project you support.

You will be updated on the research advancements: three, four and five years are common time frames for a medical research project, and cohort studies can continue for decades.

Furthermore, most medical research projects go through a period known as the ‘black box’, i.e. when not a lot seems to be happening and results are few and far between. This means that updates on advancements are expected to happen not very often.

The research team will let you know beforehand what the major milestones are, for example when the patient recruitment is set to end and when the treatment phase begins.

Be patient—you can imagine how important a project must be if the research team are willing to invest so much time and energy in it! With medical research patience is needed, but rest assured that the final outcome will be big!

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