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To contact clinical research organisation Ixia Clinical call 01992 217 172 or visit their web site at www.ixiaclinical.com.

How a clinical research organisation can help act as a bridge between the pharmaceutical companies and consultants and their patients

Clinical trials are used for a number of reasons from illness prevention through to curing disease. The clinical research organisation plays a pivotal role in this process because they are responsible for planning, setting up, collecting data and delivering results, working in partnership with consultants and other organisations such as pharmaceutical companies. However hospital consultants and pharmaceutical companies often have very different views as to how the trial should be delivered and managed to achieve the best results because they will be working towards different outcomes. Therefore, the clinical research organisation has to act as a go between to facilitate communications and ensure that the trial not only meets the requirements of all parties but it delivers valuable results.

Clinical trials do not necessarily concern assessing medicines they can be used for a number of reasons including those which help individuals to change their behaviour or lifestyle. Educational programmes can also be tested through a clinical trial because they can be used to improve understanding of specific medical conditions so they can be managed more effectively.

The process of a clinical trial is important for many reasons. They are one of the most effective ways to both treat and prevent illness and other health issues. Patients and health professionals need the information from these trials so too do pharmaceutical companies to develop safe medicines and create treatments that are beneficial. Without a trial patients could be given treatments which have little to no benefit, healthcare teams will waste resources and pharmaceutical companies will spend money developing drugs which do not work or could pose a risk to patients.

Some forms of clinical trials are developed to evaluate treatments in the early stages of development. Researchers and regulatory bodies will carefully scrutinise the results from clinical trials to determine whether the proposed treatment or medication is safe and in the best interests of the patient before they issue the relevant approval.

The role of the clinical trial

Clinical trials have been used for many years for the following reasons;

  • As an attempt to figure out if illnesses can be prevented by using new vaccines
  • To determine whether illnesses can be detected or diagnosed earlier through scans or blood tests
  • If the treatment for illnesses such as cancer can be improved or new treatments can be introduced
  • To improve the quality of care and psychological support to both patients and their carers
  • To explore ways in which people manage their symptoms and find new ways to improve their quality of life

The clinical trial process

Once a clinical research organisation makes the decision to complete a clinical trial, they will have to progress through four stages. Any proposed treatment will be thoroughly tested progressing through a number of stages in the clinical trial process to conclude whether they are safe and whether they will work. New treatments must pass through each stage of the clinical trial process to receive the relevant approval.

The four phases of a clinical trial are conducted in accordance with stringent guidelines often referred to as the clinical trial protocol. This ensures that the trial is carried out correctly, safely and the right elements are measured properly. Clinical trials will have to pass strict verification procedures which are carried out by research ethics committees and various regulatory bodies as well as company research and development departments. This is even before any clinical trial can begin.

Phase 1 Studies

A clinical trial in this phase will involve tests carried out for new drugs for the first time but with a very small sample of participants. The trial will determine whether the drug is safe to use, any side effects and the quantities of the drug that can be administered safely and the frequency of the dosage.

A Phase 1 trial may be offered to patients with advanced conditions such as cancer and who have exhausted all other options for treatment. These trials will also involve testing experimental drugs which identify genetic faults and as a participant you may be asked whether you can be tested for these genetic faults. If the cancer that you have falls into one of the faulty gene categories, you will be invited to participate in a therapy trial as part of the experiment, either after or before you have received routine or standard therapies.

Phase 2 Studies

This study is a step up from Phase 1. Often larger, the purpose of the Phase 2 study is to;

  • Explore how medicine functions when administered to treat specific types of cancer
  • Understand whether there are any side effects of the drug and how they can be managed
  • Determine the most suitable dosage

During a Phase 2 study, there may be lots of comparisons made with existing treatments and this is where the clinical research organisation will need to collaborate both with hospital consultants and pharmaceutical companies.

Phase 3 Studies

Phase 3 is more complex again and it aims to carry out comparisons with new treatments which have passed through trials at both Phase 1 and Phase 2 with current treatments which have proved to be the most beneficial. It is not uncommon for a phase 3 trial to last a year or more and it will be carried out across multiple hospitals and even countries all at the same time. This type of study will also include a large sample of participants. The function of this trial will compare a number of things including;

  • The features and benefits of the new treatment in comparison with currently available treatments
  • The methods of administering the standard treatment
  • Alternative techniques of administering radiotherapy

Phase 4 Studies

Once the treatment has successfully passed the trials in Phases 1 to 3 and it has been proven successful it can be issued with a marketing licence. This phase will look specifically at safety issues along with side effects of the drug and its effectiveness when being used in daily practice. This is when conflict may arise between hospital consultants and pharmaceutical companies who are distributing the treatment. It is the role of the clinical research organisation to establish effective communication channels at this stage and bridge the gap so that the clinical trial is as successful as it can be and meets the requirements of both consultants and pharmaceutical companies while addressing patient needs.

The role of pharmaceutical companies

In recent years with advances in technology there has been a lot of talk about pharmaceutical innovation. Much of this innovation is linked to clinical trials and the clinical research organisations who are often accountable for developing and implementing them. Cost is always a factor when developing medicines in healthcare and the majority of these costs relate to clinical trials. A pharmaceutical company will be focused on keeping costs down whereas a hospital consultant will be more focused on the needs of the patient.

Trials are crucial for providing information about the safety and viability of potential treatments, how they could be used and which patient group(s) could benefit from them. Without this information, the breakthroughs in laboratories have little or no value. While a pharmaceutical company may be responsible for creating the medicines, they actually don't run a clinical trial themselves although they may be funded or sponsored by the pharmaceutical industry. The majority of clinical trials are conducted by independent bodies and professionals such as a clinical research organisation who will follow strict protocols and designs which are agreed on by all parties and ethical review panels.

The trial is usually led by a principal investigator who is usually a medical professional such as a doctor or senior consultant. They will lead the clinical research team which will include a range of multidisciplinary professionals including nurses, physicians and other healthcare specialists. Some larger Phase 3 trials will appoint an independent team of experts who will monitor data to identify any safety concerns.

Even though a pharmaceutical company may have made the breakthrough and may be funding the trial, they may have very little to do with the trial until they receive the data at the end. Some companies however like to be involved in the planning and implementation stage so they can have an input into the way in which the trial is developed and rolled out. Before conducting a large trial, smaller clinical trials may be carried out to assess the viability of a larger trial. However the value of a larger trial must be proven amongst a larger group of patients to meet the stringent standards to support an application to acquire approval from the relevant bodies.

Clinical trials are usually developed by doctors or other healthcare specialists but input can be obtained from a diverse range of people and increasingly patients are having a say in how trials are developed and managed. Clinical research organisations will work collaboratively with a number of individuals including pharmaceutical companies who may have made a breakthrough in their research which initiated the trial through to hospital consultants who are helping to design and manage the process. A clinical research organisation along with consultants will explore data from trials which have already been carried out to see what is currently known usually conducted through a systematic review. This will identify further questions which need to be addressed through further research or additional clinical trials.

Consultants, doctors, patients and researchers will work collaboratively with pharmaceutical companies, clinical research organisations and statisticians to design a suitable trial. The design will start to formulate a framework for the trial protocol. During this stage any conflicting priorities will be identified and resolved, usually by the clinical research organisation. Once the protocol is ready to be sent to the research ethics committee an independent selection of people which will include nurses, consultants, medical professionals, members of the public and occasionally legal professionals. The committee will then determine if;

  • The benefits of the new treatment are strong enough to outweigh the risks or side effects
  • Whether the information which has been put together for participants is satisfactory
  • The way in which people will participate in the trial is acceptable
  • If there will be sufficient compensation available if the trial goes wrong
  • Expenses should be provided to participants in the trial

The various people involved in planning the trial will be actively involved in its design. The design phase is split into two distinct sections; the first is the early stage and the second is the later stage.

Early stage trials will involve a small sample of participants or healthy individuals. These are particularly useful for educational programmes or psychological treatments where they can be used to refine the treatment before large scale testing begins. Where medicines are concerned an early stage trial will look specifically at side effects or safety issues. The later stage trial will involve large numbers of participants and are commonly randomised. A randomised trial is where participants are selected at random and assigned to a particular group. This group will then receive a specific treatment option and the group will include a variety of individuals including healthy, those who are older, younger and different sexes. The clinical trial process will help to reach important decisions about the way in which drugs are developed. This is important information for both the manufacturers or pharmaceutical companies and consultants who will be responsible for administering them.

Some clinical trials will be ongoing for a number of years so it can be many years before the results have been collected, collated and analysed. At the end of the trial the results will be available to everyone who participated. They will also be published so others can review the data to make informed decisions about their own healthcare and treatment. Researchers must publish the results irrespective of what the results are and outline how the results from the trial add value to existing knowledge on the issue.

The importance of a clinical trial should not be underestimated but consultants and pharmaceutical companies will have their own ideas about the design and implementation of the trial. A clinical research organisation can prove instrumental in ensuring that trials are conducted properly and the best interests of the patient are the focus of the research.