clinical-trials-v2

---

name: clinical-trials-v2 description: Use this skill whenever the user asks about clinical trial status, recruitment, trial phases (1-4), outcomes, trial registries, NCT IDs, or any query on ClinicalTrials.gov data. Real-time lookup of trial protocols, results, enrollment status, sponsors, and interventions via ClinicalTrials.gov API v2. Handles: 'What is the latest status of NCT04368728?', 'Find Phase 3 BTK inhibitor trials currently recruiting', 'Show primary outcomes for this trial', 'Which trials use Pembrolizumab?', 'Recruiting trials for Acute Myeloid Leukemia'. Real-time, single-query ≤1000 records. Delegates to: aact-bulk-trials (bulk >10k), pubmed-eutils (PubMed literature), medical-evidence-grading (GRADE rating), evidence-appendix-sync (reference formatting). keywords:

• clinical-trials
• clinicaltrials-gov
• clinicaltrials.gov
• 临床试验
• 试验注册
• 招募状态
• nct
• nct-id
• trial-registry
• recruitment-status
• recruiting
• phase-1
• phase-2
• phase-3
• phase-4
• rct-lookup
• sponsor-search
• interventional
• observational
• primary-outcome
• secondary-outcome
• real-time-api license: MIT

---

ClinicalTrials.gov API v2 实时检索

封装 ClinicalTrials.gov 官方 API v2,为医学证据检索体系提供"实时官方源"原子能力。

0. Auto-Trigger 示例

用户 prompt	应触发	原因
"我要查血液科 IFI 相关的招募中临床试验"	✅ clinical-trials-v2	实时招募状态查询
"BTK 抑制剂的 Phase 3 试验有哪些"	✅ clinical-trials-v2	intervention + phase 过滤
"给我所有近 5 年完成的曲霉病试验的 results 数据"	✅ clinical-trials-v2 (get_study_outcomes)	主次终点 + 已发布结果
"NCT04368728 现在到哪一阶段了"	✅ clinical-trials-v2 (get_study_details)	单 NCT 详情
"我要批量分析过去 10 年血液病所有试验"	❌ → aact-bulk-trials	全量 SQL,本地镜像
"找 PubMed 上 RCT 文献"	❌ → pubmed-eutils	文献库非试验注册
"这条 RCT 的证据等级是 A 还是 B"	❌ → medical-evidence-grading (上层调用本 skill)	GRADE 评级编排

1. 定位与边界

只做

• 通过 https://clinicaltrials.gov/api/v2/studies 实时检索单个/批量试验
• 单次请求 ≤ 1000 条记录
• 返回完整 protocol + results 模块结构化数据

不做(显式委托)

任务	委托给	关系
大批量历史分析 (>10k / 全库 SQL)	aact-bulk-trials	互补:批量·SQL·历史全量 vs 本 skill 实时·单查·≤1000
关联 PubMed 文献 / NCT→PMID	pubmed-eutils	上游:文献检索后取 NCT 详情
RCT 证据等级 GRADE A/B/C/D	medical-evidence-grading	上层:它编排本 skill 提取 RCT 元数据后评级
引文落入报告附录 C	evidence-appendix-sync	终下游:source_url + NCT 直接落参考文献表
全文 XML 解析	bioc-fulltext-fetch	不重叠
系统综述 PRISMA 编排	systematic-review	不重叠

与 aact-bulk-trials 详细对比

维度	clinical-trials-v2 (本 skill)	aact-bulk-trials
数据源	实时 API	每日同步的 PostgreSQL 镜像
单次规模	≤1000 条	无限(SQL JOIN 全表)
延迟	实时 (T+0)	T-1
查询能力	REST query DSL	完整 SQL
适用场景	单试验最新状态 / 小批量招募检索	全库统计 / 历史趋势 / 多表 JOIN
速率限制	建议 ≤5 RPS	仅本地 IO

跨平台无锁声明

本 skill 仅依赖标准 HTTP + Python stdlib + httpx,无任何 Claude Code / Codex / Cursor 平台特定 API。可直接在三平台间迁移。

2. 认证与速率

无需 API key

ClinicalTrials.gov API v2 是开放 API,无需注册或 API key。

建议 User-Agent

HEADERS = {
    "User-Agent": "ClinicalTrialsV2-Skill/1.0 (medical-evidence-retrieval; [e-mail])",
    "Accept": "application/json",
}

速率限制

• 官方未强制 RPS 限制,但建议自约束 ≤5 RPS
• 实现指数退避: 429/503 → 退避 2^n * 0.5s, 最多 5 次重试

3. 安装与依赖

pip install httpx tenacity pydantic

仅依赖标准 HTTP 客户端,无需特殊 SDK。

4. 核心 API 设计

统一返回 dataclass

from dataclasses import dataclass, field
from typing import Optional

@dataclass
class TrialRecord:
    nct_id: str
    title: dict                      # {"brief": str, "official": str}
    status: str                      # RECRUITING / ACTIVE_NOT_RECRUITING / COMPLETED / ...
    phase: list[str]                 # ["PHASE2", "PHASE3"]
    study_type: str                  # INTERVENTIONAL / OBSERVATIONAL / EXPANDED_ACCESS
    condition: list[str]
    intervention: list[dict]         # [{"type": "DRUG", "name": "Pembrolizumab"}]
    sponsor: dict                    # {"lead": str, "class": "INDUSTRY"|"NIH"|...}
    enrollment: Optional[int]
    enrollment_type: Optional[str]   # ACTUAL / ESTIMATED
    start_date: Optional[str]
    completion_date: Optional[str]
    primary_outcomes: list[dict]     # [{"measure": str, "time_frame": str}]
    locations: list[dict]            # [{"facility": str, "city": str, "country": str, "status": str}]
    has_results: bool
    last_update_posted: Optional[str]
    source_url: str = field(init=False)

    def __post_init__(self):
        self.source_url = f"https://clinicaltrials.gov/study/{self.nct_id}"

5 个核心检索函数

4.1 search_studies(query, filters)

综合检索入口,支持自由文本 + 结构化过滤器组合。

def search_studies(
    query: str,
    *,
    recruitment_status: list[str] | None = None,    # ["RECRUITING", "ACTIVE_NOT_RECRUITING"]
    phase: list[str] | None = None,                  # ["PHASE2", "PHASE3"]
    study_type: str | None = None,                   # "INTERVENTIONAL"
    country: str | None = None,
    sponsor: str | None = None,
    date_from: str | None = None,                    # "2023-01-01"
    date_to: str | None = None,
    page_size: int = 100,                            # ≤1000
    max_results: int = 500,
) -> list[TrialRecord]:
    """组合查询。query 走 query.term,过滤器映射到 filter.* 参数。"""

4.2 get_study_details(nct_id)

按 NCT ID 获取完整 protocol + results。

def get_study_details(nct_id: str) -> TrialRecord:
    """GET /api/v2/studies/{nct_id}?format=json"""

4.3 search_by_condition(condition_term, ...)

疾病专项检索,内部映射到 query.cond。

def search_by_condition(
    condition_term: str,                  # "Multiple Myeloma" / "AML"
    *,
    status: list[str] | None = None,
    phase: list[str] | None = None,
    country: str | None = None,
    max_results: int = 200,
) -> list[TrialRecord]:

4.4 search_by_intervention(intervention_term, intervention_type)

干预专项检索,映射到 query.intr。

def search_by_intervention(
    intervention_term: str,                          # "Pembrolizumab" / "CAR-T"
    intervention_type: str | None = None,            # "DRUG"|"DEVICE"|"BEHAVIORAL"|"BIOLOGICAL"
    *,
    status: list[str] | None = None,
    max_results: int = 200,
) -> list[TrialRecord]:

4.5 get_study_outcomes(nct_id)

专取主/次要终点 + 已发布结果(若 hasResults=True)。

def get_study_outcomes(nct_id: str) -> dict:
    """
    返回:
    {
      "primary_outcomes": [...],
      "secondary_outcomes": [...],
      "has_results": bool,
      "results": {...} | None,         # outcomeMeasuresModule + adverseEventsModule
    }
    """

5. 参数化过滤器枚举(精简)

最常用的 4 类枚举值速查;完整枚举 + 端点字段清单 + DSL 语法见 references/enums-and-endpoints.md。

类型	常用值
recruitment_status	RECRUITING · ACTIVE_NOT_RECRUITING · COMPLETED · TERMINATED (完整 9 值见 references)
phase	PHASE1 · PHASE2 · PHASE3 · PHASE4 (+ EARLY_PHASE1 / NA)
study_type	INTERVENTIONAL · OBSERVATIONAL · EXPANDED_ACCESS
intervention_type	DRUG · DEVICE · BIOLOGICAL · BEHAVIORAL (完整 11 值见 references)

6. API v2 端点映射(精简)

函数	HTTP	关键参数
search_studies	GET /api/v2/studies	query.term + filter.*
get_study_details	GET /api/v2/studies/{nct_id}	format=json
search_by_condition	GET /api/v2/studies	query.cond
search_by_intervention	GET /api/v2/studies	query.intr
get_study_outcomes	GET /api/v2/studies/{nct_id}	fields=outcomesModule,resultsSection

完整字段映射 + 分页 (pageToken) + fields= 裁剪语法详见 references。

7. 标准请求示例

import httpx

BASE = "https://clinicaltrials.gov/api/v2/studies"

def _fetch(params: dict) -> dict:
    with httpx.Client(headers=HEADERS, timeout=30.0) as client:
        r = client.get(BASE, params=params)
        r.raise_for_status()
        return r.json()

# 示例: 检索"多发性骨髓瘤 + PHASE3 + RECRUITING"
data = _fetch({
    "query.cond": "Multiple Myeloma",
    "filter.overallStatus": "RECRUITING",
    "filter.phase": "PHASE3",
    "pageSize": 100,
    "format": "json",
})

8. 失败模式与处理(必读)

#	失败模式	触发条件	处理策略
1	API rate limit	单 IP > 5 RPS,返回 429/503	tenacity 指数退避 (0.5s × 2^n,上限 8s,最多 5 次);批量任务建议 sleep(0.25) 节流
2	NCT ID 格式错误	非 ^NCT\d{8}$ (例如 NCT123 / nct04368728)	validate_nct_id() 上游校验,直接抛 InvalidNCTIdError,不发请求
3	试验未发布 results	hasResults=False 或 resultsSection 缺失子模块	get_study_outcomes 优雅降级,返回 {"has_results": False, "results": None},不抛错
4	query DSL 解析错	query.term 含未转义括号/AND-OR 优先级错,API 返回 400	抛 InvalidQueryError,记录原 query,提示用户使用 search_by_condition / search_by_intervention 而非 raw query
5	国家/地点过滤模糊匹配失败	filter.locStr=Beijing 漏掉 "Peking"/"Beijing, China"	文档说明使用 ISO 国家码或 query.locn,提供常见城市同义词表(见 references)
6	NCT 不存在 (404)	已撤回或拼写错	抛 TrialNotFoundError,不重试
7	status 字段滞后真实情况	sponsor 自报,可能仍标 RECRUITING 但实际已停	严肃决策需交叉验证 last_update_posted 并提示用户

from tenacity import retry, stop_after_attempt, wait_exponential, retry_if_exception_type
import re

NCT_PATTERN = re.compile(r"^NCT\d{8}$")

def validate_nct_id(nct_id: str) -> str:
    if not NCT_PATTERN.match(nct_id):
        raise InvalidNCTIdError(f"非法 NCT ID: {nct_id!r},应为 NCT + 8 位数字")
    return nct_id

@retry(
    stop=stop_after_attempt(5),
    wait=wait_exponential(multiplier=0.5, min=0.5, max=8),
    retry=retry_if_exception_type((httpx.HTTPStatusError, httpx.TimeoutException)),
    reraise=True,
)
def _fetch_with_retry(params: dict) -> dict:
    ...

9. 输出规范

• 永远返回结构化 dataclass,不返回 raw JSON
• source_url 字段供下游引文用
• list 字段空值用 [] 而非 None
• 日期统一 YYYY-MM-DD 字符串(原始 API 可能返回 YYYY-MM,前端补 -01)

10. 跨 Skill 协作链(显式)

[pubmed-eutils]               (上游: 文献找到 PMID, elink 拿到 NCT)
        │
        ▼
[clinical-trials-v2]  ←─ 本 skill (单查 ≤1000 / 实时)
        │
        ├──→ [aact-bulk-trials]      (互补: 大批量历史时切换)
        │
        ├──→ [medical-evidence-grading]  (上层: RCT 自动评 GRADE A)
        │           │
        │           ▼
        └──→ [evidence-appendix-sync]    (终下游: 落 NCT 到附录 C)

与 medical-evidence-grading 集成

# medical-evidence-grading 调用本 skill 提取 RCT 元数据
trial = get_study_details("NCT04368728")
grade_input = {
    "study_type": trial.study_type,           # INTERVENTIONAL
    "phase": trial.phase,                      # ["PHASE3"]
    "enrollment": trial.enrollment,            # 样本量
    "has_results": trial.has_results,
    "primary_outcomes": trial.primary_outcomes,
}
# → grading skill 判定 RCT + Phase 3 + 样本 ≥1000 → GRADE A

与 evidence-appendix-sync 集成

for trial in search_studies("CAR-T", recruitment_status=["RECRUITING"]):
    appendix.add_reference({
        "type": "clinical_trial",
        "id": trial.nct_id,                    # NCT04368728
        "title": trial.title["official"] or trial.title["brief"],
        "url": trial.source_url,               # https://clinicaltrials.gov/study/NCT...
        "accessed": today_iso(),
    })

与 pubmed-eutils 上游集成

# 1) PubMed 文献 → NCT
nct_ids = pubmed_eutils.elink(pmids=["38123456"], db="clinicaltrials")
# 2) 取试验详情
trials = [get_study_details(nct) for nct in nct_ids]

11. 测试清单

• get_study_details("NCT04368728") 返回 BNT162b2 完整 protocol
• search_by_condition("Acute Myeloid Leukemia", status=["RECRUITING"]) ≥10 条
• search_by_intervention("Pembrolizumab", "DRUG") 返回 KEYNOTE 系列
• get_study_outcomes("NCT00000000") 对未发布结果试验返回 has_results=False
• 不存在的 NCT 触发 TrialNotFoundError
• 5 次连续 429 后正确退避并最终返回结果
• 分页超过 1000 条时使用 pageToken 自动续取

12. 限制与注意

• API v2 已替代 v1(2024-06 起 v1 deprecated),本 skill 仅使用 v2
• hasResults=True 不代表所有 endpoint 已发布;需检查 resultsSection 各子模块
• locations 数组可能极大(国际多中心试验 >500 站点),按需用 fields 参数裁剪
• 单次 ≥1000 条请用 aact-bulk-trials 改走本地镜像
• 试验 status 字段可能滞后真实招募情况(由 sponsor 自报),严肃决策需交叉验证
• 不要把本 skill 用于"导出全库做统计"——会被识别为滥用模式