(Integrated Summaries of Safety and Efficacy)

Clinical trials (or clinical research trials) are a process by which new therapies and new drugs are studies to determine their safety and efficacy. The health organizations of each country, such as the FDA in the U.S. will use those data to decide if the product or treatment will be approved. Because each clinical trial is unique and have a specific design and different objectives, several reasons require the integration and summary of all the data. Hence while some clinical trials gather small safety studies in a small group of normal volunteers, other trials are efficacy studies that are carried in a large group of patients.

The first reason to generate ISE ISS is to allow a way to compare and discriminate small variations in the results of the study, therefore being able to create a review of the benefits and the risks profile of the investigational drug or treatment.

The second reason to generate ISS ISE is to reach solid statistical verdicts and conclusions. Ingrated data will allow to give the most accurate results in the statistical analysis of results, that no other hypothesis can achieve.

The third reason to generate and use ISE ISS is that the combination of data from various studies will give tools to find rare trends in some subgroups of patients, such as the elderly or people with specific diseases or people with different states of the targeted disease (i.e. mild vs moderate vs severe).

Finally, the use of ISE and ISS is required by health authorities when submitting a new drug application.

ISS is considered the most important document when filing a new drug application, and needs to cover data from phase I healthy volunteers to all data found in patients throughout the rest of the trials. ISS need to be extremely concise and must include the extent of the exposure of drug by the patient, several characteristics of all patients enrolled in the study, a listing all the deaths that occurred during the study, how many patients were drop-outs from the study, any potential serious adverse events, and adverse events and all lab results.

ISE usually summarize the data from phase II to IV, phase I studies usally being a safety control study.
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ISS ISE can be used to
Serves as a good detailed integrated description of the clinical section of the application
Give a comprehensive “overall picture” or sense of the clinical development program with regard to safety or efficacy; its strengths and weakness
Helps identify which studies require more in depth review.

ISE ISS can also be use to
Review the individual studies first and do his/her own independent integration of the results
later compare the reviewers integrated safety and efficacy findings with those of the applicant

Clinical trials or clinical research trials are a huge process by which pharmaceutical companies study the effects of a new drug or a new therapy in order to collect safety and efficacy data. Based on those data, the FDA or other government organizations in other countries will decide to approve the new drug /therapy or not. Because of its nature, clinical trials are extremely lengthy and costly, and the challenge to bring a new drug to the market is extremely big, even for the big and experienced pharmaceutical companies or biotech companies.

Recession have been defined by many economist, as a necessary part of our economy. Recessions allow us to redesign our economy, but especially to allow the “fittest” companies to survive, grow. Almost always immune to economic recessions and crisis, the healthcare industry is showing this time ¸signs of weakening and faces severe pressure. And with today’s recession going bad to worst, the worst is to come for the big pharma and biotech companies. Is the clinical trial industry globally ready to face it? What strategies will allow the clinical trial industry to survive the recession?

First, the industry will have (and have started) to reduce the workforce. Investors are more cautious with their investments and less likely to put money into risky drug development. Sponsors are cutting back on their budgets, less important studies will put aside, while the most important studies will see an abrupt cutback on how much money they receive. Therefore, the number of healthcare professionals needed for the industry will be reduced, leading to layoffs of healthcare professionals.

Second, many sponsors will move their work offshore, to other countries. Outsourcing to countries such as China, India, Eastern European countries is now often the key for many biotech and pharmaceutical companies to fight the effects of today’s economic recession. Hence, the value of work outsourced by countries such as the US to other countries can be up to over 40 per cent less.

Third, the clinical trial industry is getting computerized, to fight the effects of the economic turndown. The emergence of technologies has lead to an increase in the number of clinical trial software available. These clinical trial software allow for an increase efficiency in the management of clinical trial data and a reduced cost. Therefore, globally, the clinical trial industry will need to modernize the way of managing data in order to reduce the cost of processing and analyzing huge amounts of data.

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Finally, although economic recessions are difficult to live through, the clinical trials industry can survive the crisis if it wisely consider and adopt new working strategies to reduce the cost, but also to increase the efficiency of work and its workforce.

Joining a clinical trial

Clinical trials (also called clinical research trials or clinical research studies) can be a fast way to earn extra money. However, before enrolling in a clinical research trial, learn about what clinical trials are and carefully weigh the benefits and the risks of enrolling in a clinical trial. Here are the major factors (benefits and risks) you should take in consideration before becoming a clinical trial volunteer.

Potential benefits of clinical research trials

1.Experimental or treatment/drugs difficult to get

Treatments can be expensive and not affordable for many people

Joining a clinical trial can be beneficial to people suffering for an illness, especially serious illnesses. By participating in a clinical research trial, those people have access to medications or treatments that may otherwise not be available to the public. Also, because of their cost, many drugs or treatments may be out of question for several people, so joining a clinical trial may allow these people to have access to appropriate treatments.

2.Outstanding medical care

By participating in a clinical trial, you will have access to a full medical care

Participating in a clinical research trial also imply the access of to one of the best health care, and for free. When participating in a clinical trial, volunteers or patients undergo several health tests and are followed very closely by an experienced medical staff. For example, participants will usually get their blood tested, their urine tested, have their blood pressure checked on a regular basis and may undergo several other tests to determine the degree of illness or how much improvement there is in regards to the studied illness. Participating in a clinical trial may be an option in the U.S. or other countries where medical care is extremely expensive, therefore inaccessible.

3.Helping.
For many people, participating in clinical reearch trials also imply doing something good. It is through clinical trials that is it possible to develop new medications and treatments. Without those clinical trials and volunteers, new life-saving drugs or treatments or new treatments to improve the life of sick people would never find their way to the market. Hence, for many clinical trial volunteers, their participation is a great opportunity to give back and give other people a chance to live a better life.

4.Reimbursement

Paid clinical trials

Clinical resarch trials usually pay, and sometimes quite well. Participating in a clinical trial can therefore be beneficial if you need more money, because they can help you earn extra income.

Potential risks of clinical research trials

1.Side effects (or adverse events)

Side effects

Although the medical staff will inform every participant of all the possible adverse events (commonly called side effects) that you may experience during the trial. However, it is often difficult to predict what possible side effect a participant will experience, as they may experience none or all of the side effects previous participants have experienced. Moreover, because the treatment or medication is still under study, many side effects may not be known, and the participants may experienced other side effects, sometimes extremely unpleasant, even life-threatening. However, the medical staff and the company sponsoring the clinical research trial always closely monitor every subject and are available 24hrs-7days. In the case of a life-threatening side effect, the subject will be taken off the study, and all participants will be informed.

2.Invasive procedures
Some procedures and test may be extremely unpleasant. Before starting a trial, the clinical staff will inform the participant of all the procedure they will undergo. Therefore, before participating in a trial, you should talk to the clinical research staff and let them know if you have any concerns or worries about the procedures involved in the study.
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3.No results
Most clinical research trials have a placebo arm, which mean the participant may not be on the real treatment or medication. Also, in some cases, the new medication or treatment will be ineffective, and simply not work. In the case of a patient suffering from a serious disease however, a second medication, or treatment is added to the main treatment, to prevent the lack of efficacy of the new treatment or placebo.

Hence, before volunteering in a clinical trial, cautiously weigh those factors and determine whether a participating in clinical research trials is for you.

Are you late on rent? Are you finding difficult to decide whether filling up your car with gas to get to work or paying for groceries? In today’s economic crisis, it is common for many people to suddenly find themselves short on money. Available funds and traditional sources of credit are more difficult to find than ever. So here are 3 ways to raise cash in a few days.

Worried about money?

1. Taking in a “roommate”
You got into real estate when the economy was still going strong. But now that the world is drowning into the economic crisis, your chances to get that salary raise you were hoping to get to help you pay you mortgage are as possible as you winning the lottery. You have that extra room you use as an office space (that you used once… when you put together the office table) or that extra room you are now using as storage space. Sharing living expenses can be a good way to help you earn a little bit more income every month and will add more cash in your pocket. However, make sure that when you ask someone to move into your spare room, you draw up a lease agreement, even if the prospective tenant or boarder is someone you know.
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2. Renting your luxury accessories
While the economy was blooming and money was “growing on trees”, you decided to indulge yourself and got yourself a few high end accessories. The “Louis Vutton”, “Gucci” and “Prada” are sitting at the back of your closet. However, with today’s economic recession, you find that the occasions to take them out of their protective bag is happening less and less often. Although the economic slowdown is touching everyone, not everybody is willing to get over their taste for luxury. Some creative people have found a new way to making money: renting out luxury accessories. Instead of committing themselves to buying one expensive item that they will need to keep for the rest of their life, and digging deep into their budget, some people now prefer to rent luxury accessories. Hence, those people will rent an otherwise too expensive bag or dress for a special occasion such as a wedding, a prom or or business cocktail

3. Becoming a clinical trial volunteer
You probably heard about them on TV, on the radio or read about them in the paper. However, when money was “growing on trees”, they never caught you attention. As a matter of facts, clinical research trials were once mostly popular among the student population. In today’s economic turndown, clinical research trials are now more and more popular as a way to make quick and easy money for everybody. Before you enroll in a clinical research trial, the staff conducting the studies will determine if you are suitable for the study (inclusion and exclusion criteria). After you enrollment, you will undergo several procedures and may test a new medication or therapy. How much they pay will depend on the clinical trial you decide to enroll in, and on the drug development phase. Although they may pay well, you have to remember that there may be side effects from the new medication or therapy. However, the clinical trial staff will let you know about all the possible side effects of the new drugs, and your health is always their priority. Finally, as a subject, you have the right to leave the study at any time.

This list is not exhaustive, and there are many other ways to generate extra income. Keep your eyes and ears open and look for opportunities.

Make money fast

The birth of the new technologies marks the peak of drug discovery. In our modern society, with rapidly growing technology, we are now able to push research to a level never seen in the past centuries. Hence, biotechnology has given us more tools to understand the insights of the human body and its mechanisms. Everyday, new discoveries bring us closer to a longer and healthier life by giving us the aid to fight diseases, but also to prevent them.

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Human Fetal Lung Fibroblast Cells (MRC-5 Line). These cells were taken using a confocal microscopy . Confocal microscopy allow us to look at specific part of the cells at a high resolution.

In the old days, discovery of drugs often happened by fluke. A good example is the extraordinary discovery of the penicillin by Alexandre Fleming in 1928. A spore from a rare plant (Penicillium) from a mycology lab one floor below drifted in his lab, on a bacterial culture dish, leading to one of the greatest drug discoveries. Nonetheless, if we always had to wait for that type of fortune to happen, discoveries would be extremely rare. Nowadays, new successful drug discoveries depend less on luck and more on the combination of modern benchwork and great science. This is made possible by our more in-depth understanding of the human body and biology combined with more sophisticated tools. In spite of the skyrocketing number of drug discoveries, steps between drug discoveries and their marketing on our drugstore shelves are numerous and often laborious.

Clinical Trial Definition

In search of a new medicine

Clinical trials  (also known as clinical research trials or clinical research studies) study the impact of a drug that is intended to be use in humans on human subjects. Clinical research trials, are part of an important process allowing the collection of data about safety and efficacy before new drugs (including new devices) can be marketed. They are also intended to detect or verify the clinical, pharmacological or pharmacodynamic effect of the drug, identify any adverse event relative to the drug and allow to research other important elements in the comprehension of the drug, such as its distribution and excretion. Clinical research trials can only take place after adequate information have been collected on the product: thorough and promising non-clinical research findings have had to be made first. Consequently, Health Authorities has to approve of them, in the granted country, before any studies on human subjects can start to take place.

Clinical research trials are strictly regulated in every country and follow what are called Good Clinical Practices (GCP), provided by the International Conference on Harmonisation (ICH). GCPs are intended to define a standard in clinical trials across the world and are especially important in the fact that their guidelines include the protection of human rights as a subject in clinical trial, therefore allowing any volunteer that passes the inclusion criteria to join a trial and more importantly, to remove their consent at any given time. They also ensure proper habits and safe practices among the professionals of the industry. Hence, clinical research trials are subjected to international regulations, to regulations specific to each country in which the investigation is conducted, but can also be subjected to regulations specific to a state/province and even to the institution where the study is taking place (ex: hospital).

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

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Clinical research trials follow very strict protocols, designed by experts in the domain, and all study investigators must adhere and comply to the given protocol. Any deviations needs to be recorded and authorized by the sponsors.

There are 4 possible phases in clinical trials, which indicate the stage of the product development and each phase can include very distinct elements. Depending on the type of products as well as the stage of the product development, healthy volunteers(controls) or patients can be enrolled. The number of enrolled patients can be increased if and as more positive safety data are collected. The overall number of enrolled volunteers and patients varies for each clinical trial which size also also varies. A trial can be as small as one center in one country or as large as a multicentres trial in multiple countries.

The number of steps between drug discovery and its approval by Health authority for its marketing are fastidious and lengthy. However each step is essential and ensure both efficacy and safety of any new drug. And it is through these trials that investigational drugs, devices and diagnostics may show their benefits.

References:
(1) U.S. Food and Drug Administration (FDA)
(2) Health Canada
(3) Mickey C. Smith (1996), Pharmaceutical Marketing in the 21st century, The Harworth Press

Clinical trials (or clinical research trials) look at the response of human to a new drug or therapy. However, because of the vulnerability of some groups of people, if targeting on those groups, some studies have to be redesigned to consider the special needs of those people. Hence, those groups may need special considerations regarding the risks and benefits of the new drug/therapy, and the dosage or scheduling may need to be readjusted compared to the general adult use.

(a) Inclusion of Pregnant Women in Clinical Trials
Because of the possiblity of the investigational compound being passed to the foetus, clinical research trials involving pregnant women need special attention. Generally, pregnant women are excluded from clinical trials, unless the medicinal product is intended for use during pregnancy. Importantly, if a patient/volunteer become pregnant during the treatment phase of the clinical trial study (after the first dose of study medication/therapy was administered), the patient or volunteer is usually discontinued from the study, if this can be done in a safe way. The pregnancy of any women who become pregnant during a clinical trial study have to be followed up, even after the birth of the child. Indeed, the evaluation of the pregnancy, but also of the foetus and child is very important, to make sure that the compound, not only has no side effects on the mother, but also on the pregnancy, the foetus and the born child.

If a woman becomes pregnant during a clinical trial, she will normally be taken off the study and closely followed throughout her pregnancy.

(b) Inclusion of Nursing or lactating women in Clinical trials
Several medicinal products can be excreted in the milk of a lactating woman. This is why it is important to examine excretion of the drugs or its products in the milk of lactating women enrolled in a clinical research trial. This assures that there is no excretion or a safe level of excretion of the investigational drug in the milk of the lactating mother. If applicable, babies from lactating and nursing women enrolled in clinical research trials are closely monitored for the effects of the therapeutic drug.

Drugs or their metabolites can be excreted in the milk of the mother.

(c) Inclusion of Children in Clinical Trials
Children are much smaller and vulnerable than adults. This is why clinical research trials carried on children have to be redesigned and have to consider the child`s size and physiology. The decision to include children in a clinical trial will depend highly of what is known about the investigational drug and the possibility of extrapoling data and results from adults and children of other age groups. Also, some drug may be used in children from the early stages of drug development.
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Hence, although children, pregnant women and nursing women are usually excluded from clinical trials, if enough data is gathered from other clinical research trials, new studies can be redesigned to suit those groups challenges. However, adults that are not at risk of becoming pregnant are usually a preferred group for primary safety data.

References:

(1) ICH E6
(2) ICH M3
(3) Health Canada
(4) FDA

Where should you look?

“ Clinical Trials (or Clinical Research Trials) study human response to a new drug or therapy. A Clinical Trial Volunteer is a person who volunteers in testing a new drug or therapy. The information is collected at the Clinical Research Center, and will determine whether the investigational compound or therapy will be approved for release on the market.” So you’ve done your preps. You looked up the definition of clinical trials, gathered information and facts on the different phases  (Phase I-IV), different studies (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use), risks and side effects (in regards to different type of phases or targeted disease) and have decided why, you personally, would like to become a clinical trial volunteer.

The next step is now to look for a clinical research center where you would like to join as clinical trial volunteer. If you have been in clinical research trials in the past, you may want to reconnect with the clinical research center: give them a call, to find out what is available for you. However, if for any reasons, you needed to look for a new center, or if you have never taken part of clinical trial, here are the five top places a clinical trial volunteer might want to browse to find a nearby clinical research center.

1.Hospital
A lot of physicians and specialists affiliated with a hospital are also involved in clinical research trials. Therefore, you may want to give the hospital a call and tell them that you would like to become a clinical trial volunteer to find out about any ongoing studies. You can even decide to be more specific and chose a particular department (respiratory, oncology, arthritis, etc.) and directly call the department or visit their website, as many of them will list the type of clinical trials available in their departments. Finally, at your next appointment at the hospital/clinic, make sure you have a look at the board near the font desk, you may find out that the clinic is also a clinical research center and many of the doctors will post their ongoing trials and needs for clinical trial volunteer there.

2.University
Similarly to hospitals, a lot of physicians and specialists affiliated to a university are also involved in clinical research trials. However, to find out about them, it may be easier to look into the university website than to call the university. Also, because a lot of  college students enroll in clinical trials, you may also be able to find many posters about ongoing clinical research studies on the university campus, such as in the cafeteria boards or in general poster boards on the university campus. So on your next lunch break, have a look on the school posting boards and find out a nearby clinical research center.

3.Local Journal
Next time you go for a walk, pick up the free newspaper. To find enough clinical trial volunteers to enroll in their studies, many clinical research centers advertise in local newspapers. Some newspapers have a dedicated section for clinical trial volunteers in the last few pages (ads section) of the newspaper. However, in some papers, you will find clinical research trials ads throughout the whole journal, so while you are reading the latest news about Hollywood, also carefully browse the surrounding ads.

4.Telephone directories
Although more associated to finding a nearby florist or plumber, the Yellow Pages book also contains a useful directory of independent clinical research centers in your region. Those centers are usually not affiliated with any hospitals or universities. So pick up your dusty and heavy Yellow Pages book (or any other telephone directory) or use their online website and search for the trial centers in your area.

5.Internet
The new way of spreading the news and information is through the use of the internet. Although internet allows a quick search, the information gathered may be less specific. For example, although the number of listing and directories for clinical trial volunteers are numerous, it may be difficult to find a clinical research center in your area. As you become more familiar with the terms and with the right sets of keywords, you may find just what you need. So hop on your computer and start “googling” your way through clinical trials.

Finally, although it may give you a good start, the list suggested above is not exhaustive and you may need to look further to find a clinical research center that carries a study that interests you as a clinical trial volunteer. Keep your ears and your eyes open, you will realize that information is more common than you thought: people you may know, radio ads, your family doctor, community center boards, etc.

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The first therapy study on a human subject using human embryonic stem cells was approved by the American government, making the U.S. a pioneer in this field, and opening new doors to research targeting injuries and incurable diseases.

The American agency’s spokeswoman Susan Cruzan has confirmed that: “The food and drug administration (FDA) has authorized a phase I clinical trial from Geron Corporation (a California-based biotech company that focuses on therapeutic products for cancer, cell aging, injury or degenerative diseases). This phase I trial will treat patients with severe spinal cord injuries”. The biotech company had submitted a 21 000 pages report to support their request, showing that the investigative therapy showed a high efficiency on rats and other rodents.

This phase I clinical trial will be conducted on a small group of patients to assess human response to this new therapy. “This novel therapy is a sign of a new era in medical discoveries and therapies” says the Geron Corporation C.E.O., Thomas Okarma. And he adds “This new treatment represents the first cell therapy that could be made and developed in a similar way to that of a biological treatments or antibodies. The therapy uses the normal biological development of the human body, and we anticipate to permanently be able to cure chronic diseases and trauma.”

Embryonic stem cells are the only stem cells that have the ability to grow and develop in any other type of cells. Therefore, the goal of the GRNOPC1 study is to inject human embryonic stem cells on paralyzed volunteers, in the hope that those cells will be able to generate new neural cells and replace the damaged ones, potentially allowing paralyzed people to regain sensitivity and eventually the ability to move.

Because of their distinctive pluripotent feature, embryonic stem cells have a thorough potential to cure diseases such as cancer or Alzheimer. However, the biggest challenge of this study is to achieve differentiation by the embryonic stem cells into the targeted type of cells , without the risks of those cells changing into intrusive cells such as tumors.

The use of human embryonic stem cells is highly controversial because the stem cells are removed from an embryo at its first stage of development (known as blastocytes), leading to its premature destruction. According to Geron Corporation, the stem cells used in the preclinical studies were produced before the Bush administration banned the use of government grants to support research on new cell lines. The cells used for these researches come from unused embryos in specialized clinics where couples use in vitro insemination, and that would end up being destroyed and discarded.

The Bush administration banned the use of human embryonic stem cells for ethical and religious reasons, as well as for the respect of a human life. Nevertheless, Geron research as well as the FDA decision to approve embryonic stem cell research on human are legal and valid in respect to the Bush administration legislation to stem cell research. The new FDA approval could speed up a change in the legislation and regulation of stem cell research, promised by the Obama administration. Public interest in stem cells research reached its popularity when Superman actor, Christopher Reeve became paralyzed in a car accident in 1995.

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For more information, visit http://www.clinical-trials-info.com/

Four factors to consider

Clinical trials (or clinical research trials) are conducted with healthy volunteers or patients to evaluate a new medical treatment, drug, or device. The goal of clinical research trials is to find new and better methods of treating different diseases and disorders. Through clinical research trials, the efficacy of a new drug or treatment on humans is determined.

Another important purpose of clinical trials is to find possible adverse events (also known as side effects). Hence, new treatments or new drugs may cause adverse events that need to be detected before they can be approved by the authorities to be released on the market.

Before they are enrolled in a clinical trial, volunteers and patients are informed of any known or possible potential risks in regards to the new therapy they are considering testing. Ultimately, it is always the patient or the volunteer decision to join a study or not, based on their degree of comfort with any potential side effects and their confidence in the new therapy. Participants need to carefully assess the benefits versus the risks of enrolling in a clinical trial. Each patient or volunteer should think out prudently the possible side effects that may occur when testing a new treatment or drug. To help assess those risks, there are a few elements subjects should consider:

First, it is believe, and often with fair reasons, that the risks or the number of side effects that may occur in new therapies are elevated. However, it is important to remember that many of the drugs or treatment already approved and found on the market can also have some side effects . Hence, although some of the new medications will have worst secondary effects than the medicines already approved, many new therapies may have less effects or similar effects to the existing ones.

Second, different subjects may experience different level of tolerance to a new medication. Hence side effects may be different between the different subjects. Pre-clinical research and data often give scientists and physicians imprecise ideas on how people may react to a new drug or treatment. This imprecision adds to the fact that every subject or volunteer is different. Therefore it can be very challenging for the physicians and scientists to determine what exact side effects someone will be experience. In order to help determine and limit as much as possible the potential side effects of a new drug, subjects have to release their medical history.

Third, the type of risks in clinical research trials may also vary depending on the type of disease or disorder the new therapy targets. In this case, the level or risks is rigorously assessed by qualified physicians and scientists from the sporing pharmaceutical company, by authorities and by ethics committees. Those ethics committee consists of qualified physicians and scientists, volunteer and patient delegates, jurists and lawyers and other non-specialists whose duty is to carry out advisory and enforcement responsibilities in regards to clinical trials in an impartial manner.

Fourth, if, at all time, there is any occurrence of a serious adverse event (a side effect that can put one’s life in danger) related to the new drug or treatment, the company sponsoring the new therapy and the principal investigator on site are required to notify the other participants right away. In some cases, the study can even be put on hold or discontinued until more information is available.

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In summary, participants have the rights to know what type of side effects they may encounter during a specific clinical trial. Companies sponsoring clinical research trials, as well as the investigators and their staff are required to alert other volunteers and patients in case of a finding of a serious adverse event related to the investigational drug in one or many participants. And at any given time , volunteers and patients have the right to withdraw their consent from the study.

For more information, visit http://www.clinical-trials-info.com/.

3 factors to consider before participating

Are you thinking of joining a clinical trial? Before you decide to enroll in one, there are several points to consider.

First,
What are your personal time constraints? If you are restricted to periods of time that you can utilize to take part of a clinical trial, then naturally you will have to stick with them and, therefore, not all studies will suit your schedule. If you have a full-time job, it might be difficult to take time off to join some specific type of clinical research trials. If you chose a center far away from your workplace or your home, you have to take in consideration traveling time. Remember, some clinical research trials are time consuming and might require you to stay at the trial center for hours, even for a full day and night. Be part of a clinical trial is more than joining, it also mean commitment. In order to have accurate results, pharmaceutical companies need trial centers to stick to the protocol. If you show low commitment to the trials, results will be inaccurate and chances are that you might be less likely chosen to be part of further studies. So, before you enroll in a clinical trial, make sure that you work schedule will allow you to take the time off for all the visits.

Second,
What are the most important aspects for you in regards to clinical research trials? Do you want to reach out to specific diseases? Do you have asthma or someone close to you suffer from arthritis and you would like to help out in these fields? Then you will need to research the various type of studies and trial centers in your area to determine which ones carry the type of study you are interested in. Perhaps you do not mind what field of disease or illness you are helping out. In this case, more options are open to you. Call your closer trial center and inquire what studies are there.

Third,
How important is compensation to you? Is money an issue to you? Is your participation in clinical research trials a way to give a little boost to your tight budget at the end of the month, or is you participation a “service to the community”? These considerations might give you an idea of your study choices, and even restrict you in regard to which clinical trials you might consider joining. The drawback is that, unfortunately, money often comes hand in hand with risks and side effects. Phase I trials compensate more than Phase IV. However, risks and side effects of Phase IV investigational drugs are well known, and often minimal compared to those of Phase I of clinical research trials. Similarly, time commitment may indicate money compensation. If you have to stay a full day at the center, chances are that you will get more compensated than for a 2 hours visit at the trial center. Hence, before joining a clinical trial, you might need to take take a look into compensation, time commitment and side effects, and decide whether payment will outweigh the risks of side effects as well as long visits at the trial center that may be related to some clinical research studies.

This gives you three major points to think about when determining what type of clinical  research trials you should participate in. Some center focuses more on distinct type of trials. These centers may concentrate on specific diseases, such as diabetes or asthma, and may carry one phase or many phases of clinical trials. Some trials may require a lot more dedication than others. And while some studies do compensate a lot, other do not offer any compensation.

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Finally it is important to remember that no matter what factors will make you pick a trial over another one, all clinical research trials are rigorously regulated by health authorities, and in all clinical trials, emphasis is put on subjects and patients safety.