Patient Pathways
Patient B
Patient B is excluded from trial enrollment as they can't meet the high clinical and personal barriers to entry.
After appropriate HCP referral, patients can often face hurdles in meeting trial participation requirements and provisioning the required financial and personal support.
1. Patients' diagnostic and treatment journeys are unique:
Diagnostic and treatment journeys leading to consideration of a CAR-T therapy vary significantly from person-to-person.
The FDA approves the trials...and the doctor cannot deviate from the protocol. An example I'll give is the bone marrow biopsy. In the three times she had Lymphoma, she never had any positive bone marrow, and because of the protocol she had to get four different bone marrow biopsies...it got to be too much.
The caregiver's perspective
2. Socioeconomic factors and complex inclusion/exclusion criteria prevent patient participation
Complex inclusion/exclusion criteria and a lack of access to resources can preclude potential study participants, especially from underrepresented populations.
There is socioeconomic disparity between those that can go through CAR-T and those that financially or logistically cannot.
The HCP's perspective
パレクセルでは、患者さんの治療経過に対する深い理解を基盤とした革新的な試験デザインを提供しています。弊社の細胞・遺伝子治療センター オブ エクセレンスは、開発ライフサイクル全体を通じてベストプラクティスを収集し、頻繁に変更される規制上のハードルを乗り越え、患者さんへの治療を加速させるために、お客様を支援します。パレクセルはスポンサーが規制上の経路を管理し、コンプライアンスリスクを軽減することで、概念実証 (PoC)から販売承認までのプロセスをより迅速かつ効率的に進められるようサポートします。
パレクセルと協力して、細胞・遺伝子治療の開発を加速し、市場での成功の可能性を最大限に高めましょう。