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Tumor Discovery Practice and consideration of master protocol design

Table 4. (Continued)
Field Trial NCT number Description Design Intervention Sample size Primary
endpoint
of patients admitted receiving
to intensive care with organ
community-acquired support in
pneumonia the intensive
care unit
at day 21
(primary
endpoint
for patients
with
suspected
or proven
COVID-19
pandemic
infection)
Others UPMC NCT03861767 Platform trial to Phase 3, triple-blind, Metformin ER 302 actually Hospital
REMAP [61] determine the comparative, enrolled free days
effect of various randomized trial
interventions to
improve patient
outcome as defined
by hospital-free days
at day 90 for adult
patients undergoing
elective surgery
CT: Chlamydia trachomatis; NG: Neisseria gonorrhoeae

6.2. Rare diseases the study of multiple therapies effectively and efficiently.
For example, REMAP-CAP is a platform trial to test various
Rare diseases affect only a small number of people, so
trials for rare diseases tend to enroll fewer patients. Master interventions for patients admitted to intensive care with
protocols, especially umbrella or platform designs, can community-acquired pneumonia, which launches the
[54]
be chosen to address the rarity of the diseases using a pandemic COVID-19-specific domains now . This trial
common control, reducing the chance of assignment to shortens the time and cost of preparing a new clinical trial,
placebo, comparing several treatments, and the ability thus accelerating the development of COVID-19 therapies.
to pool data across treatments . Indeed, platform trials 6.4. Traditional Chinese medicine
[52]
incorporate more adaptations for therapies to enter or
leave the platform based on emerging treatments, sharing In TCM, multiple diseases in different people with the same
trial resources perpetually. INHIBIT is a platform trial syndrome (Zheng) may be treated in the same manner [55,56] ,
investigating treatments to prevent and eliminate inhibitor which is consistent with the design of a basket trial. Therefore,
formation in patients with hemophilia. It involves two basket trials are good choices to study a single TCM among
trials within one protocol that capitalize on the same different diseases with the same syndrome (Zheng). BOSS
centers, laboratories, and visit timing while allowing other is the first TCM basket trial evaluating the BuqiTongluo
drugs to enter the trials if they emerge . for qi deficiency and blood stasis syndrome consisting
[53]
of stable angina pectoris, ischemic stroke, and diabetic
6.3. Emerging infectious diseases peripheral neuropathy [57,58] . This study accurately evaluated
As mentioned above, master protocol trials play an the independent clinical efficacy of treatment for each
essential role in addressing the public health needs created disease and innovatively embodied the advantage in TCM
[55]
by the current COVID-19 pandemic. Moreover, they are of of “treating different diseases with the same treatment” .
great significance for the emerging infectious diseases that Master protocols can increase the efficiency in trial
might occur in the future. Such trials can be constructed administration and infrastructure, facilitating the
ahead of time with pre-prepared protocols, algorithms, and evaluation of multiple therapies or diseases. Therefore,
infrastructure, which are ready for an outbreak and enable in our future research, we would sincerely refer to

Volume 2 Issue 2 (2023) 14 https://doi.org/10.36922/td.342