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.
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
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).
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
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.
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