Tag: clinical trials

05 Jul 2017

Personalised (precision) medicine: what is it, and how does it work?

John received chemotherapy for colon cancer. The chemotherapy drug that he used, however, was not effective for him. He also experienced severe nausea and diarrhoea when using this chemotherapy.

He speaks to another patient treated at the same hospital, who has the same type of colon cancer and who received the same chemotherapy. For this patient, the chemotherapy was very effective and the patient only experienced mild nausea. What causes these differences between patients and what approaches are needed to overcome them?

Patients have different responses to different treatments, as well as different adverse reactions[1]. These differences could be caused by genetic or other factors. The solution here lies in personalised, or precision, medicine.

What is personalised medicine?

Personalised medicine is the concept of adapting patient treatment (drug and dosage) to a specific patient, based on that patient’s specific characteristics, such as genomic information and environment[1].

The aim of personalised medicine is to provide a patient with the correct treatment regimen that will potentially result in better treatment of a disease, as all patients do not have the same characteristics and do not respond the same to the same treatment.

What is required for personalised medicine to work?

Personalised medicine typically consists of two parts: firstly, using diagnostic medical devices to identify specific characteristics of a patient. Diagnostic devices or tests could include, amongst others, genetic tests, or imaging equipment. Secondly, therapeutic products (drugs, devices or other treatments) are provided based on the results of the diagnostic test[1].

This implies that there could be a synergy or collaboration between device and pharmaceutical companies in providing personalised medicine to a patient.

For personalised medicine to be successful, data on past patients should be available. This can be in the form of patient registries or clinical trials. This data should include the various characteristics of the patients (for instance, biomarkers, genetic information, age, gender, family history, etc.) and disease (especially if the disease can present in different ways). This data should also provide information on the outcomes for patients using specific drugs.

Predictive and prescriptive modelling can be used to analyse this data and provide insights into the relationships between patient characteristics (biomarkers, genetic information, etc.) and the outcome (cure or survival using a specific drug). Predictive and prescriptive modelling can also be used to determine if patient characteristics have a significant impact on the outcome, whereas this can become a focus point or objective for further research. This is done to further improve knowledge and treatment habits for a given patient.

As mentioned in a previous blog post, “Predictive and prescriptive modelling in health care”, TCD Outcomes Research can assist you in your prescriptive and predictive modelling requirements. We can also assist in positioning your product, using this information, for the correct market segment. This will not only assist the pharmaceutical or medical device company, but also the patient, for whom funding for the correct treatment would more likely be available from the medical aid. A patient would also know that treatment with a specific drug is catered to their needs and that the patient receives the best treatment based on his/her medical records.

 

References

  1. S. Food and Drug Administration. Paving the Way for Personalized Medicine – FDA’s Role in a New Era of Medical Product Development. October 2013. Available from: https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf. Accessed on: 15 March 2017.
02 May 2017

TCD joins EOH as the group grows with strategic changes taking effect in May 2017

We are delighted to share the following significant changes and positive developments which took place recently within the TCD Group.

New Ownership

EOH, a JSE-listed South African based Knowledge Management group, have been in negotiation with the TCD Group since the last quarter of 2015, sharing the strategic objective to expand in the field of healthcare. EOH consists of a diverse portfolio of specialised industries in 21 countries across four continents.

The groups came to agreement in October 2016 and the transaction was completed in February 2017. EOH Holdings is now the 100% shareholder of the TCD Group of companies. We are excited by this positive development which opens many new horizons through the global profile of our new proudly South African owners.

The EOH philosophy involves sustaining successful acquisitions by building upon the inherent culture. The TCD Group will remain easily recognisable, building on our rich legacy, striving as always for continuous improvement.

Expansion of the TCD Group

The rapid evolution of the TCD Group expanded the original Triclinium into a full-service CRO (Contract Research Organisation), with a growing range of services and geographical footprint. Triclinium’s sister companies, within the TCD Group now consists of:

  • TCD Outcomes Research: The TCD Group developed a Health Economics and Outcomes Research (HEOR) organisation, through an acquisition of HeXor (a late phase development and pharmacoeconomics company), combined with the Late Phase Clinical Development expertise of TCD.
  • TCD e-Clinical Solutions: The TCD Group created an e-Clinical Solutions division which includes Software as a Service solution. TCD e-Clinical Solutions is focused around improving the outcome of clinical trials from a quality and efficiency perspective. Services include Electronic Data Capture (EDC), Electronic Medical Records (EMR), Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcome Assessments (eCOA) and Mobile Health (mHealth), etc.
  • TCD Global Data Services: The TCD Group established and consolidated its Data Management and Biostatistics division under the TCD GDS brand, which is spearheaded out of South Africa and Bangalore, India.
  • TCD-MENA: The TCD Group established a full-service CRO based in Cairo, Egypt through a Joint Venture to focus on the Middle East and North Africa region.
  • PharmaLTX: The TCD Group established a software development company which specialises in software solutions in the wider health care sector such as partnering with Ministries of Health, Regulatory agencies, Institutional Review Boards, Universities, Clinical Research Centres, etc.

 

New TCD Group Chairman

The mandate to meld the member companies into a synergistic group has been entrusted to Dr Tienie Stander, founder of HeXor Pty Ltd., current Managing Director of TCD Outcomes Research, and now also the inaugural Chairman of the TCD Group.

Change in Managing Director of Triclinium Clinical Development

To those who know the company well, the most visible change is that after 17 years at the helm, founder Victor Strugo will relinquish the position of Managing Director to Abraham van Wyk, effective 1st May, 2017. Abraham has been increasingly involved in TCD executive functions since 2014 and his promotion is fully endorsed by TCD’s Board of Directors.

Victor will nevertheless remain active and visible in the new role of TCD Group Strategic Adviser, facilitating a smooth management transition, supporting key projects and developing new horizons for the company that he created in February 2000.

Our electronic media will be updated accordingly over time. We look forward to maintaining and strengthening our association with your organisation through this transition and to offer an ever-improving and broadening range of services in the years ahead.

For queries or more information, contact us at corporate.communications@tcd-global.com

31 Jan 2017

TCD MENA officially registered as CRO in Egypt

We are proud to announce that TCD MENA is now officially registered as a CRO in Egypt. Complementing TCD SA’s long-standing outreach into sub-Saharan and West Africa, TCD MENA was recently established in Heliopolis, Cairo to extend the provision of TCD’s clinical development services to clients looking to conduct research in the Middle East and North Africa (MENA) region.

The TCD MENA team has extensive clinical research experience in managing global clinical trials with sites in Egypt and the MENA region, as well as managing bioequivalence studies accepted by WHO, FDA and EU. Their expertise covers various therapeutic areas, including Oncology, Hepatology, Internal Medicine, Gynaecology and chronic diseases with strong relationships with KOLs across Egypt and the MENA region. Services include Regulatory Affairs, Clinical Operations, Project Management, Pharmacovigilance, Data Management, Biostatistics and Medical Writing.

We at TCD South Africa are excited about this long-standing partnership with TCD MENA, and in walking this road for the benefit of humanity.