520 Clinical Trial Day We are in the midst of rapid changes in the clinical trial environment!

Wen/AprilChen
520, the annual "International Clinical TrialDay" has arrived again this year because of the GLOBAL OUTBREAK of COVID-19, the development of clinical trials, both internationally and in China, is facing unprecedented challenges and opportunitiesthe beginning of the control trial: on May 20, 1747, Scottish Naval Medical Officer James Lind, on the Salisbury, selected 12 scurvy crew members, divided into six pairs, each receiving a different dietary supplement each day, such as one pair getting cider, the other getting sea water, the other getting orange, the other getting lemon, etc., introducing the concept of the control trial, which became the origin of the modern clinical trialplacebo application: In 1863, American doctor Austin Flint gave 13 rheumatologists herbal extracts instead of other therapeutic drugs that were widely used at the time, and in his book describes the study as "a regularly given, in the ward I am responsible for, known as the placebo therapy, and in this way it gained the trust of patients"double-blind control trial: In 1943-1944, the British Medical Research Council (MRC) orchestrated an experiment to study the treatment of rod clymycin as a treatment for the common coldThe first multi-center double-blind trial was conducted at 11 factories and three post offices in the UK, and doctors and patients did not know which treatment was being usedprotect the rights and interests of subjects: in 1964, the World Medical Association (WMA) issued in Helsinki the ethical principles of medical research relating to humanity, the Helsinki Declaration, which was revised every few years, most recently in 2013Clinical trials need to be patient-centric and understand patient needs so that new drugs can be developed that better meet patient needsThe origins of this concept date back to the AIDS social movement 30 years agoaids patients in the 1987s because of dissatisfaction with the FDA's slow treatment of AIDS research and drug approval speed, in New York, the establishment of AIDS advocacy organization ACTUP (AIDSCoalitiontoPower Power), began to lead a series of global AIDS demonstrations, among them, October 11, 1988 anti-FDA demonstrations successfully led to the same day the FDA headquarters shutdown, anti-FDA demonstrations eight days later, the FDA issued new regulations, committed to speed up the review of AIDS drugsThen, the FDA began to listen to patients in the study of AIDS drugs, becoming the beginning of a "patient-centered" clinical trial modelin 2012 the FDA formally established a patient-centered drug development program under the Prescription Drug Users Pay Act (PDUFA), and later encouraged the inclusion of patient representatives as consultants in the drug approval process, patient-centered drug development programs, and the issuance of relevant official guidance documentslast October, ich first revised (R1) to the guidelines for overall considerations in EE8 clinical trials, the most important of which was to encourage increased patient participation in clinical trial designNow, in addition to the official drug supervision, the major pharmaceutical companies are also through the patient organizations to establish patient counseling and other forms of cooperationIn order to increase the transparency of clinical trials, give patients and relevant researchers equal access to clinical trial information, reduce the information gap on clinical trials in low- and middle-income countries, and ultimately enhance the effectiveness and value of the scientific evidence base for clinical trials worldwide, WHO established the WHO International Clinical Trial Registration Platform (ICTRP) in 2006From a global perspective, the key role of ICTRP is to increase global transparency and integrate into a search portal, and in order to achieve this goal, ICTRP wants to increase the number of countries that can build its own national clinical trial registry (who meets WHO standards), or through enforcement policies that require that clinical trials be registered on ICTRPwhen ICTRP was founded in 2006, it included only three registered platforms: ISTCTN in the UK, ANZCTR in Australia and New Zealand and ClinicalTrials.gov in the US Today, clinical trial registration platforms are included in 18 countries, including Chictr.org.cn in China No clinical trial is perfect, and factors such as missing data or deviations in the program make it difficult to represent the outcome of the drug in a larger patient population, and expanding the trial population and real-world research (RWS) may complement this better FDA released a succession of MasterProtocols drafts and rich design guidelines in September and March this year to encourage greater diversity in the pilot group and include as many representative trial groups as possible in addition to this, Real World Evidence (RWE) based on relevant and reliable data in RWS is a new trend in clinical research, and relevant norms and incentives in countries such as The United States, such as the United States, first passed the 21st Century Cure Act in December 2016, to encourage the FDA to adopt RWE-enabled drug and medical device approval decisions However, on January 7, 2020, China's State Drug Administration first promulgated the Special Principles on RWE, "Guidelines for Real World Evidence Support drug Research and Development and Review (Trial)," which refers to the fact that RWE can be used to support the approval of drugs, including the approval of the registration and listing of new drugs, the approval of the listed drug change specification, the approval of the listing and evaluation, the approval of the old Chinese medicine experience and the preparation of Chinese medicine medical institutions On March 26, 2020, the China Drug Administration approved the first medical product to be approved for listing using RWE, and El Jian's "glaucoma drainage tube" product was evaluated for human differences through clinical real-world evidence On May 18th the FDA released a draft of the guidelines on RWE's guidelines for supporting children's drug research, and the use of RWS will be expanded, but it will still require the cooperation of regulators, pharmaceutical companies, medical institutions and big data platforms China has made many reforms to the development of clinical trials in the past 5 years, some of which include: optimizing the clinical trial approval process, the 60-day default system, that is, the review body from the date of acceptance of 60 working days, without giving a negative or challenge disapproved review opinion is considered consent , the applicant can carry out clinical trials in accordance with the submitted program; Clinical trial institutions are adjusted from accreditation to record management, so that more hospitals can participate in clinical research, to formally incorporate the approval of drug expedited review and approval in the clinical trial process into the Drug Registration Management Measures, and more clinical trial spree specifications and technical documents, such as the release of a new version of the Drug Clinical Trial Quality Management Practices on April 23 this year, which is the first update issued by the GCP since September 1, 2003 At the same time, CDE in May this year also released clinical trial data submission, adaptive design and other guiding principles for comments We have come a long way since 1747, and the methods, efficiency, technology and scale of clinical trials have changed dramatically, but we have always been able to find better treatments for our patients.