Evolution of Clinical Trial Agreement Review in Malaysia Through CRM

To regulate the conduct, relationships, responsibilities, and obligations of the parties involved in the clinical trial, the Clinical Trial Agreement (CTA) must be in place. The parties in a CTA are not usually limited to sponsors or contract research organizations (CROs), but also include institutions and principal investigators. The Malaysian Guideline for Good Clinical Practice, has defined the CTA as“A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.”(1) Read more

Where Are Clinical Trials Studies? – SIN CHEW DAILY (Translated)

Where Are Clinical Studies?
Check Online to Find Out 

“In October last year, Clinical Research Malaysia added a brand-new function to its official website http://www.clinicalresearch.my/. It is a prominent column in the lower right corner of the web page, with the tab “Find a Clinical Trial”. This new function brought good news to critically ill patients, especially those unable to afford expensive medical treatments. Patients and their families can find out which government or private hospitals provide new research or treatment options according to their medical conditions. 

Syed Hamzah -Business Development Executive, Clinical Research Malaysia (CRM)

In the website, the users can select between “Healthy Volunteer” or “Patient” and proceed to fill in their personal information to register themselves. Based on the information provided in the website, for “Healthy Volunteers”, they can choose Ampang Hospital in Selangor, three different hospitals in Penang and a hospital located in Kuching. For “Patients”, the diagnosis of illness and their location must be filled in order to search for the appropriate hospital. The participating hospitals in this clinical trial cover all parts in Malaysia, which include hospitals in major cities, as well as several large private hospitals. 

The clinical trials listed on the website covers several diseases, such as acute coronary syndrome (ACS), nonalcoholic steatohepatitis (NASH), IgA renal disease, lupus nephritis, anaemia, diabetic nephropathy, heart failure, glaucoma, breast cancer, lymphoma, thrombotic microangiopathy (TMA), thalassemia, leukemia, hepatitis C disease, prostate cancer, erosive esophagitis, depression, venous thromboembolism, stroke, etc. It covers almost all critical diseases that Malaysians have regardless of race, environment and gender. Unfortunately, as there is lack of publicity of this new function, not many people know about it. 

Not a “Guinea Pig”
Careful follow-up by the Medical Team 

However, not every applicant can participate in these clinical trials. Applicants must go through a series of review conducted by the Clinical Research Malaysia (CRM). Those who are interested can use this new feature in the website to submit their applications, as well as contact the major government hospitals for enquiries. 

In the past, many people lacked understanding of clinical trials. Their perceptions of clinical trials are that they are being experimented on like a guinea pig. There is a lack of understanding on newly developed drugs or treatment programs and assume it to be a high-risk procedure. In fact, patients who participated in clinical trials may not only obtain early results from the new 2 

drug treatment from the pharmaceutical company, but the results can also be followed up carefully through the Medical Team as well. Most importantly, these drugs have actually passed through layers of checks, and patients will not be treated as a “guinea pigs”. Therefore, clinical trials may be a source of hope for those with critical diseases.” 

By Syed Hamzah Business Development of CRM 

Syed Hamzah (middle) explained the new functions in the CRM website to the Sin Chew Daily Foundation Executive (right, No 3) and others

 

RM 480,000 drug costs reduced to RM1200
Recovery Rate of 97%
CRM sponsored a Hepatitis C combination drug study
By Khairul Faizi Khalid (Head of Business Development, Clinical Research Malaysia) 

Combination Usage of Generic Drugs
Malaysian-Thailand 500 people tested 

Hepatitis C virus can cause chronic liver inflammation, liver disease, and even liver cancer. Although there are drugs on the market for the treatment of hepatitis C, not many people can afford the treatment costs. A full 12-week course of treatment is around US$ 120,000 (around RM 480,000). 

Dr. Khairul Faizi Khalid – Head of Business Development, Clinical Research Malaysia (CRM)

In order to solve the challenges of increasing hepatitis C population and high medical expenses, Clinical Research Malaysia (CRM), Drugs for Neglected Diseases initiative (DNDi) (a non-profit research and development organization) and Pharco Pharmaceuticals (Pharco) (an Egyptian pharmaceutical company), have signed a collaboration agreement to manufacture and supply a new hepatitis C treatment regimen. In partnership with the Malaysian Ministry of Health (co-sponsored by CRM), DNDi is currently running clinical trials testing a potentially pan-genotypic treatment, combining the drug ravidasir, produced by the Egyptian drug manufacturer Pharco Pharmaceuticals, with the existing hepatitis C medicine sofosbuvir. 

According to DNDi, based on the interim results from the Phase II/III STORM-C-1 trial, 97% of patients enrolled in a full 12-week course of treatment were cured with the new combination of drugs. Most importantly is that this new treatment only cost US$300 (around RM1200), compared to US$120,000 for a full 12-week course treatment in Malaysia currently. 

This trial recruited 500 people in Malaysia and Thailand within 1 year. Out of 500 people, 400 are Malaysian. Hospitals involved in this project include Hospital Selayang, Hospital Ampang, Hospital Sungai Buloh, University of Malaya Medical Centre, Hospital Tengku Ampuan Afzan from Kuantan, and Hospital Sultanah Bahiyah from Alor Setar.

Exploring shortened treatment
Extend genotype 

Clinical trial on the new drugs has not yet ended. The next phase is to find the bioequivalent of the drug. The collection of blood samples for plasma level studies will be handled by Hospital Ampang. 

If the new drug is confirmed to have the same bioequivalent properties to the original drug in terms of safety, tolerability and efficacy, then patients will be able to receive high-quality drugs at an affordable price, which is undoubtedly good news. 

We have just concluded a meeting with DNDi and mentioned more possibilities for the efficacy of new drugs, such as shortening the course of treatment, and we found that some patients have no signs of viral infection at the eighth week of treatment. If the new drug duration can be shorten from its original 12-week course, then the patient can save on the treatment fee. 

The rate of new drug treatment depends on the patient’s own viral genotype, and most of the Malaysian patients belong to genotypes 1 and 6. Therefore, we will also explore the possibility of extending new drugs to genotypes 2 and 3 to achieve a broader coverage level. 

CRM Head of Business Development, Dr. Khairul Faizi Khalid (from left, no.3), Head of Finance and Information Technology, Mr Yau Yit Huan (from left, no.2) and Business Development Executive, Syed Hamzah (from right, no 3) visited Sin Chew Daily and was welcomed by Chief Editor of Sin Chew Daily (right, no. 4), Chief Editor of “Easily Page” and reporters

The Government issued a compulsory license
Resolve Hepatitis C Patients’ Problems 

We are proud to inform that Hepatitis C patients in Malaysia are the first recipient of this new drug treatment. Usually, new drugs are introduced to Malaysia after approval by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). By then, it may be too late for patients. 

In addition to developing new drugs, the government is also actively taking action to overcome high drug costs and this is done by issuing compulsory licensing. Our country’s hepatitis C population is currently as high as 500,000 people. If the government does not intervene, it is estimated that by year 2030, the number of patients will increase to 3 million. Therefore, the government issued a compulsory licensing for the sofosbuvir patent in September 2017, allowing the people to seek low-cost generic treatments for sofosbuvir in government hospitals. 

In some issues related to the public health crisis, under the World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, various country governments can issue the compulsory licensing, as long as the drug patent rights have not expired. The generic drugs can be introduced by the government or the commissioned pharmaceutical company, but can only be used in government hospitals. 

Disclaimer: The above-mentioned products, services and personal cases shown in the articles and advertisements are for reference only. They cannot be used as the basis of doctor consultation. 

Source: Sin Chew Daily, Health Section, 18 Jun 2018, Pg. 19

Clinical Research Centre (CRC) Hospital Sultan Ismail, Johor Bahru

Hospital Sultan Ismail Johor Bahru (HSIJB) began fully operational in May 2006 and was the second hospital in Malaysia that has started using the electronic system Total Hospital Information System (THIS). It currently has 18 specialists services with 21 subspecialties. HSIJB is a tertiary specialist hospital that is the main oncology centre in the southern region of Malaysia. Besides having a paediatric palliative care centre, it also has its own Clinical Research Centre (CRC) that supports both Industry Sponsored Research (ISR) as well as Investigator Initiated Research (IIR). Read more

Have I Done Enough? – Recruitment and Retention

Read more contents from CRM Bulletin Issue 14. Download here!

The success or failure of a trial strongly lies in the recruitment achievements.  Although clinical trials has been conducted in more than few decades, the recruitment continues to be an immerse challenge for most trials. Investigators enthusiasm for ambitious recruitment targets is often misguided. This is called as “Lasagna Law” where by, investigators overestimate the pool of available patients and at the end of the study fails to deliver the promised target. Read more

Unraveling the Methodology of Risk Based Monitoring

Read more contents from CRM Bulletin Issue 14. Download here!

The growth of clinical research is extraordinary and the number of clinical trials being approved to run is increasing rapidly in the world. Therefore, there is an increase in the complexity of newer trials as well as the cost of monitoring them. This increasing complexity leads to clinical sites generating more errors during data collection, thus causing delays in the data-cleaning process. Furthermore, there is a higher chance for deviations to occur and be unnoticed at a clinical site. These deviations may directly affect patient safety and data integrity, and is in violation of Good Clinical Practice (GCP). Considering this development, most pharmaceutical companies (or sponsors) are moving towards a new monitoring approach called the Risk-Based Monitoring (RBM) model. For RBM to be defined, a comparative analysis needs to be made between RBM and the traditional monitoring model. Read more

Site Selection – What a Sponsor Looks For?

Read more contents from CRM Bulletin Issue 14. Download here!

Clinical research is a process that studies a new treatment effectiveness. While it is a very good opportunity for doctors to study the disease development and treatment, the conduct of clinical research by doctors themselves requires a huge budget. Industry Sponsored Research (ISR) provides a good opportunity for doctors to be involved in new and ground-breaking research that may potentially change the course of treatment globally. The number of clinical research has been increasing over the past 10 years. Almost 50% of all trials registered in clinicaltrial.gov showed that it is conducted in Asia. However, less than 1% of the registered clinical research came to Malaysia. To increase the number of ISR in Malaysia, feasibility process plays an important role. Read more

Malaysia Spearheads Stem Cell Research

Read more contents from CRM Bulletin Issue 14. Download here!

The Ministry of Health (MOH) Ampang Hospital is embarking on a pioneering stem cell research exploring the use of mesenchymal stem cells (MSCs) in acute graft-versus-host-disease (aGVHD). While this innovative treatment has already been approved in several countries, it has so far only been used as salvage therapy after failing steroids and other immunosuppresants, and rarely employed as a front-line therapy. Steroid refractory aGVHD has a dismal prognosis with mortality in excess of 90% and no viable second-line options.1Working in collaboration with Cytopeutics®, a local company with an impressive track record of basic and clinical trials in stem cell, this Phase I-II double blind randomized clinical trial has been approved by the Medical Research Ethics Committee (MREC) and the National Stem Cell Ethics and Research Sub-committee (NSCERT). More centres are expected to participate in the trial locally and abroad including Singapore and Australia. The success of the treatment will provide a real chance of the patient surviving against the odds as well as put Malaysia on the map in the field of stem cell advances. Read more

Research Personality: Dr Sri Wahyu Taher

Dr Sri Wahyu Taher is currently the Consultant Family Medicine Specialist and Head of Clinic, Klinik Kesihatan (KK) Simpang Kuala Alor Setar, Kedah. She is also the Head of CRC Unit KK Simpang Kuala which is one of the research unit in primary care clinic in the state of Kedah.

Dr Sri Wahyu Taher attained her BSc Medical Science from St. Andrews University Scotland in 1988. She proceeded with MBChB from Glasgow University Scotland in 1991. She returned to Malaysia in 1993 to work in Hospital Alor Setar and obtained her Masters in Family Medicine UKM in the year 2000. She had 2 years of experience working in Scotland. She then continued with subspecialty training in Non-Communicable Disease Management Primary Care from Monash University Victoria Australia in 2006. The fellowship training was an eye opener and upon returning to Malaysia in 2007 she started to get involved with ISR in 2008. Read more

Hospital Miri 2nd Top Recruiter Globally for Respiratory Study

Standing L-R: Dr Tey Chin Wei, Dr Koh Huah Chian, Dr Andy Tang Sing Ong. Seating L-R: Salina, Dato’ Dr Fam Tem Lom, Dr Desmond Samuel(PI), Wan Ainor.

Congratulations Hospital Miri, Sarawak for being the 2nd Top Recruiter Globally for a respiratory study recently. The study team is lead by Principle Investigator, Dr. Desmond Samuel and supported by 2 of CRM’s study coordinators Ms. Salina Lisang and Wan Ainor. We hope for more great success story from the site. Thank you for making Malaysia proud!

Dr Chua Ee Yong, Sub-PI

Dr. Lee Ling Yuin, Sub-PI

 

Clinical Research Malaysia Forms Two Global Partnerships and New Foreign Investments

L-R: Dr. Akhmal Yusof (CEO of CRM), Mr. Zabidi Mahbar (Executive Director of Strategic Planning (Manufacturing), Malaysian Investment Development Authority (MIDA), YBhg Datuk Dr. Noor Hisham Abdullah (Director General of Health, Malaysia), Dr. Hytham Al-Masri (President & CEO of Hematogenix) and Dr. Yooni Kim (Executive Director, Asia Operations, Novotech)

PUTRAJAYA, 20 April 2018 – Hematogenix, a global leader in integrated laboratory services, and Novotech, Australia’s largest independent contract research organization (CRO) have both signed a Memorandum of Understanding with Clinical Research Malaysia (CRM) to establish strategic partnerships in clinical research.

The inking of this MoU with Hematogenix will have the potential to set Malaysia apart from its Asia counterparts as Hematogenix intends to invest in setting up its central laboratory services (that focuses on cancer related research and clinical trials) in this country. Hematogenix is only one of a handful of providers of such services in the USA and a leader in immune-oncology testing for drug development. The establishment of their central laboratory services will be the first of such kind in the Asia region and is anticipated to be the largest globally in due time, surpassing the one in Chicago. Through its Asia operations, Malaysia can expect to attract more global clinical trials into the country, upscale the Malaysian medical talents and bring in more investments into the nation’s economy.  Read more