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"Unveiling the Mystery of Pharmaceuticals: $1 Billion Journey from R&D to Market"
pine Webmaster of Pineapple
2008/09/26 15:13
508 topics published
【2006/07/19 United Daily News】【Reporter Wei Xinxin / Special Report】

How much of the cost of a clinical trial for an unlisted new drug, after deducting necessary expenses such as testing, ends up in the hands of the physician? Industry insiders familiar with clinical trial operations note: "It could range from zero to everything!"

For example, a foreign pharmaceutical company plans to introduce a new drug and will conduct clinical trials at five medical centers across Taiwan, aiming to enroll 100 patients. Excluding costs for sample testing, the total expense is approximately 10 million NTD.

Where does this 10 million NTD go? After the clinical trial design for the new drug is completed, a lead physician must be hired, along with research assistants or nurses, and patients must be recruited. Each of these roles can claim compensation, but the compensation might directly end up in the physician's pocket.

How so? The pharmaceutical company might budget a monthly salary of 50,000 NTD for a research assistant for one year. However, since the physician usually already has an assistant, the cost of hiring an assistant can be saved. As for research nurses, since hospitals already have nursing staff, it's not always necessary to hire additional personnel.

Some trials budget for participant compensation, but patients may not necessarily receive it. Many believe that participants in clinical trials are like lab rats, but if the trial drug is an anticancer medication, it might be the last hope for cancer patients. In such cases, patients are eager to join the trial and may not even think about demanding compensation.

Of course, the above scenarios are extreme, and physicians who exploit clinical trial funds are in the minority.

Physicians who can lead clinical trials gain not only financial benefits but also prestige and recognition. Industry insiders liken it to physicians being able to trial new drugs ahead of their peers, with their names appearing on the trial results, which is a form of academic acknowledgment.

Clinical trials are so crucial for physicians, and pharmaceutical companies are very selective in choosing the lead physicians.

Industry insiders point out that from development to market, a new drug is estimated to cost 1 billion NTD, with at least 60% of the R&D budget spent on clinical trials.

Clinical trials determine the success or failure of a drug and are the foundation for marketing and promotion. The more influential the lead physician is in the medical community, the more it helps the subsequent sales of the drug.

A pharmaceutical marketing manager candidly said: "Clinical trials must be conducted by 'big names'! If the 'big names' don't do it, then it must be done by the physicians they designate!" Who are the 'big names'? They are the most authoritative physicians in the treatment field, who also have the power to decide which drugs are used in hospitals, much like Professor Zaizen in the Japanese drama "Shiroi Kyotō" or Professor Tō before his downfall.

Moreover, most of Taiwan's 'big names' are concentrated in two hospitals: National Taiwan University Hospital and Taipei Veterans General Hospital. Industry insiders explain that domestic new drug clinical trials are generally divided into two types: those applying for a drug license from the Department of Health and those for new drugs entering hospitals. National Taiwan University Hospital and Taipei Veterans General Hospital are the only two hospitals in Taiwan that require new drugs to undergo another clinical trial before entering the hospital, even if they already have a Department of Health drug license.

To save time and money, pharmaceutical companies often strive to have the drug license application clinical trials conducted directly at National Taiwan University Hospital and Taipei Veterans General Hospital, thus "killing two birds with one stone."

If a drug can enter National Taiwan University Hospital, it is equivalent to entering other secondary hospitals with good relations with National Taiwan University Hospital; if it can enter Taipei Veterans General Hospital, almost all Veterans Affairs Commission hospitals will follow suit. Industry insiders describe it as: "Entering National Taiwan University Hospital and Taipei Veterans General Hospital is like unblocking the Ren and Du meridians."

Regarding the Department of Health's expansion of clinical trial hospitals from 17 medical centers to over 130 regional and district hospitals, industry insiders assess that the clinical trial ecosystem will not change.
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